Advanced Viral
Research Corp. (OTC Bulletin Board: ADVR), announced that it has
commenced a Phase IIb efficacy study for AVR123 in wound healing.
The Phase IIb trial is being conducted at the Friedrich Alexander
University Hospital in Erlangen Germany, led by Eckhart Kampgen, M.D.,
Associate Professor for Strategies of Cellular Immunotherapy at the
Department of Dermatology. Dr. Kampgen is leading the Immunomonitoring, RNA
and Melanoma Division at the hospital. He has over 80 peer-reviewed
publications and has participated as Principal Investigator or
Sub-Investigator in more than 20 Phase I, II and III clinical studies since
1995.
The primary objective of this study is to evaluate the effect of
AVR123, applied topically, on the rate and quality of healing of wounds.
According to the protocol, patients enrolled in the study will include
individuals with a variety of wounds and dermatologic conditions.
AVR123 is a topical formulation of ARV118 which is currently being
investigated for the systemic treatment of cancer related clinical
cachexia. This compound has well-documented anti-inflammatory and wound
healing activities. Results of a Phase I, open label, dose-escalating study
indicated that topical AVR123 is well-tolerated, showing no dose-limiting
toxicities. Initial observations of accelerated wound healing in a pig
study at the University of Miami suggest that AVR123 may represent an
important advance in the management of wounds.
Stephen Elliston, President and Chief Executive Officer of Advanced
Viral, stated, "This trial has been designed to provide further evidence to
substantiate encouraging preliminary results seen in the initial phase of
the study, which was not completed due to the death of the study's
Principal Investigator. We are highly fortunate to have Dr. Kampgen, a
prestigious leader in the dermatological field, to oversee this trial. His
experience in this area will be invaluable for gaining greater insights
into AVR123's potential efficacy."
"We are highly excited with the prospects for introducing AVR123 into
Europe," added Mr. Elliston. "This is the first time that ADVR has
conducted a trial in Europe, which now represents a market almost as large
as the U.S."
Dr. Kampgen said, "Very few drugs, other than antibiotics, are approved
for wound healing and we are delighted to be working with AVR123. Initial
studies will involve patients with lesions similar to wounds treated in the
University of Miami pig study. Based on positive results from this study,
it is conceivable that AVR123 may play an even more important role in the
treatment of more serious patient populations, such as those with chronic
ulcers."
The global wound care market is estimated to be over $7 billion
annually. It is comprised of a wide variety of prescription and over the
counter products that include antibiotics, antiseptics and dressings. The
US$4.1 billion global advanced wound care segment is the fastest growing
area with double-digit growth of 10% per year.
In tandem with the commencement of this trial, ADVR has received the
third installment of financing from Yorkville Capital partners in the
amount of $249,500.
About Advanced Viral Research Corp.
Advanced Viral Research Corp. is a biopharmaceutical company dedicated
to the discovery and development of small molecule anti-cancer drugs. Its
initial compounds, AVR118 and AVR123, represent a new class of
cytoprotective agent that targets, among other things, some of the most
problematic symptoms associated with clinical cachexia or the so called
wasting syndrome. In addition, AVR118 and AVR123 have also been shown to
possess topical wound healing properties in animal models. Various
degenerative conditions associated with cachexia such as cancer, HIV-AIDS
and chronic inflammation are potential disease targets for AVR118 and
AVR123 therapies. For further information regarding Advanced Viral Research
Corp., please visit the website at adviral.
This news release contains forward-looking statements that involve
risks associated with clinical development, regulatory approvals, including
application to the FDA, product commercialization and other risks described
from time to time in the SEC reports filed by the Company. AVR118 and
AVR123 are not approved by the U.S. Food and Drug Administration or any
comparable agencies of any other countries. There is no assurance that the
Company will be able to secure the financing necessary to continue
operations and/or complete the clinical trials of AVR118 or AVR123, or
satisfy certain other conditions relating to clinical trials or that if the
trials are completed, this will assist the Company in obtaining FDA or
other regulatory approval. The Company undertakes no obligation to update
or revise the information contained in this announcement whether as a
result of new information, future events or circumstances or otherwise.
Advanced Viral Research Corp.
Research Corp. (OTC Bulletin Board: ADVR), announced that it has
commenced a Phase IIb efficacy study for AVR123 in wound healing.
The Phase IIb trial is being conducted at the Friedrich Alexander
University Hospital in Erlangen Germany, led by Eckhart Kampgen, M.D.,
Associate Professor for Strategies of Cellular Immunotherapy at the
Department of Dermatology. Dr. Kampgen is leading the Immunomonitoring, RNA
and Melanoma Division at the hospital. He has over 80 peer-reviewed
publications and has participated as Principal Investigator or
Sub-Investigator in more than 20 Phase I, II and III clinical studies since
1995.
The primary objective of this study is to evaluate the effect of
AVR123, applied topically, on the rate and quality of healing of wounds.
According to the protocol, patients enrolled in the study will include
individuals with a variety of wounds and dermatologic conditions.
AVR123 is a topical formulation of ARV118 which is currently being
investigated for the systemic treatment of cancer related clinical
cachexia. This compound has well-documented anti-inflammatory and wound
healing activities. Results of a Phase I, open label, dose-escalating study
indicated that topical AVR123 is well-tolerated, showing no dose-limiting
toxicities. Initial observations of accelerated wound healing in a pig
study at the University of Miami suggest that AVR123 may represent an
important advance in the management of wounds.
Stephen Elliston, President and Chief Executive Officer of Advanced
Viral, stated, "This trial has been designed to provide further evidence to
substantiate encouraging preliminary results seen in the initial phase of
the study, which was not completed due to the death of the study's
Principal Investigator. We are highly fortunate to have Dr. Kampgen, a
prestigious leader in the dermatological field, to oversee this trial. His
experience in this area will be invaluable for gaining greater insights
into AVR123's potential efficacy."
"We are highly excited with the prospects for introducing AVR123 into
Europe," added Mr. Elliston. "This is the first time that ADVR has
conducted a trial in Europe, which now represents a market almost as large
as the U.S."
Dr. Kampgen said, "Very few drugs, other than antibiotics, are approved
for wound healing and we are delighted to be working with AVR123. Initial
studies will involve patients with lesions similar to wounds treated in the
University of Miami pig study. Based on positive results from this study,
it is conceivable that AVR123 may play an even more important role in the
treatment of more serious patient populations, such as those with chronic
ulcers."
The global wound care market is estimated to be over $7 billion
annually. It is comprised of a wide variety of prescription and over the
counter products that include antibiotics, antiseptics and dressings. The
US$4.1 billion global advanced wound care segment is the fastest growing
area with double-digit growth of 10% per year.
In tandem with the commencement of this trial, ADVR has received the
third installment of financing from Yorkville Capital partners in the
amount of $249,500.
About Advanced Viral Research Corp.
Advanced Viral Research Corp. is a biopharmaceutical company dedicated
to the discovery and development of small molecule anti-cancer drugs. Its
initial compounds, AVR118 and AVR123, represent a new class of
cytoprotective agent that targets, among other things, some of the most
problematic symptoms associated with clinical cachexia or the so called
wasting syndrome. In addition, AVR118 and AVR123 have also been shown to
possess topical wound healing properties in animal models. Various
degenerative conditions associated with cachexia such as cancer, HIV-AIDS
and chronic inflammation are potential disease targets for AVR118 and
AVR123 therapies. For further information regarding Advanced Viral Research
Corp., please visit the website at adviral.
This news release contains forward-looking statements that involve
risks associated with clinical development, regulatory approvals, including
application to the FDA, product commercialization and other risks described
from time to time in the SEC reports filed by the Company. AVR118 and
AVR123 are not approved by the U.S. Food and Drug Administration or any
comparable agencies of any other countries. There is no assurance that the
Company will be able to secure the financing necessary to continue
operations and/or complete the clinical trials of AVR118 or AVR123, or
satisfy certain other conditions relating to clinical trials or that if the
trials are completed, this will assist the Company in obtaining FDA or
other regulatory approval. The Company undertakes no obligation to update
or revise the information contained in this announcement whether as a
result of new information, future events or circumstances or otherwise.
Advanced Viral Research Corp.
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