The Psoriasis Association 'Bring Psoriasis To The Surface' For Psoriasis Awareness Week

The Psoriasis Association encourage those living with psoriasis to talk more openly with friends and family about their condition to increase their confidence and self esteem to ultimately improve their personal relationships.



Psoriasis Awareness Week runs from 1st - 7th November 2010. To mark the week The Psoriasis Association are launching a campaign aimed at empowering those living with psoriasis to talk about their condition to friends and family and 'Bring Psoriasis to the Surface'.



The campaign aims to encourage those living with psoriasis to openly discuss their condition with close friends and family, to help improve their confidence and self-esteem, leading to stronger relationships.



Psoriasis affects over a million people in the UK; between 2 per cent and 3 per cent of the population.[i] It is a chronic and lifelong condition, presenting itself as red, sore areas and white itchy plaques on the skin.


Helen McAteer, CEO of The Psoriasis Association says; "Psoriasis can be a difficult and frustrating condition to live with, many sufferers can feel incredibly isolated, which is often made even worse by negative misconceptions about the condition. It is important that people with psoriasis do not suffer in silence, The Psoriasis Association are using the Awareness Week as an opportunity to empower those living with the condition and encourage them to talk to their family and friends about how living with psoriasis makes them feel."


Psoriasis can have a profound physical and psychological impact[ii] and can be a complex and difficult condition to live with. Recent research highlights that the quality of life of those living with the condition is greatly affected, with over 50 per cent suffering from emotional distress[iii], and nearly 55 per cent have lost their confidence3 due to the condition.


Jo Hemmings, one of the UKs top psychologists and who lives with psoriasis herself is lending her support to the week; "Psoriasis can have a significant effect on the quality of life of sufferers, not just physically but also socially and emotionally. The condition can greatly impact on the confidence of those living with the condition in terms of their self identity and relationships with others. Open communication is key in allowing those living with the condition to express how they are feeling, allowing any negativity to be discussed and eliminated."


Psoriasis may appear at any age, although research suggests that psoriasis is more likely to occur in adolescence and early adulthood and then again later in life. Onset peaks for women occur at 16 and 60 years old, with similar peaks seen at the ages of 22 and 57 years old for men.[iv] Gender does not appear to play a part. Both men and women are equally as likely to get the disease.[v]


Patient, Claire Strudwicke, from Oxford has lived with the condition for over 30 years says; "This campaign aims to encourage others living with psoriasis to open up, particularly those who have perhaps been recently diagnosed and are learning to live with the condition. Just because symptoms appear on the skin's surface, the impact of a diagnosis of Psoriasis is far from superficial. The more comfortable a person is in the relationship with their own skin condition, the healthier their relationships with others are likely to be. "
















Notes


Psoriasis Awareness Week 2010 will be running across the UK from the 1st - 7th November. During the week there will be various activities taking place all aimed at raising awareness of the condition and encouraging communication.



Helen McAteer is the Chief Executive of the Psoriasis Association. The Psoriasis Association is the leading national membership organisation for people affected by psoriasis, and is a registered charity in England and Wales (no.257414) and Scotland (SC039886).



Jo Hemmings is the UK's No. 1 Celebrity Psychologist. Jo has had psoriasis of the scalp since she was 16yrs old. A trained Behavioural Psychologist, author, Dating and Relationship Coach and broadcaster, Jo specialises in the psychology of celebrity behaviour, whether A-Listers or reality TV stars, and is the Behavioural Expert of choice, discussing the contestants on Britain's Got Talent and The X Factor on Sky News. She also appears regularly commenting on celebrity behaviour and body language as well as news stories on Sky and BBC News. She has been the Behavioural Psychologist on C4's Big Brother's Little Brother since 2008 appearing on all series including Big Brother 11 and Ultimate Big Brother.




[i] British Association of Dermatologists. Topical Treatments for Psoriasis. Patient Information Leaflet. August 2004. Available here.

[ii] Kimball AB, Jacobson C, Weiss S, Vreeland M, Wu Y. The psychosocial burden of psoriasis. Am J Clin Dermatol 2005; 6:383-392.


[iii] Gilbert A K. The Patient Experience Survey. The Psoriasis Association.. May 2010


[iv] Henseler et al. Psoriasis of early and late onset: characterization of two types of psoriasis vulgaris. J Am Acad Dermatol 1985; 13:450-6.


[v] Griffiths CEM, Camp RDR, Barker JN: Psoriasis. In: Rook's Textbook of Dermatology. Burns T, Breathnach, Cox N, Griffiths CEM (eds). Blackwell: Oxford. 7th ed, 2004. p.35.2

Discovery Of Cellular Process That Fights Type 1 Herpes Simplex

A report on the online edition of Nature Immunology informs that our immune system has a new means to fight off the virus of Type 1 herpes simplex (HSV-1). Scientists from the Universit?© de Montr?©al, in a teamwork effort with American colleagues, have discovered a cellular process to identify and fight herpes.

The Canadian Institutes of Health Research supported in part this five-year study - a joint project with Washington University and Pennsylvania State University.



"Once human cells are infected with Type 1 herpes simplex, the virus comes back because it hides and blocks protection from our immune system," writes Luc English, lead author of the study, doctoral student , Universit?© de Montr?©al's Department of Pathology and Cell Biology. "For the first time, our research team has indentified a combative cellular mechanism in this game of hide-and-seek."


English explains, "We've found that the nuclear membrane of an infected cell can unmask Type 1 herpes simplex and stimulate the immune system to disintegrate the virus."


The breakthrough came about while researchers were carrying out various tests in HSV-1 infected mice cells. The simulation of conditions in which Type 1 herpes simplex grows rapidly (periods of low-grade fever between 38.5 and 39 degrees) showed that mechanisms to fight herpes were activated. Research will now focus on studying how triggering the herpes-combating cellular process could be useful in treating other diseases. Results could accelerate the progress of therapies to prevent other bacteria, parasites and viruses.


"Our goal is to further study the molecules implicated in this mechanism to eventually develop therapies against diseases such as HIV or even cancer," says English.


Dr. Michel Desjardins, senior author, professor in the Department of Pathology and Cell Biology at the Universit?© de Montr?©al, believes that alternative treatments might be attainable in about ten years.


"Now that we've identified the novel mechanism in cells that activate immune response to Type 1 herpes simplex, scientists are one step closer to creating new treatments that can activate the defence against this and other viruses," writes Dr. Desjardins. "While it may not be possible to completely eradicate Type 1 herpes simplex in people who are already infected, at the very least, future therapies may be able to keep the virus in its dormant state."


Partners in research:

This study was funded by the Canadian Institutes of Health Research, the Natural Science and Engineering Research Council of Canada, the Fonds de la Recherche en Sant?© du Qu?©bec, the U.S. National Institutes of Health and the foundation Research to Prevent Blindness.


About Herpes

There are two types of herpes viruses:


-- Type 1 herpes simplex that causes facial cold sores.

-- Type 2 that causes genital herpes.


Both types of herpes affect an estimated 80 million people in America alone and there is currently no cure for the condition.


About the study


"Autophagy enhances the presentation of endogenous viral antigens on MHC class I molecules during HSV-1 infection," published in Nature Immunology, by Luc English, Magali Chemali, Johanne Duron, Christiane Rondeau, Annie Laplante, Diane Gingras, Roger Lippe and Michel Desjardins of the Universit?© de Montr?©al in collaboration with Diane Alexander and David Leib of Washington University and Christopher Norbury of Pennsylvania State University.


Universit?© de Montr?©al

Department of Pathology and Cell Biology


Written by Stephanie Brunner (B.A.)

International Psoriasis Council Hosts Second Educational Symposium To Increase Global Knowledge Of Psoriasis

Beginning Thursday, Nov. 19, 2009, the International Psoriasis Council (IPC) will host its second symposium at Baylor University Medical Center in Dallas. The two-day conference brings together dermatologists from Asia, Eastern Europe and Spain to elevate the global understanding of psoriasis and its treatment. Sessions will be facilitated by leading dermatologists and nurses dedicated to psoriasis management and research.


Participating dermatologists and the IPC faculty of experts will discuss a variety of topics ranging from diagnosis and treatment to comorbidities associated with the condition, which can include obesity, cardiovascular disease, lymphoma and depression1. Discussions also will highlight the use of a newer class of drugs, "biologics," which are used in treating patients with moderate to severe cases of the psoriasis.


The faculty will be led by Dr. Alan Menter, Chairman of Dermatology at Baylor University Hospital, Dallas with support from fellow scientists, clinicians and IPC members including Drs. Damien Chaussabel (Baylor Research Institute), Jack Cush (University of Texas Southwestern Medical School and Baylor Research Institute, Dallas), Caitriona Ryan (Baylor Research Institute) and Dan McCoy (Baylor University Medical Center), and Mary Wiatrowski, RN DNC (Baylor).


Psoriasis is a chronic, immune-mediated disease that affects more than 125 million people worldwide, including nearly 7.5 million Americans. The condition results from inflammation in the skin and overproduction of skin cells that accumulate on the surface causing red, scaly plaques that may itch and bleed. In addition to being a painful and potentially debilitating condition, psoriasis often affects patients' everyday work and social life, as a result of the extreme discomfort and embarrassment associated with the skin plaques.


"Psoriasis can severely affect people physically and emotionally," says Alan Menter, M.D., president of IPC and chief of dermatology at Baylor. "We believe that sharing our understanding, learnings and clinical practices is critical to making advances in treating patients with psoriasis and psoriatic arthritis in the U.S. and throughout the world."


According to Karen Baxter Rodman, IPC CEO and executive director, since inception, IPC members and dermatologists from more than 18 countries have collaborated to foster an international environment of discussion among peers. "This symposium, like the first, supports our goal of continuing to increase global knowledge and best practices about this disease. This gathering will offer healthcare professionals and researchers valuable discussions about clinical experiences related to the treatment of patients with psoriasis and psoriatic arthritis."


Financial support for the symposium has been provided by Johnson & Johnson Pharmaceutical Services, a company committed to the research and development of treatment options for dermatologic diseases.


The First Global Symposium


The first symposium was hosted in Dallas at Baylor University Medical Center on October 29 - 31, in concert with World Psoriasis Day. It brought together doctors and researchers from Argentina, Brazil, Chile, Colombia, Ecuador, Ireland, Mexico, Paraguay, Peru, Venezuela, the U.K. and U.S.A. The two-day forum raised awareness among an international community of the health impact psoriasis has on its sufferers. IPC led successful interactions among dermatologists from Central and South America and Europe that enabled the sharing of best treatment practices and perspectives. For the first time, the psoriasis community was able to compare regional epidemiologic knowledge on the prevalence of psoriatic disease as well as highlight country and regional challenges with the management of disease.


About Psoriasis


Psoriasis is a common chronic inflammatory disease that may affect up to 125 million people worldwide with an average age of onset between 20-35 years. Seventy-five percent of all cases occur for the first time before the age of 40. As an immune-mediated disease, psoriasis usually requires long-term treatment for control.


1 Kimball, AB, Gladman, D, Gelfand, JM, et al. National Psoriasis Foundation clinical consensus on psoriasis comorbidities and recommendations for screening. J Am Acad Dermatol. 2008;58:1031-42.


Source
International Psoriasis Council

NeurogesX Provides U.S. Regulatory Update For Qutenza(TM)

NeurogesX, Inc. (Nasdaq: NGSX) announced that the U.S. Food and Drug Administration (FDA) agreed to its proposed study to evaluate Qutenza(TM) in patients with post-herpetic neuralgia (PHN) following pretreatment with an FDA-approved topical anesthetic. As part of its ongoing new drug application (NDA) review, the FDA wants to determine whether pretreatment with an FDA-approved topical anesthetic would provide similar tolerability to the topical agent used as a pretreatment in the clinical development program.


The FDA is currently reviewing the NDA for Qutenza in PHN, which has a Prescription-Drug User Fee Act (PDUFA) date of August 16, 2009. The marketing application is supported by clinical studies of Qutenza which was applied after a 60-minute pretreatment with a commercially available but not a formally FDA approved over the counter (OTC) topical anesthetic.


To fulfill the agency's request, the study protocol involves enrolling approximately 20 patients with PHN to receive the Qutenza patch application after a 60-minute pretreatment with an FDA-approved topical anesthetic (2.5% lidocaine / 2.5% prilocaine) The endpoint of the study is the mean duration of patch application. Previous clinical trial experience using the OTC topical anesthetic indicated that most patients tolerate the full 60-minute procedure. This study is designed to determine whether a similar tolerability profile can be accomplished with an FDA approved topical anesthetic. Patient safety will also be monitored for seven days following treatment. The Company has already commenced screening patients in this study.


Based on the expected short-term nature of the study, NeurogesX could potentially complete enrollment, analyze the data, and submit an NDA amendment prior to the assigned PDUFA date. Submission of this amendment during the review cycle may result in an extension of the PDUFA date.


Anthony DiTonno, CEO of NeurogesX, commented, "With the FDA's approval of our protocol, we believe we can quickly complete the requested study and submit an amendment to our NDA. We are hopeful to submit this additional data before our PDUFA date and that any delay in the FDA's decision will be relatively short. We are optimistic that an FDA decision on our NDA may be available before the end of 2009. On the heels of our European approval, we are optimistic about the potential for a near-term announcement of an EU commercial partnership and we look forward to the potential for a Qutenza launch in Europe and potentially the U.S. in the first half of 2010."


About NeurogesX, Inc.


NeurogesX (NASDAQ: NGSX) is a biopharmaceutical company focused on developing and commercializing novel pain management therapies. Its initial focus is on chronic peripheral neuropathic pain, including postherpetic neuralgia (PHN), painful HIV-distal sensory polyneuropathy (HIV-DSP) and painful diabetic neuropathy (PDN). NeurogesX' late stage product portfolio is led by its product candidate Qutenza, a dermal patch designed to manage pain associated with peripheral neuropathic pain conditions. Qutenza is currently approved in the European Union for the treatment of neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain. NeurogesX submitted a new drug application (NDA) for Qutenza to the U.S. Food and Drug Administration (FDA) which was accepted for filing by the FDA in December 2008 and was given a Prescription Drug User Fee Act (PDUFA) date of August 16, 2009.















NeurogesX' second most advanced product candidate, NGX-1998, is a topically applied, liquid formulation containing a high concentration of capsaicin designed to treat pain associated with neuropathic pain conditions. NGX-1998 has completed three Phase 1 studies and NeurogesX is currently evaluating the timing of entering Phase 2 development.


NeurogesX' early stage product pipeline includes pre-clinical compounds, which are prodrugs of acetaminophen and various opioids. The company has evaluated these compounds in vitro and in vivo and is currently seeking development partners for these programs.


Safe Harbor Statement


This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the "Act"). NeurogesX disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include, but are not limited to the timing and outcome of regulatory decisions and label approval being sought or that may be obtained with respect to the NDA for Qutenza with the FDA, including the PDUFA date for the NDA; enrollment in and outcomes of clinical trials; the timing of the submission of clinical trial data; acceptance of clinical trial data by the FDA in support of regulatory approval; and NeurogesX' plans and expected timing, with regard to seeking partnerships for its product candidates, including potential commercial partnership for Qutenza in the European Union. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to; positive results in clinical trials may not be sufficient to obtain FDA approval; the FDA may request additional clinical trials or other information prior to granting approval for Qutenza; any regulatory approvals which are received may be limited to certain indications; NeurogesX' product candidates may have unexpected adverse side effects or inadequate therapeutic efficacy; and other difficulties or delays in, clinical development of, and obtaining regulatory approval for NeurogesX' product candidates. For further information regarding these and other risks related to NeurogesX' business, investors should consult NeurogesX' filings with the Securities and Exchange Commission.

Local Researcher Shows Botox Clears Up Acne!

The muscle relaxer Botox has now been shown to positively affect the skin as well.


"Botox definitely clears up acne," says Anil Shah M.D. The Chicago plastic surgeon is one of the only doctors worldwide using Botox in an entirely new way. He injects the muscle relaxer directly into the skin to eliminate large pores, oil production, and acne breakouts.


Acne is caused when the skin's sebaceous glands release too much oil, or sebum, into the skin's pores. Bacteria use the sebum as food, multiply, and cause the pore to became inflamed leading to formation of a pimple. "Botox," says Dr. Shah, "stops the production of sebum and deprives those bacteria of food."


The plastic surgeon has treated about 100 patients like Sanjay Nannapaneni. The 35-year-old Chicago resident has had oily skin and constant breakouts all his life. "It's discouraging." he says. "I tried everything: Accutane, light therapy, antibiotics, nothing worked. Then I came across Botox for acne on the Internet. It sounded crazy but I was willing to try anything."


Last August Dr. Shah injected tiny amounts of Botox throughout the dermis of Sanjay's face. The procedure is rare because it's technically difficult. The muscle paralyze has to be injected directly into a layer of skin just 1/25th of an inch thick. If it's injected too deeply it can alter the patient's facial expressions. "Experience here is really essential," says Dr. Shah. The plastic surgeon recently moved his practice from New York back home to Chicago


And the results of Sanjay's treatment? "I haven't had a large breakout since," he says. "I've had random small pimples here and there, but that's it. My skin's less oily and my pores look smaller."


Dr. Shah recently published the only study ever done showing that intradermal Botox lowers the skin's oil production[1]


The plastic surgeon believes Botox works by blocking the chemical acetylcholine in the skin's dermis. Acetylcholine is known to increase the skin's sebum production. In addition, the treatment literally paralyzes the tiny erector pili muscles that surround the skin's pores and cause them to expand.


While other treatments have been used for serious acne, none has been acceptable until now. The medication Accutane decreases oil production but side effects can include liver damage, bleeding in the mouth, birth defects, and even suicide. Laser treatments can't reach the skin's deep sebaceous glands


Still, Dr. Shah cautions the treatment isn't for everyone. He says most teen-agers won't need the procedure because their skin will clear up with time anyway. "I only treat patients over 20-years-old," he says. "Their hormonal changes are likely permanent. For them Botox is now the safest most effective treatment we have."


"I'd definitely recommend this to anyone else," says Sanjay "I've gone almost a year without breaking out. You have no idea how good that feels."




[1] Use of intradermal botulinum toxin to reduce sebum production and facial pore size.
Shah, Anil R.,Journal of Drugs in Dermatology 9/1/08
accessmylibrary/coms2/summary_0286-36907084_ITM


Source
Dr Michael Breen Associates


View drug information on Botox Cosmetic.

World Psoriasis Day Supplement Available On EPG Patient Direct

EPG Health Media this week launched a 'World Psoriasis Day' supplement on its public health website epgpatientdirect. The temporary feature is intended to raise awareness of the annual international event, which was held this year on Wednesday 29th October.


World Psoriasis Day was launched in 2004, when a number of organisations came together to arrange global events aimed at raising the profile of psoriasis in the health sector and society generally, while reassuring sufferers that they are not alone as they cope with psoriasis in their daily lives. The event is presented each year by the International Federation of Psoriasis Associations (IFPA), which is comprised of member psoriasis organisations from around the world.


EPG Patient Direct's 'World Psoriasis Day' feature supplements it's Psoriasis Quick Guide; an interactive educational resource containing an overview of psoriasis, its causes, symptoms and treatment options. EPG Patient Direct is a 'one-stop' health portal providing the general public in Europe with information on a broad range of health issues. In addition to its condition-specific 'Quick Guides', the website contains daily health news and links to support groups.


In support of this yea's World Psoriasis Day event, the EPG Patient Direct website has included links to patient organisations, web forums, interviews with psoriasis sufferers, news articles and an interactive public poll. The day's main events, which were organised by participating member organisations, are listed by country.


"Psoriasis is a serious and debilitating skin condition affecting 125 million people around the world, however many people are unaware that it can have a profound affect on the quality of life of sufferers, both physically and emotionally" said Chris Cooper, EPG Health Media. "By covering the World Psoriasis Day activities on our patient website, we join together with other organisations hoping to empower psoriasis sufferers with the information and courage they need to seek the best possible support for themselves and fellow sufferers".


For further information about the EPG Patient Direct website, its content and partners, visit epgpatientdirect


About EPG Health Media


EPG Health Media is owned by UK based IMR International Ltd, a private limited Company specialising in the delivery of e-communication and clinical information solutions. The Company's activities fall within three key areas of competency; electronic publishing, e-Marketing/Communications Solutions and market research.


Source

Charlotte Batten

EPG Health Media Public Relations

epghealthmedia

Research Looks For Sunburn Treatment

Researchers are giving people a tan in a bid to find a treatment for sunburn.


A research team led by Dr Anna Nicolaou, a Reader in Biological Chemistry at the University of Bradford, will examine the biological mechanisms underlying sunburn and why it particularly affects people who tan poorly.


It is hoped that the research could conclude in a treatment for sunburn and other skin disorders that are affected by solar radiation, including skin cancer.


With a ?230,000 grant from the Wellcome Trust, the research team will test whether melanocytes that do not actively produce melanin (a substance produced by certain skin cells called melanocytes) discharge inflammatory mediators, including pro-inflammatory hormones called prostaglandins, which cause the redness, irritation and swelling of the skin that is observed in sunburn.


The team will also look at why people who tan easily are less likely to develop sunburn, contrasting to pale-skinned people who tend to sunburn easier.


They will look at whether or not melanocortins (hormones discharged from the anterior pituitary gland that control the production of melanin by melanocytes) play a significant role in the relationship between tanning and sunburn by stimulating melanin production and inhibiting prostaglandin production.


Dr Nicolaou is leading teams of researchers form the Universities of Bradford, Manchester and Newcastle who will experiment on volunteers using artificial sunlight to establish how quick volunteers are affected by sunlight and sunburn.


Cells taken from the volunteers after they have been exposed to artificial sunlight will be monitored and placed under different types of conditions. Prostaglandins and other similar mediators produced by the cells under all these conditions will be studied in detail using the state-of-the-art mass spectrometry facilities at the University of Bradford's Analytical Centre.


The results of these studies will help determine the effects of sunlight on different types of skin and this way discover the mechanism that links sunburn and tanning.


Dr Nicolaou said: "We hope that our research will confirm that melanocytes are involved in many functions of the skin biology and have many other important effects other than tanning. There is a good possibility that we may develop a therapy that can prevent or treat sunburn at its early stages.


"We also hope that this research will confirm that people with paler skin will never tan, no matter how hard they try.


"People put their skin through such bad treatment in the hot weather in order to get a tan. Hopefully our research will convince people to look after their skin and protect themselves from harmful rays."


BRADFORD UNIVERSITY


BRADFORD UNIVERSITY

Bradford

West Yorkshire

BD7 1DP

bradford.ac.uk

FDA: Serious Side Effects From Swallowing Topical Benadryl Product

The U.S. Food and Drug Administration is warning consumers about potentially serious side effects from mistakenly swallowing Benadryl Extra Strength Itch Stopping Gel, an over-the-counter (OTC) product that should only be used on the skin.


The FDA has received reports of serious side effects in people who have mistakenly swallowed the product. Some OTC Benadryl products are intended to be swallowed. However, Benadryl Extra Strength Itch Stopping Gel is only safe and effective when used, as directed, on the skin. People swallowing the gel can ingest a dangerous amount of the active ingredient, diphenhydramine. Large doses of diphenhydramine can result in serious side effects such as unconsciousness, hallucinations, and confusion.


"Consumer confusion and incorrect product use are serious public health issues," said Carol Holquist, R.Ph., director of FDA's Division of Medication Error Prevention and Analysis. "FDA is advising consumers and pharmacies to store products for the skin separately from products that should be swallowed."


Many pharmacies and grocery stores sell diphenhydramine topical gels that look very similar in packaging to Benadryl Extra Strength Itch Stopping Gel. It is important that consumers also avoid swallowing these products.


To help consumers recognize that Benadryl Extra Strength Itch Stopping Gelis meant for use on the skin, the manufacturer, Johnson and Johnson, has taken the following actions:


- Changed the product label to add a new, prominent statement "For Skin Use Only."

- Attached a sticker to the cap of the product that says "For Skin Use Only."

- Initiated consumer studies to better understand factors that may contribute to consumers mistakenly swallowing Benadryl Extra Strength Itch Stopping Gel.


The FDA encourages manufacturers of similar products to adopt similar changes to their labeling and packaging.


The repackaged product is currently stocked in retail stores. The FDA reminds consumers and health care professionals to always read the "Drug Facts" box to identify active ingredients, directions for use, and warnings before using any OTC drug product.


Consumers and health care professionals are encouraged to report adverse side effects to the FDA's MedWatch Adverse Event Reporting program at fda/MedWatch 1or by calling 800-332-1088.


For more information


FDA 101: Medication Errors

Source
U.S. Food and Drug Administration

Keeping Herpes Infection In Check: Pitt School Of Medicine Researchers Describe Immune System Strategies In Science Paper

Herpes simplex virus type I can cause bouts of cold sores, blindness and potentially lethal encephalitis when it reawakens from a quiescent state in the nerve cells it infects.


To prevent these consequences, the stealthy virus is kept under constant guard by the immune system, say University of Pittsburgh scientists. Their research challenges the once common notion that latent HSV-1 in sensory neurons is invisible to the immune system.


Actually, immune cells keep the infection under close surveillance, actively holding HSV-1 in check without destroying the neurons harboring it, said Robert L. Hendricks, Ph.D., Joseph F. Novak professor and vice-chair for research in the Department of Ophthalmology and professor in the Departments of Immunology and Molecular Microbiology and Genetics at the University of Pittsburgh School of Medicine. Sensory neurons may not regenerate, so an immune system attack that destroys them could do more harm than good.


In a paper published in the October 10 issue of Science, teams led by Dr. Hendricks and Paul R. Kinchington, Ph.D., also a professor in the University of Pittsburgh School of Medicine Department of Ophthalmology, show one way this balancing act is carried out.


Immune cells called CD8 T cells attack virus-infected cells with lytic granules, which are packets of potentially toxic enzymes. Transport of lytic granule contents into infected cells typically initiates a process that leads to a form of cellular suicide called apoptosis.


However, according to the researchers' experiments, that isn't the case when CD8 T cells target infected sensory neurons.


"Instead, the lytic granules attack the viral infection in neurons without killing them," explained Dr. Hendricks, senior author. "One way is through a lytic granule enzyme called granzyme B, which cleaves an important HSV-1 protein required for viral replication. That means the neuron and the virus survive, but the infection can't spread to other cells."


Recurrences of cold sores, eye disease and other forms of herpetic lesions occur if the balance shifts and the virus can bypass surveillance by the immune system.


Dr. Hendricks noted that up to 90 percent of people eventually become infected with HSV-1, many in childhood. The initial infection typically produces mild symptoms or none at all, but the virus remains in the neurons for a lifetime, occasionally waking up to cause disease. It repeatedly scars the cornea when this occurs in the eye, making HSV-1 a leading infectious cause of blindness.


Previous studies showed CD8 T cells can use interferon-gamma to block reactivation without killing the neuron, but only some sets of neurons are controlled in this manner, Dr. Hendricks said. His team will continue to try to identify how immune cells, HSV-1 and neurons interact, which could have implications for treatment and vaccine development for HSV-1 infections, as well as for gene therapy applications that use harmless versions of the herpes virus as a vector to ferry treatment genes into cells.


The paper's lead author is Jared E. Knickelbein, Ph.D., and coauthors include Michael B. Yee, B.S., Catherine J. Baty, D.V.M., Ph.D., all of the University of Pittsburgh School of Medicine, and Kamal M. Khanna, Ph.D., University of Connecticut.


The research was supported by the Eye and Ear Foundation of Pittsburgh, New York- based Research to Prevent Blindness and the National Eye Institute.


The University of Pittsburgh School of Medicine is one of the nation's leading medical schools, renowned for its curriculum that emphasizes both the science and humanity of medicine and its remarkable growth in National Institutes of Health (NIH) grant support, which has more than doubled since 1998. For fiscal year 2006, the University ranked sixth out of more than 3,000 entities receiving NIH support with respect to the research grants awarded to its faculty. As one of the university's six Schools of the Health Sciences, the School of Medicine is the academic partner to the University of Pittsburgh Medical Center. Their combined mission is to train tomorrow's health care specialists and biomedical scientists, engage in groundbreaking research that will advance understanding of the causes and treatments of disease and participate in the delivery of outstanding patient care.


University of Pittsburgh Medical Center

Autoantibodies Complement Mast Cells In Bullous Phemphigoid, Skin Disorder Of The Elderly

Bullous pemphigoid (BP) is a skin disorder of the elderly that is characterized by the presence of fluid-filled blisters on the skin. Individuals with BP have large amounts of antibodies that recognize two of the individual's own proteins (BP180 and BP230), but exactly how these antibodies cause disease has not be determined. Now, in a study using a mouse model of BP, which appears online on October 5 in advance of publication in the November print issue of the Journal of Clinical Investigation, researchers from the University of North Carolina, have shown that these antibodies activate an immune system pathway known as the classical complement pathway.



Transfer of antibodies specific for mouse BP180 to other mice induces the formation of blisters similar to those seen in individuals with BP. However, Zhi Liu and colleagues found that these antibodies do not cause disease in mice lacking C4 (a crucial component of the classical complement pathway). In the absence of activation of the classical complement pathway, immune cells known as mast cells were not activated and neutrophils (another immune cell type) were not recruited to the skin. This study identifies a mechanism by which self-reactive antibodies can cause blister formation in mice, and might lead to new treatments for individuals with BP and other autoimmune blistering diseases, such as herpes gestationis -- which is a nonviral disease of pregnancy.



TITLE: Role of different pathways of the complement cascade in experimental bullous pemphigoid



AUTHOR CONTACT:



Zhi Liu

University of North Carolina, Chapel Hill, North Carolina, USA.



View the PDF of this article at: https://the-jci/article.php?id=17891





JCI table of contents: Oct. 5, 2006



Contact: Karen Honey


Journal of Clinical Investigation

Molecular Insight Pharmaceuticals Advances Solazed(TM) For Malignant Melanoma Into Phase 1 Clinical Trial

Molecular Insight Pharmaceuticals, Inc. (NASDAQ: MIPI) today announced the initiation of a Phase 1 clinical trial of Solazed™ (Ioflubenzamide I-131), the Company's targeted radiotherapeutic drug candidate for treatment of malignant metastatic melanoma. The Phase 1 proof-of-concept study is being conducted with the University of Pennsylvania and is funded by a two-year grant from the National Cancer Institute that could total as much as $1.5 million to support this stage of development of Solazed.


"Solazed is our fifth product candidate to enter the clinic, demonstrating our leadership in the development of molecular imaging and targeted radiotherapy of cancer," said Daniel L. Peters, President and CEO of Molecular Insight. "We are hopeful that Solazed will offer a much-needed therapeutic option for patients with metastatic melanoma, a form of cancer known to be exceptionally difficult to treat and associated with a high level of morbidity and mortality."


"Targeting receptors over-expressed in cancers with radioactive payloads has the potential to be highly effective in both the in vivo detection and therapy of cancers," said Chaitanya R. Divgi, M.D., Professor of Radiology and Chief, Nuclear Medicine and Clinical Molecular Imaging Section, University of Pennsylvania. "If fruitful, this method could fulfill an unmet need in melanoma, an aggressive cancer with few current effective therapies."


Solazed, a proprietary radiolabeled small molecule, was designed to bind to melanin found in melanomas and deliver a targeted and lethal dose of radiation to cancer cells through the radioactive decay of iodine-131. Melanin is a naturally occurring pigment that is over-expressed in about half of all melanoma tumors. The Phase 1 clinical trial is designed to define the pharmacokinetics, normal organ distribution and radiation dosimetry of Solazed, and confirm localization in human melanomas. Researchers will image the distribution of Solazed in 12 patients with confirmed metastatic melanoma. Data from this study will inform the design of subsequent therapeutic dose-ranging studies.


In a nonclinical mouse model of human melanoma, Solazed administered in single or multiple doses significantly reduced tumor volumes for a prolonged period of time and enhanced survival compared to control groups treated with standard chemotherapy. In preclinical safety studies the compound exhibited an acceptable toxicity profile. Solazed was granted Orphan Drug status by the Food and Drug Administration for the treatment of stage 2B-4 metastatic melanoma in September 2008.


About Metastatic Melanoma


The incidence of malignant melanoma is rising faster than that of any other cancer in the United States. According to the American Cancer Society, approximately 70,000 cases of melanoma were expected to be diagnosed in the United States in 2009 alone. Although the prognosis depends on the stage of cancer when diagnosed, effective treatment for metastatic melanoma represents a significant challenge for oncologists. Survival rates for advanced melanoma can range from five to 11 months. The rising incidence of malignant melanomas, the early and widespread occurrence of metastases and the poor response rate to current therapies have created a substantial need for new treatments.


Source

Molecular Insight Pharmaceuticals, Inc.

Study Sheds Light On Deadly Lung Disease

Systemic sclerosis (SSc), also known as scleroderma, is characterized by the formation of fibrosis, or scar tissue, on internal organs as well as the skin. Beyond its disfiguring symptoms, SSc is associated with a high rate of deadly lung disease. Pulmonary fibrosis strikes at least one-third of SSc sufferers, and kills 30 percent within 10 years. Assessing and treating SSc remains challenging, despite recent clinical trials, due in part to an incomplete understanding of the origins and progression of this autoimmune disorder.



To add to the understanding of SSc, particularly as it relates to lung fibrosis, researchers with the Royal Free and University College Medical School and Royal Brompton Hospital in London conducted experiments on a novel mouse model of scleroderma. Their results, published in the April 2008 issue of Arthritis & Rheumatism (interscience.wiley/journal/arthritis), provide insight into extreme vulnerability to fibrosis associated with injury to alveolar epithelial cells (AECs) - cells that line the tiny air sacs in the lungs - aggravated by the expression of a major immune-system player, transforming growth factor ?? (TGF ??).



Led by Dr. Christopher P. Denton, the researchers generated a transgenic mouse strain, which develops ubiquitous skin and sporadic lung scar tissue - characteristics similar to humans with SSc and pulmonary fibrosis. They then set out to test their hypothesis that these transgenic mice would be more susceptible than wild-type mice to lung disease. To induce minor lung injury, a single dose of either saline or the antibiotic bleomycin - a widely accepted model of SSc skin fibrosis - was administered surgically to populations of both transgenic and wild-type mice. Representatives from each mouse strain were left untreated to serve as controls. After 3, 7, 10, 14, 21, 35, and 60 days, lung samples were dissected and preserved for biochemical, histological, and electron microscopic analysis.



Transgenic mice consistently demonstrated an exaggerated fibrosis-proliferation response to minor lung injury. The lungs from transgenic mice given normal, unbuffered saline demonstrated fibrotic traits similar to lungs from wild-type mice injected with fibrosis-inducing bleomycin, indicating a very low threshold for epithelial injury in the transgenic strain. Among other notable findings, electron microscopy revealed AEC abnormalities in the lungs of transgenic controls and bleomycin-affected wild-type mice; the lungs of transgenic mice given bleomycin showed severe epithelial damage. The level of collagen was elevated in the lungs from transgenic mice after doses of either bleomycin or saline. After injury with bleomycin, the lungs of transgenic mice demonstrated increased density of the TGF ?? protein, implicated in the formation of fibrosis as well as tissue inflammation. Persistent fibrosis in transgenic mice injured with bleomycin was found independent of inflammation, but associated with impaired alveolar epithelial repair.



"These results suggest that in the context of fibroblast-specific perturbation of TGF ?? signaling, even minor epithelial injury induces significant fibrosis," Dr. Denton concludes. "The model supports a central role for TGF ?? in determining fibrosis and demonstrates that lung fibroblasts may regulate the response of AECs to injury."



Despite its limitations, including the fact that animal models with targeted genetic manipulations cannot fully represent all the facets and factors in the associated human disease process, this novel mouse study contributes to the understanding of the pathogenesis of systemic sclerosis and pulmonary fibrosis. What's more, it provides a valuable reference point and motivation for future studies into anti-fibrotic therapies.

European Medicines Agency Recommends New Contraindication And Warning For Rasilez And Other Aliskiren Medicines

The European Medicines Agency (EMEA) has recommended adding a
contra-indication to the Product Information for aliskiren, stating that
it must not be used in patients who have experienced angioedema
(swelling of the tissues beneath the skin) when taking aliskiren in the
past. The Agency also recommended the inclusion of a warning, stating
that patients who develop signs of angioedema should stop treatment and
seek medical attention.


Aliskiren is authorised for the treatment of essential hypertension
(high blood pressure with no identifiable cause). It has been authorized
in the European Union (EU) since August 2007 as Rasilez, Enviage,
Sprimeo, Tekturna and Riprazo.


Angioedema is characterised by swelling of the skin, the tissues below
the skin and the moist body surfaces such as the lining of the mouth and
throat. It can develop rapidly and in rare cases can be dangerous if it
affects the throat, because it can lead to obstruction of the airway.


Cases of angioedema or similar reactions were reported with
aliskiren-containing medicines. Following assessment of all available
evidence, the EMEA's Committee for Medicinal Products for Human Use
(CHMP) concluded that the benefits of aliskiren-containing medicines in
the treatment of essential hypertension continue to outweigh their
risks, but that angioedema can occur as a rare and serious side effect
with these medicines.


The Committee is therefore recommending that:
* healthcare professionals should not prescribe any aliskiren-containing
medicines for patients who have developed angioedema with the
aliskiren-containing medicine in the past;


* any patients who develop signs of angioedema should stop aliskiren
treatment promptly and seek medical attention.


The EMEA's recommendation has been sent to the European Commission for
the adoption of a legally binding decision.


Aliskiren is also authorised in combination with hydrochlorothiazide as
Rasilez HCT. The Product Information for this medicine already contains
this contraindication and warning.


Notes


1. The active substance in Rasilez, aliskiren, is a renin inhibitor. It
blocks the activity of a human enzyme called renin, which is involved in
the production of a substance, angiotensin I, in the body. Angiotensin I
is converted into the hormone angiotensin II, which is a powerful
vasoconstrictor (it narrows blood vessels). By blocking the production
of angiotensin I, levels of both angiotensin I and angiotensin II fall.
This causes vasodilation (widening of the blood vessels), so that the
blood pressure drops and the potential risk of damage caused by high
blood pressure may be reduced.


2. In the EU, Rasilez is marketed in Austria, Belgium, Cyprus, Denmark,
Finland, Greece, Germany, Ireland, Iceland, Luxembourg, Malta, Norway,
the Netherlands, Poland, Spain, Slovakia, Sweden and the United Kingdom.
The other aliskiren-containing medicines have not been launched.


3. More information about Rasilez is available in the European public
assessment report here.



4. This press release, together with other information on the work of
the EMEA, can be found on the EMEA website: emea.europa.eu


EMEA


View drug information on Tekturna.

What's The Skinny On Fat Removal? Dermatologists Believe Emerging Non-Invasive Technologies Shaping Up To Be The Next Big Thing

For many people, diet and exercise help keep them looking and feeling healthy. But even those who work hard on staying in shape might have a hard time shaking stubborn love handles or lower belly fat, which can bulge through clothing like a neon sign. While the market for getting rid of unwanted fat has grown over the years to include stomach stapling and behavioral techniques, there is still a demand for procedures that can reduce areas of localized fat safely and effectively.


Speaking today at the American Academy of Dermatology's SKIN academy (Academy), Chestnut Hill, Mass., dermatologist Jeffrey S. Dover, MD, FAAD, associate clinical professor of dermatology at Yale University School of Medicine in New Haven, Conn., and adjunct professor of medicine (dermatology) at Dartmouth Medical School in Hanover, N.H., presented the latest non-invasive technologies being studied to target fat and how these new procedures soon could help people of average weight who struggle with localized areas of fat.


"There is a strong demand for non-invasive procedures that can address the concerns of people who are not considered overweight, but despite diet and exercise, have pockets of fat that bother them," said Dr. Dover. "While traditional liposuction and laser liposuction are invasive surgical procedures that are designed for overall fat reduction, new procedures are emerging that are non-invasive and are showing promise in clinical studies for removing fat without the potential risks and downtime of invasive procedures."


Best Candidates Are Near Their Ideal Body Weight


Dr. Dover stressed that the new procedures under development that target fat are not intended as a weight-reduction program for overweight individuals who would require therapies designed for overall fat reduction. Instead, the best candidates for one of the newer fat removal procedures are people near their ideal body weight who eat well and exercise regularly and have pockets of fat that have not responded to a healthy lifestyle. For example, these areas of fat include the lower belly (from pregnancy), love handles, back fat, saddle bags, and fat under the chin.


While there are several different approaches for non-surgical fat removal, Dr. Dover explained that this field is still in its infancy and many of these techniques are not approved by the U.S. Food and Drug Administration (FDA). However, studies are demonstrating that fat pockets can be removed without damaging the overlying skin - making these innovative procedures inherently safer by design.


Ultrasound Uses Sound Waves to Selectively Destroy Fat


Considered a promising new technique for fat removal, ultrasound technology uses focused, pulsed waves of non-thermal ultrasound energy (sound waves) to "shake" and selectively destroy fat beneath the skin without harming the skin or surrounding tissues. There are two different types of high-frequency ultrasound procedures undergoing FDA-monitored studies in the U.S. - focused ultrasound and high-intensity focused ultrasound. While focused ultrasound is a lower-energy device that is a comfortable procedure, high-intensity focused ultrasound delivers much higher energy levels and can be painful.















Data from collective clinical studies that used focused ultrasound for abdominal fat removal on more than 600 patients over the past five years concluded that 94 percent of patients experienced a measurable circumference reduction in the treatment area, with 90 percent of patients being satisfied with the treatment. Based on these studies, the average circumference reduction reported ranged from 3.5 to 6.3 centimeters with an overall average of 4.4 centimeters. These measurements are very difficult to make accurately and may overstate the actual reduction. Dr. Dover noted that for three years of these collective studies, patients received three treatments spaced two weeks apart. Prior to this time, only one treatment was administered.


With the high-intensity focused ultrasound system (which also is not approved for sale or use in the U.S. but has been used in Europe as a cosmetic device since 2008), high-intensity ultrasound energy is focused at precise depths within the fat tissue. This energy thermally dissolves the fat, without harming the skin or underlying tissues and organs.


Dr. Dover stressed that with both ultrasound procedures, results are not immediate and it takes several weeks to see a noticeable improvement in fat reduction in the treated area.


"Although ultrasound technology is still being tested and its effectiveness is limited to early studies, it offers a unique approach to combating localized fat without invasive surgery," said Dr. Dover. "In time, I think it will be a viable option for people who want to target specific areas of fat, such as belly fat."


Cryolypolysis Freezes Fat Cells to Dissolve Them


Another promising new fat removal technology, cryolypolysis uses an innovative approach of freezing fat cells in order to dissolve them. Dr. Dover explained that since fat cells are more sensitive to cold temperatures than other skin cells, they can be altered more easily when targeted with cold rather than with heat. Currently approved by the FDA for chilling the skin, cryolypolysis is not yet approved for body contouring, body shaping or fat reduction.


Cryolypolysis works by freezing the fat beneath the skin, which causes selective crystallization of lipids in fat cells that slowly dissolve without injuring any surrounding tissues. Since fat cell death occurs gradually, there is no trauma or immediate "bursting" of fat cells that can be caused by methods that use heat to destroy fat cells. For this reason, results are not immediate and fat layer reduction becomes visible gradually over the course of two to six months.


In the first human study that used cryolypolysis to treat 32 subjects with love handles, Dr. Dover (the study's lead investigator) treated love handles on one side of the body with cryolypolysis and used the love handles on the opposite side of the body as the control. Four months after the procedure, the majority of subjects experienced a noticeable change in fat reduction in the treated love handle. In addition, Dr. Dover explained that ultrasound measurements taken on 10 of the 32 subjects showed an average fat layer reduction of 22.4 percent in all of these subjects four months after the procedure.


"Based on our early findings, cryolypolysis is a very exciting new approach for the non-invasive removal of localized fat in the belly, love handles, back and saddle bags of the thighs," said Dr. Dover. "Although this technology is still being developed, I think with further clinical testing cryolypolysis eventually could be expanded for use in other areas prone to excess fat, such as the neck, knees and arms."


As mentioned, results in fat layer reduction with cryolypolysis are not immediate. Side effects are limited to slight discomfort, numbness and redness for an hour or two post-treatment, as well as some change in skin sensation in the treated area for up to two to three weeks.


Dr. Dover further explained that for all of the non-invasive technologies studied to date, the research has not shown that the body's blood lipid profile changed after any of the treatments. "This finding is important, as it suggests that these procedures are safe," said Dr. Dover. "While we're not sure where the dissolved fat goes once it is dissolved, we think it gently goes into the bloodstream and that the body is able to absorb and process it in the liver."


Given the recent expansion of clinical research designed to fine tune these non-invasive fat removal technologies and strong consumer interest in procedures that require little downtime, Dr. Dover estimates that this market will expand and consumer options will increase in the next five years.


Headquartered in Schaumburg, Ill., the American Academy of Dermatology (Academy), founded in 1938, is the largest, most influential, and most representative of all dermatologic associations. With a membership of more than 16,000 physicians worldwide, the Academy is committed to: advancing the diagnosis and medical, surgical and cosmetic treatment of the skin, hair and nails; advocating high standards in clinical practice, education, and research in dermatology; and supporting and enhancing patient care for a lifetime of healthier skin, hair and nails.

PV-10 Treatment For Metastatic Melanoma Well-Tolerated By Patients - Evidence Of "Bystander Effect" Observed In Phase 1 Trial

Provectus Pharmaceuticals, Inc. (OTC BB: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced that the lead investigator for its Phase 2 melanoma study, Professor John F Thompson, MD, today presented clinical data on PV-10 at the "Perspectives in Melanoma XII" meeting at The Hague, The Netherlands. Professor Thompson's presentation was entitled "PV-10 Chemoablation of cutaneous and subcutaneous metastatic melanoma."
Craig Dees, PhD, CEO of Provectus, said, "Our Company is engaged in opening a new front in the war on cancer, and the clinical studies led by Professor Thompson are a major component of that new front. Our phase 1 trial was a great success, and initial results we have from our ongoing phase 2 trial are encouraging."


According to the Phase 1 data presented, PV-10 treatment was well tolerated despite the relatively advanced age of the subjects. In addition, PV-10 appeared to trigger a response in the immune system of a number of subjects, enabling their bodies to attack uninjected melanoma tumors in a process called the 'bystander effect'.


PV-10 is a solution of Rose Bengal (10% RB in saline) that Professor Thompson has been using to treat metastatic melanoma. In the phase 1 study, safety and preliminary efficacy were assessed in 20 subjects with Stage III or IV metastatic melanoma, either on the skin or just beneath it. All subjects received a single treatment of up to 20 lesions, while up to 3 untreated lesions were observed for evidence of the potential bystander effect.


When injected into melanoma tumors, PV-10 appeared to kill the tumors by a process called chemoablation while leaving surrounding healthy tissue undamaged. Thompson found that injected tumors started to die within several days. Complete or partial response was characterized by gradual involution, or shrinking, that appeared to continue for up to 12 weeks or more. Forty percent of subjects achieved an objective response in their injected lesions, with 20% having a complete response (CR) and another 20% having a partial response (PR). An additional 35% experienced stable disease (SD).


Sixteen subjects (80%) completed the minimum 12 weeks of observation, while four withdrew early due to underlying disease progression. The most common adverse events were transient pain at the treatment site (75% of subjects), followed by local inflammation or mild infection (25% of subjects). Only three systemic adverse events were reported (a single instance each of mild insomnia secondary to injection site pain, mild photosensitivity reaction restricted to the injected limb, and Grade 3 photosensitivity reaction).


The expanded phase 2 testing for PV-10 commenced in late 2007, aiming to assess PV-10 chemoablation in 80 Stage III and IV metastatic melanoma subjects - the same condition as in the phase 1 study. Over one third of the patients needed have already been enrolled at centers in Brisbane and Sydney, Australia, and at the M.D. Anderson Cancer Center in Houston, TX. Provectus expects to announce further sites in the U.S. and Australia in the near future. This phase 2 study differs from phase 1 testing in several key ways: new or incompletely responsive lesions may be treated at weeks 8, 12 or 16 after initial PV-10 administration; and follow-up is extended to 52 weeks.















According to the American Cancer Society, more than 62,000 people are expected to be diagnosed in the in the US in 2008 with melanoma, the most serious form of skin cancer, leading over 8,000 deaths this year.


About Perspectives in Melanoma XII


With a wealth of new data in a rapidly evolving field, Perspectives in Melanoma XII is designed to provide a comprehensive overview of recent advances and rigorous discussions of the most current and controversial topics in melanoma clinical research and contemporary therapy. Led by authorities and current investigators in the field, the program covers several of the most promising and important on-going clinical trials. State-of-the-art presentations by experts in molecular biology, genetics, and immunology are designed to provide an educational experience for all melanoma-related disciplines.


For further details visit here.


About Provectus Pharmaceuticals, Inc.


Provectus Pharmaceuticals is a development stage company that specializes in oncology and dermatology therapies that are safer, more effective, less invasive and more economical than conventional therapies. Provectus is currently conducting Phase 2 clinical trials of their proprietary drugs PV-10 as a therapy for metastatic melanoma and PH-10 as a topical treatment for psoriasis and atopic dermatitis. Information about these and the Company's other clinical trials can be found at the NIH registry, clinicaltrials. The Company has received orphan drug designation from the FDA for its melanoma indication. Complementing their suite of proprietary drugs, Provectus has developed a number of intellectual properties and technologies in the areas of imaging, medical devices and biotechnology. For additional information about Provectus please visit the Company's website at pvct or contact Porter, LeVay & Rose, Inc.


Forward-Looking Statements

The forward-looking statements contained herein are subject to certain risks and uncertainties that could cause actual results to differ materially from those reflected in the forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect management's analysis only as of the date hereof. The company undertakes no obligation to publicly revise these forward-looking statements to reflect events or circumstances that arise after the date thereof.


Provectus Pharmaceuticals, Inc

Ultraviolet Light Helps Skin Cancer Cells Thrive, Researchers Report

The sun's ultraviolet light activates an enzyme that helps skin cancer cells survive and proliferate, researchers report.


The finding shows another way cancer pirates normal body functions as it points toward better treatment for the million new cases of non-melanoma skin cancers diagnosed in the United States annually, said Dr. Wendy Bollag, corresponding author of the study in Oncogene. Bollag is a cell physiologist at the Medical College of Georgia and the Charlie Norwood Veterans Affairs Medical Center.


"We are living longer and getting a lot of UV radiation in the process," she said of increasing skin cancer rates. Her research shows that UV's ill effects are cumulative and dose dependent: more UV exposure equals more activity by the enzyme protein kinase D. That's another wakeup call about excess sun exposure particularly as we age, Bollag said, and an indicator that protein kinase D inhibitors, already under development for other cancers, may also work for skin cancer.


Skin cells normally make protein kinase D to help regulate growth needed to replace cells that are constantly sloughing off. "The skin has to continually divide to replace cells that get lost to the environment," Bollag said. Even something as benign as wearing clothes prompts skin cell loss and the constant demand for new ones. "So, protein kinase D is good under normal conditions, when it's regulated appropriately. But what can happen is it starts misbehaving," Bollag said.


Its increased activity enables skin cells to survive the constant onslaught of UV radiation, which can be good or bad. "If the damage caused by UV is relatively minor, so the cell can repair it, that's good. You wouldn't want to walk across the street, your skin gets hit by UV, all the cells die and your skin sloughs off," Bollag said.


The downside is that by promoting cell survival, protein kinase D can enable skin cells with a lot of DNA damage to become cancerous by reducing the natural ability of badly damaged skin cells to self-destruct, the researchers show.


Bollag's laboratory previously found that protein kinase D was upregulated in basal cell carcinoma, a common non-melanoma skin cancer. Since sun exposure is the greatest risk factor for basal cell carcinoma, they suspected the link between ultraviolet radiation and protein kinase D.


Now they also have found that pretreating skin cells with antioxidants appears to reduce protein kinase D activation by UV, indicating that reactive oxygen species, or free radicals, also play a role. Free radicals can result from excessive cell activity or oxygen use.


The researchers want to further explore UV's impact on protein kinase D in the more deadly melanoma cancers. They also want to know if, as with hormones, protein kinase D activity normally slows with age. They suspect it does since skin cell turnover slows with age. But it may just be that aging skin cell repair mechanisms maintain skin cell survival but don't repair the sun's damage as well as they once did, Bollag said.


She notes that some UV radiation is good; it's a great source of vitamin D - important for bone, breast, vascular health and more - which is lacking in many diets. In fact, in some areas of the country, certain types of cancer, such as prostate cancer, are linked to decreased sun exposure.


Non-melanoma skin cancers arise from the keratinocytes, which comprise about 90 percent of skin cells and give skin its primary functions, such as its role as a mechanical barrier. Melanomas occur in the less common melanocytes which give the skin color.


The studies were funded by a Veterans Affairs Merit Award and the National Institute of Arthritis, Musculoskeletal and Skin Diseases.

People use OTC hydrocortisone cream in safe and appropriate amounts

Adults and children generally apply the product that is commonly used to treat these conditions - over-the-counter
hydrocortisone cream (HC) - in safe and appropriate amounts.


Charles N. Ellis, M.D., of the University of Michigan Health System said he was pleasantly surprised by the number of study
participants who complied with the usage guidelines. Ellis is the lead author of the study, which appears early in the online
edition of the Journal of the American Academy of Dermatology.


"The people in the study reported that they're following the label in large part," says Ellis, professor and associate chair
of dermatology in the U-M Medical School, and chief of the Dermatology Service at the Veterans Affairs Ann Arbor Healthcare
System. "Not many of them have used it beyond the suggested amount of time, and not many used it more often than
recommended."


"Our findings suggest that people who use over-the-counter hydrocortisone cream generally do so in a way that is likely to be
safe," he says.


Adults were found to be compliant with the instructions about three-quarters of the time, and they reported following the
recommendations for treating children about as often. The most common way in which people were not compliant with directed
uses was in using the creams to treat cuts. It also was used to treat acne, athlete's foot, arthritis and jock itch, against
the recommendations on the label. HC is not effective in treating these conditions.


The 2,000 study participants were asked in phone interviews if they had used over-the-counter hydrocortisone products such as
Cortaid, Cortizone 10 or other similar products in the past six months. Those who had used OTC hydrocortisone products were
asked questions about their patterns of use. They answered these questions without being able to refer to the product label.



Respondents also were asked if they had any children younger than 18 in the house who had used HC; if so, they were asked
about the use by the youngest child in the past six months.


Respondents who had used hydrocortisone or whose children had used it were asked what conditions they had treated with the
cream and questions about their usage patterns, including the frequency and duration of use. They also were asked if they had
discussed with a doctor their own usage of HC and/or their use of it on the youngest child in the household.


In all, 396 (20 percent) of the adults in the study reported using over-the-counter HC in the previous six months. The most
common conditions they treated with the creams were rashes, insect bites and itchy skin.


Researchers found that when adults were using HC, they did so an average of twice a day, and 98 percent of them used it four
or fewer times a day, which complies with directions for use. That means only 2 percent of adults reported using HC more
times in a day than recommended. In all, when factors such as the type of use and the duration of use were factored in,
almost three-quarters - 73 percent - of adults in the study were compliant with the instructions on the label. One-third of
the adult respondents had discussed the use of topical HC with a doctor. The compliance level rose to 89 percent when the
results were recalculated with the assumption that the doctor had allowed for wider uses and treatment regimens.















In children, HC tended to be used primarily for insect bites, rashes, eczema and itchy skin. Of the 2,000 households,
one-third had a child younger than 18 living at home and a quarter of those reported treating a child with over-the-counter
HC in the previous six months.


The frequency of use was more than the recommended maximum of four times a day in only 3 percent of cases, and only 6 percent
reported using it for longer than the recommended maximum of seven days. More than half (55 percent) of these households
reported talking to a doctor at some time about their child's use of over-the-counter HC.


In all, given the duration and frequency of use, the type of condition treated, and the age of the child, 72 percent of the
use on children followed the recommended usage guidelines. When the figure was recalculated to assume that the physicians who
were consulted had allowed for wider uses and treatment regimens, the compliance level rose to 89 percent.


In addition to Ellis, the other authors on the paper were Michelle D. Ertischek, Janine L. Pillitteri, Ph.D., and Saul
Shiffman, Ph.D. of Pinney Associates; and Theodore K. Kyle, R.Ph., and Steven L. Burton, M.B.A., of GlaxoSmithKline Consumer
Healthcare.


The study was supported by GlaxoSmithKline Consumer Healthcare. Ellis, Pillitteri, Shiffman and Ertischek serve as
consultants to GlaxoSmithKline Consumer Healthcare. Ellis also serves as a consultant to other manufacturers of topical
corticosteroids. GSK does not sell a topical HC but does sell a low-potency prescription-strength topical corticosteroid
(Aclovate).


Reference: Journal of the American Academy of Dermatology


University of Michigan Health System

umich

A Mutation That Restores Health:

Errors in the copying of genes during cell division can cause numerous diseases, including cancer. Yale School of Medicine scientists, however, have unraveled the secrets of a much more rare phenomenon with potential therapeutic implications - disease-causing genes that show a high frequency of self-repair.



In Science Express, the Yale team describes how one mutated copy of a gene called keratin 10 causes a severe skin disease known as ichthyosis with confetti (eurekalert/multimedia/pub/25021.php?from=167265). However, amidst the diseased skin, these patients also have hundreds to thousands of spots of normal skin. This phenomenon, the researchers report, occurs by the recombination of chromosomes prior to cell division. Instead of producing one normal copy of the gene and one dominant, disease-causing mutation, the exchange between chromosomes results in cells with either two mutant copies or no mutant copies. If the latter occurs, spots of normal, disease-free skin will form. The investigators used these recombination events in spots of normal skin to map and ultimately identify the disease gene.



"Usually, you have a disease-causing mutation, and you are stuck with it," said Keith Choate, assistant professor of dermatology and first author of the paper. "But we demonstrate that in this disease, there is an unusually high frequency of the appearance of mutation-free clones of cells." The reason these particular mutations revert to normal so frequently is not clear, note the scientists. However, in all affected patients the normal tail end of the keratin 10 protein is replaced by a protein sequence enriched for one amino acid, arginine. This causes the mutant keratin 10 to end up in the wrong part of the cell. "We believe the mis-localization of keratin 10 contributes both to the severity of the disease and the appearance of the clones of normal skin," said Richard Lifton, senior author of the paper and Sterling Professor and chair of the department of genetics.



The researchers say that knowing that these particular mutations can revert with high frequency gives them hope that they might find a way to mimic this process to develop treatments for other genetic diseases.



"Perhaps rather than directly correcting disease-causing mutations we might be able to recombine them away, similar to what happens in this disease," said Leonard Milstone, emeritus professor of dermatology and member of the research team.



Notes:

Researchers at the University of California, San Francisco, Children's Mercy Hospitals and Clinics and Texas Children's Hospital contributed to the study. Other Yale authors on the paper are Yin Lu, Jing Zhou, Murim Choi, Anita Farhi and Carol Nelson-Williams,


The work was funded by the NIH and the Howard Hughes Medical Institute.

HairDX Genetic Hair Loss Tests Now Available In Mexico At Svenson Hair Centres

The HairDX Genetic test for predicting the risk of male or female hair loss becomes available in Mexico today through a distribution agreement between Global Beauty International (HK) Limited (GBIL) and genetic dermatology research and development innovator DermaGenoma, Inc.


Global Beauty International will introduce the genetic test to all Svenson Hair Centres in Mexico. HairDX's easy to use test provides an understandable genetic analysis of a man's or woman's likelihood of developing Androgenetic Alopecia, the most common type of hair loss.


"This test adds a vital new element to our professional diagnostic capabilities in Mexico," says Dr. Katia Delgado. Only when the real cause of a client's hair loss is determined can an effective tailor-made treatment program begin. HairDX helps determine a genetic susceptibility to hair loss before thinning or receding hair becomes apparent."


Dr. Delgado says that men or women worried about losing hair can come to Svenson for a simple, confidential predictive test. "As a worldwide leader in the fight against hair loss, at the forefront of using the latest technology to enhance the accuracy of diagnosis and treatment efficacy, Svenson is delighted to bring HairDX to Mexico."


"We're pleased to expand the DermaGenoma global leadership in dermatologic genetics test to Mexico through our partnership with Global Beauty International. It brings the latest in genetic science to men and women concerned about their susceptibility to hair loss," says DermaGenoma CEO Any Goren.

Jefferson Researchers Identify Mechanism Behind Fibrotic Disorder

Scientists from the Jefferson Institute of Molecular Medicine of Thomas Jefferson University are now several steps closer to understanding the mechanism behind a novel systemic fibrotic disorder that affects some patients with renal insufficiency who receive imaging contrast agents for MRI. Two of their studies on the disorder appear together in the November issue of the Annals of Rheumatic Diseases.


Nephrogenic systemic fibrosis (NSF) is a new disease that was first described in 2000. It manifests as progressive fibrosis (thickening of the skin and development of scar tissue) in feet, legs, thighs, hands and forearms. Though initially thought to affect only the skin, it has been shown that NSF can also affect internal organs, including the liver, lungs, muscles, heart, thyroid and dura mater. The disease appears to affect patients with renal failure who receive certain gadolinium-based imaging agents for MRI.


In the first study, the researchers performed cell cultures on fibroblasts - cells that produce collagen - obtained from affected skin taken from patients with NSF. They found that the fibroblasts from these tissues were continually activated, and expressed an increased amount of collagen and other fibrotic proteins, according to Sergio A. Jimenez, M.D., professor of Dermatology and Cutaneous Biology at Jefferson Medical College of Thomas Jefferson University, and Co-Director of the Jefferson Institute of Molecular Medicine.


"We also found that the fibroblasts express large amounts of another protein called smooth muscle actin, which indicates that they have transformed to myofibroblasts, which are cells that are a step between fibroblasts and smooth muscle cells," said Dr. Jimenez, who is also director of the Division of Connective Tissue Diseases and director of the Scleroderma Center at Jefferson. "Smooth muscle actin is a protein that is normally present in smooth muscle cells. But these are not muscle cells, they are fibroblasts. Somehow the fibroblasts have changed their features to become an aggressive smooth muscle-like cell that produces large amounts of collagen."


An important observation was that the activated features of the fibroblasts were maintained in culture for several generations, indicating that the change in the features of these cells was long-lasting, and was probably imprinted in their genetic material.


In a second experiment, Dr. Jimenez and colleagues treated normal fibroblasts with several compounds containing gadolinium, the most commonly used imaging agent used for MRI. They found that these agents induced exaggerated production of collagen in the normal fibroblasts.


"Normal people excrete gadolinium containing contrast agents rapidly, but the chemical can stay in the body for prolonged periods of time in people with renal disease," Dr. Jimenez said.


In the second study, the researchers examined the effects of gadolinium on gene expression of macrophages (white blood cells), production of pro-inflammatory chemicals called chemokines, and activation of a protein complex (NF-kappaB) that regulates immune response. They found that gadolinium-contrast agents caused a profound change in activation of these chemicals and proteins, concluding that these alterations may play a crucial role in development of NSF.


"These studies help us understand why certain gadolinium-containing compounds cause the severe clinical manifestations of NSF, and support the need to develop new MRI contrast materials that are free of this potentially fatal side effect," Dr. Jimenez said. "At the same time, we have also learned some clues about other disorders that are characterized by excessive fibrosis, like scleroderma, which has many similarities."


The studies were funded by a grant from the National Institute of Arthritis, Musculoskeletal and Skin Diseases (National Institute of Health) and by an Investigator Initiated Grant from GE-Healthcare.

Genes And Leprosy Susceptibility

In the first genome-wide association study (GWAS) of leprosy and the largest GWAS on an infectious disease, scientists at the Genome Institute of Singapore (GIS) and 26 institutes in China identified seven genes that increase an individual's susceptibility to leprosy.



The discovery of these genes, reported in the 16 Dec. 2009 New England Journal of Medicine, highlights the important role of the innate immune response in the development of leprosy, said the scientists, who analyzed over 10,000 samples from leprosy patients and healthy controls in China.



"Though leprosy is not common, the discoveries have significant ramifications for chronic infectious disorders and for host-pathogen interactions in other more prevalent mycobacterial diseases such as tuberculosis, said Edison Liu, M.D., Executive Director of GIS, one of the research institutes sponsored by Singapore's Agency for Science, Technology and Research (A*STAR).



"This study represents one of the largest and best organized studies of the host genetics in infectious diseases published," added Dr. Liu.



An immunologist who was not one of the authors of the NEJM paper, Tom H. M. Ottenhoff, M.D., Ph.D., of Leiden University Medical Center in The Netherlands, said,



"This is a very impressive study, which uncovers entirely new genes that control susceptibility to leprosy and perhaps also other related diseases. A great asset is that the study underpins the genetic data with plausible functional biology experimentation, which is not often seen."



Dr. Ottenhoff is Professor in Immunology, Head group Immunology and Immunogenetics of Bacterial Infectious Diseases, at Leiden University Medical Center.



The seven genes associated with susceptibility to leprosy are: CCDC122, C13orf31, NOD2, TNFSF15, HLA-DR, RIPK2 and LRRK2.



"This is a very significant find, and one that can only be achieved through large-scale genetic studies, with close collaborative efforts among multi-disciplinary research groups, often across different countries," said Jianjun Liu, Ph.D., Human Genetics Group Leader at the GIS.



"The discovery of these genes is a major breakthrough for research in leprosy and infectious diseases in general, and will be significant in the early diagnosis and development of new treatments," added Dr. Liu.



In addition to Dr. Liu, the leaders of the GWAS on leprosy included: Fu-Ren Zhang, M.D., Ph.D., of Shandong Provincial Institute of Dermatology and Venereology, and Xue-jun Zhang, M.D., Ph.D., of Institute of Dermatology and Department of Dermatology at No.1 Hospital, Anhui Medical University, China.



GIS Executive Director Dr. Liu noted, , "This is a continuation of a number of deep collaborative studies between the GIS and Chinese scientists in using population sciences to uncover genetic modifiers of human disease. The strength of Chinese clinical sciences and of Singapore's targeted genomic capabilities makes a powerful scientific combination. The key to this collaboration and one that was recently published on the genetics of Asian migration is that the studies were initiated and executed by Asian partners acting as equals. Hopefully, this will initiate a new phase of cooperation between historically competing Asian countries whose primary links have been with western communities."
















Leprosy, a chronic infectious disease caused by the bacterium Mycobacterium leprae (M. leprae), mainly affects skin and peripheral nerves and may lead to irreversible disabilities. Although it has been largely eliminated in developed countries, leprosy is still a major public health problem in many developing countries, particularly in tropic and sub-tropic regions. According to the World Health Organization, 254,525 new cases of leprosy were diagnosed in 2007. Although many people are potentially exposed to M. leprae in endemic regions, only a small minority will be infected and will develop clinically overt leprosy, suggesting that only some individuals are susceptible to this disease.



Because M. leprae cannot be cultured in the laboratory, and because it only infects humans and the Armadillo, research and thus the biological understanding of leprosy are very limited. The discovery of the seven susceptibility genes not only improves scientists' understanding about genetic susceptibility to the disease, but also may stimulate additional biological and clinical research to reveal the mechanism of leprosy development.



Authors of the NEJM paper, "Genomewide association study of leprosy":



Fu-Ren Zhang, M.D., Ph.D., Wei Huang, Ph.D., Shu-Min Chen, M.D., Ph.D., Liang-Dan Sun, M.D., Ph.D., Hong Liu, M.D., Yi Li, Ph.D., Yong Cui, M.D., Ph.D., Xiao-Xiao Yan, M.D., Hai-Tao Yang, M.D., Rong-De Yang, M.D., Tong-Sheng Chu, M.D., Chi Zhang, M.D., Lin Zhang, M.D., Jian-Wen Han, M.D., Gong-Qi Yu, B.S., Cheng Quan, M.D., Yong-Xiang Yu, B.S., Zheng Zhang, M.D., Ben-Qing Shi, M.D., Lian-Hua Zhang, M.D., Hui Cheng, M.D., Chang-Yuan Wang, M.D., Yan Lin, M.D., Hou-Feng Zheng, M.D., Xi-An Fu, M.D., Xian-Bo Zuo, M.S., Qiang Wang, M.D., Heng Long, M.D., Yi-Ping Sun, M.D., Yi-Lin Cheng, M.S., Hong-Qing Tian, M.D., Fu-Sheng Zhou, B.S., Hua-Xu Liu, M.D., Ph.D., Wen-Sheng Lu, M.D., Su-Min He, M.D., Wen-Li Du, B.S., Min Shen, B.S., Qi-Yi Jin, B.S., Ying Wang, Ph.D., Hui-Qi Low, B.S., Tantoso Erwin, B.S., Ning-Han Yang, B.S., Jin-Yong Li, M.D., Xin Zhao, M.D., Yue-Lin Jiao, M.D., Li-Guo Mao, M.D., Gang Yin, M.D., Zhen-Xia Jiang, M.D., Xiao-Dong Wang, M.D., Jing-Ping Yu, M.D., Zong-Hou Hu, M.D., Cui-Hua Gong, M.D., Yu-Qiang Liu, M.D., Rui-Yu Liu, M.D., De-Min Wang, M.D., Dong Wei, M.D., Jin-Xian Liu, M.D., Wei-Kun Cao, M.D., Hong-Zhong Cao, M.D., Yong-Ping Li, M.D., Wei-Guo Yan, M.D., Shi-Yu Wei, M.D., Kui-Jun Wang, M.D., Martin L. Hibberd, Ph.D., Sen Yang, M.D., Ph.D., Xue-Jun Zhang, M.D., Ph.D., and Jian-Jun Liu, Ph.D.



The authors' affiliations are as follows: Shandong Provincial Institute of Dermatology and Venereology, Shandong Academy of Medical Science, Jinan, Shandong, China (F.R.Z., S.M.C., H.L., X.X.Y., T.S.C., L.Z., G.Q.Y., Y.X.Y., B.Q.S., C.Y.W., Y.L., X.A.F., Y.P.S., H.Q.T., H.X.L., W.L.D., J.J.L.); Institute of Dermatology and Department of Dermatology at No.1 Hospital, Anhui Medical University, Hefei, Anhui, China; The Key Laboratory of Gene Resource Utilization for Severe Diseases, Ministry of Education and Anhui Province, Hefei, Anhui, China (L.D.S., Y.C., S.Y., C.Z., J.W.H., C.Q., Z.Z., H.C., H.F.Z., X.B.Z., Y.L.C., F.S.Z., W.S.L., S.M.H., X.J.Z. J.J.L.); Shanghai-MOST Key Laboratory of Health and Disease Genomics, Chinese National Human Genome Center at Shanghai, Shanghai, China (H.W., M.S., Q.Y.J., Y.W.); Genome Institute of Singapore, Singapore (J.J.L., Y.L., H.Q.L., T.E., N.Y., M.L.H.); Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China (Y.H.T., L.H.Z.); Wenshan Institute of Dermatology, Wenshan, Yunnan, China (R.D.Y., H.L.); Anhui Provincial Institute of Dermatology, Hefei, Anhui, China (Q.W.); Weifang Institute of Dermatology, Weifang, Shandong, China (J.Y.L.); Linyi Institute of Dermatology, Linyi, Shandong, China (X.Z.); Yantai Institute of Dermatology, Yantai, Shandong, China (Y.L.J.) Jining Institute of Dermatology, Jining, Shandong, China (L.G..M.); Zaozhuang Institute of Dermatology, Zaozhuang, Shandong, China (G.Y.); Qingdao Center for Disease Control and Prevention, Qingdao, Shandong, China (Z.X.J.); Jinan Institute of Dermatology, Jinan, Shandong, China (X.D.W.); Weihai Center for Disease Control and Prevention (J.P.Y.); Rizhao Institute of Dermatology (Z.H.H); Zibo Center for Disease Control and Prevention (C.H.G.); Qixia County Skin Disease Control Station (Y.Q.L.); Linqu County Skin Disease Control Station (R.Y.L.); Zhucheng County Skin Disease Control Station (D.M.W.); Zoucheng County Skin Disease Control Station (D.W.); Linshu County Skin Disease Control Station (J.X.L.); Feixian County Skin Disease Control Station (W.K.C.); Sishui County Skin Disease Control Station (H.C.C.); Tengzhou County Skin Disease Control Station (Y.P.L); Shouguang Skin Disease Control Station (W.G.Y). Laixi County Skin Disease Control Station (S.Y.W.); Pingdu County Skin Disease Control Station (K.J.W).

New Approach To Wound Healing May Be Easy On Skin, But Hard On Bacteria

In a presentation to the American Chemical Society meeting, Ankit Agarwal, a postdoctoral researcher at the University of Wisconsin-Madison, described an experimental approach to wound healing that could take advantage of silver's anti-bacterial properties, while sidestepping the damage silver can cause to cells needed for healing.



Silver is widely used to prevent bacterial contamination in wound dressings, says Agarwal, "but these dressings deliver a very large load of silver, and that can kill a lot of cells in the wound."



Wound healing is a particular problem in diabetes, where poor blood supply that inhibits healing can require amputations, and also in burn wards. Agarwal says some burn surgeons avoid silver dressings despite their constant concern with infection.



Using a new approach, Agarwal has crafted an ultra-thin material carrying a precise dose of silver. One square inch contains just 0.4 percent of the silver that is found in the silver-treated antibacterial bandages now used in medicine.



In tests in lab dishes, the low concentration of silver killed 99.9999 percent of the bacteria but did not damage cells called fibroblasts that are needed to repair a wound.



Agarwal builds the experimental material from polyelectrolyte multilayers - a sandwich of ultra-thin polymers that adhere through electrical attraction. To make the sandwich, Agarwal alternately dips a glass plate in two solutions of oppositely charged polymers, and finally adds a precise dose of silver.



"This architecture is very easily tuned to different applications," Agarwal says, because it allows exact control of such factors as thickness, porosity and silver content. The final sandwich may range from a few nanometers to several hundred nanometers in thickness. (One nanometer is one-billionth of a meter; a human hair is about 60,000 nanometers in diameter.)



Nicholas Abbott, a professor of chemical and biological engineering who advises Agarwal, says during the past decade, "about a bazillion papers have been published on polyelectrolyte multilayers. It's been a tremendous investment by material scientists, and that investment is now ripe to be exploited."



The project was supported by seed funding from the Wisconsin Institutes of Discovery - a new unit devoted to advancing technology in five targeted areas, including tissue engineering - and benefited from contributions by Christopher Murphy, Jonathan McAnulty and Charles Czuprynski of UW-Madison's School of Veterinary Medicine; Ronald Raines of the Department of Biochemistry; and Michael Schurr, a burn surgeon at the School of Medicine and Public Health.



Although both mammalian cells and bacteria are sensitive to silver, bacteria are much more sensitive, leaving a sweet spot - a concentration of silver that can kill bacteria without harming cells needed for healing. In tests using mouse cells and sample bacteria, Agarwal has tuned the dose to find the sweet spot where the silver bullet destroys 99.9999 percent of the bacteria, but does not harm fibroblasts.



Indeed, the system is so sensitive that increasing the silver dose from 0.4 percent to 1 percent of the level used in a commercial dressing severely damaged the fibroblasts.



To kill bacteria, silver must take the form of charged particles, or ions, and the tiny silver nanoparticles that Agarwal embeds in the sandwich can be designed to release ions for days or weeks as needed. In contrast, Agarwal says, commercial wound dressings contain a large dose of silver ions, which are released faster and with less control.



The required dose of silver can also be reduced because the new material would be designed to stay in close contact with the wound, Abbott says. "In a commercial dressing, the silver is part of the bandage that is placed on the wound surface. We envision this material becoming incorporated into the wound; the cells will grow over it and it will eventually decay and be absorbed into the body, much like an absorbable suture."



Tests on animals will be needed to before the new material can be tested on humans, says Abbott. "A commercial dressing needs to have a large quantity of silver so it can diffuse to the wound bed, and that quantity turns out to be toxic to mammalian cells in lab dishes. We are putting the silver where we need it, so we can use a small loading of silver, which does not exhibit toxicity to mammalian cells because the silver is precisely targeted."

Summer Sun Safety

Fifty years of medical studies show that sun exposure is a primary component in the development of melanoma, the most serious and deadly type of skin cancer, report leading dermatologists in the April 2006 issue of Dermatology Surgery.



"Though genetics may play a role in the development of some melanomas, there's overwhelming evidence that shows sun exposure adversely affects patients both with and without genetic predisposition to melanoma," said Elisabeth K. Shim, M.D., an Associate Clinical Professor of Dermatology at Keck USC Medical School of Medicine in Los Angeles, CA.



It's not clear what pattern of sun exposure causes melanoma or whether it's short, intense intermittent or cumulative. Further more, it's not clear if ultraviolet B (UVB), ultraviolet A (UVA) rays, or both are responsible for causing melanoma. "Regardless, the sun acts as an initiating and promoting agent in causing melanoma, and causes immunosuppression," noted Dr. Shim.



With summer quickly approaching, it's necessary to protect yourself by using sunscreen and sun protective measures to prevent melanoma, and other skin cancers, despite current controversy.







This study is published in the journal Dermatologic Surgery.



About the journal Dermatologic Surgery

Exclusively devoted to dermatologic surgery, Dermatologic Surgery publishes the most clinically comprehensive and up-to-date information in its field. This unique monthly journal provides today's most expansive and in-depth coverage of skin surgery and skin cancer, through peer-reviewed original articles, extensive illustrations, case reports, ongoing features, literature reviews, meeting coverage, and correspondence.



About the American Society for Dermatologic Surgery

Founded in 1970, the American Society for Dermatologic Surgery is the largest specialty organization in the world exclusively representing dermasurgeons, board-certified physicians who are specifically trained to treat the health, function and appearance of the skin and soft tissue with both medically necessary and cosmetic procedures. For more information on medical or cosmetic skin procedures visit asds/.



About Blackwell Publishing

Blackwell Publishing is the world's leading society publisher, partnering with more than 665 academic, medical, and professional societies. Blackwell publishes over 800 journals and, to date, has published close to 6,000 text and reference books, across a wide range of academic, medical, and professional subjects.



Contact: Heather Noonan

Blackwell Publishing Ltd.

Senetek PLC Announces Debut Of Pyratine-6(TM) At The Annual Meeting Of The American Academy Of Dermatology

Senetek PLC (OTC
Bulletin Board: SNKTY), a Life Sciences company engaged in the development
of technologies that target the science of healthy aging, announced
the debut of Pyratine-6(TM) at the 66th Annual Meeting of the American
Academy of Dermatology in San Antonio, Texas.



Pyratine-6(TM), Senetek's exclusive second generation cytokinin, has
been clinically proven to be effective in correcting visible signs of skin
aging and significantly reducing erythema as early as two weeks from onset
of use.



The Annual Meeting of the American Academy of Dermatology runs from
February 1 - 5, 2008. Approximately 7,000 medical personnel are registered
to attend.



Commenting on the debut, Mr. Frank Massino, Senetek's Chairman and
Chief Executive Officer stated, "We are delighted to see this compelling
therapeutic come to the market and are very pleased by the reception
Pyratine-6(TM) has received from dermatologists at this important
conference. Pyratine-6(TM) has been successfully clinically tested and has
shown attributes more beneficial to treatment than any predecessor
compound."



About Senetek PLC



Senetek PLC (OTC Bulletin Board: SNKTY) is a Life Sciences company
engaged in the development of breakthrough technologies that target the
science of healthy aging. The Company's extensive research collaborations
have resulted in a strong pipeline of patented compounds and products with
broad therapeutic applications and a leading presence in dermatology.
Senetek collaborates with established specialty pharmaceutical companies in
the final development and marketing of its proprietary products, most
recently resulting in the development of the best-selling anti-aging
product sold in the North American physician market.



For more information, visit the company's website at
senetekplc.



This news release contains statements that may be considered
'forward-looking statements' within the meaning of the Private Securities
Litigation Reform Act. Forward-looking statements by their nature involve
substantial uncertainty, and actual results may differ materially from
those that might be suggested by such statements. Important factors
identified by the Company that it believes could result in such material
differences are described in the Company's Annual Report on Form 10-K for
the year 2006. However, the Company necessarily can give no assurance that
it has identified or will identify all of the factors that may result in
any particular forward-looking statement materially differing from actual
results, and the Company assumes no obligation to correct or update any
forward-looking statements which may prove to be inaccurate, whether as a
result of new information, future events or otherwise.


Senetek PLC

senetekplc