Cutanea Announces Promising Phase II Results In Rosacea With Omiganan

Cutanea Life Sciences, an
emerging specialty pharmaceutical company focused on improving human health
and appearance through the development and commercialization of treatments
for diseased and aging skin conditions, announced results from its
completed Phase II clinical trial of Omiganan.



The trial compared Omiganan 2.5% and 1% topical gel to vehicle in
subjects with papulopustular rosacea. Study results demonstrated that the
formulation was safe and well-tolerated at all doses tested. Among the
once-daily treatment arms, a dose-dependent response was observed in both
lesion reductions and Treatment Success, as defined by Investigator Global
Assessment (IGA) scores. After nine weeks of treatment, once-daily (QD)
Omiganan 2.5% gel showed superior lesion count reductions and Treatment
Success, compared to 1% Omiganan QD and vehicle. Omiganan provided greater
improvements compared to vehicle among patients with a more severe
condition at Baseline (more numerous inflammatory lesions). Lesion counts
continued to drop at all evaluations over the duration of the study,
indicating that further improvements may be expected with a duration of
treatment exceeding nine weeks. Twice daily (BID) application of 2.5%
Omiganan did not demonstrate substantial improvement in lesion reduction or
the number of patients reaching Treatment Success compared to once daily
application. Based on the results from this study, Cutanea has selected a
once-daily dose of Omiganan 2.5% for further development for the treatment
of papulopustular rosacea.



Dr. Guy Webster, Founding and Current President of the American Acne &
Rosacea Society and Clinical Professor of Dermatology at Jefferson Medical
College stated, "Topical Omiganan is a novel approach, actually the first
in a new class of dermatologic drugs, for the treatment of rosacea. Initial
results are promising and I look forward to a more precise estimation of
the effectiveness of the drug in the larger Phase III program."



The objective of this exploratory Phase II study was to find the
optimal dose and regimen of Omiganan for further study as a treatment for
rosacea. The trial enrolled 240 patients with papulopustular rosacea and
Investigator Global Assessment (IGA) scores of grade 3 or 4 (moderate to
severe disease). Patients were randomized into one of five treatment groups
in a 2:2:2:1:1 ratio: Omiganan 1% QD, Omiganan 2.5% QD, Omiganan 2.5%
twice-daily (BID), Vehicle QD, or Vehicle BID. During the total nine-week
treatment period, safety and efficacy assessments were performed at weeks
one, three, six, and nine.



The primary efficacy endpoint was mean percent reduction in the number
of inflammatory lesions from Baseline to Week 9. Patients receiving
once-daily Omiganan 2.5% showed a mean 31% reduction in the number of
inflammatory facial lesions compared to a 14% reduction in patients
receiving once-daily vehicle. And, among rosacea patients with 18 or more
lesions at Baseline, the mean reduction for once-daily Omiganan 2.5% was
40%, compared to an 11% lesion increase in the once-daily vehicle group.
















Secondary endpoints included the absolute change from Baseline in the
number of inflammatory lesions at Week nine and at each interim visit, the
percent change in number of inflammatory lesions at interim visits, the
absolute change from Baseline in IGA score and other signs and symptoms of
rosacea at Week nine and each interim visit, and Treatment Success at Week
nine and each interim visit.



Although a statistically significant difference between active and
vehicle was not achieved for the primary endpoint, this study demonstrated
that in both the intent-to-treat and the per protocol populations, Omiganan
2.5% QD was statistically significantly better than vehicle QD at Week nine
in the absolute change of inflammatory lesions (p=0.041 for
intent-to-treat, and p=0.012 for per protocol populations). While in this
exploratory study this endpoint was identified as a secondary end point,
FDA currently requires the absolute change (rather than percent change) in
the number of inflammatory lesions as one of the co-primary endpoints,
along with Treatment Success, for demonstrating efficacy in a Phase III
trial in rosacea.



"Based on these encouraging results, we have selected once-daily
Omiganan 2.5% for further study in rosacea, which is a critical step
towards potential commercialization, either directly or in collaboration
with a partner," commented Robert J. Bitterman, President and CEO of
Cutanea.



About Rosacea



Rosacea is a chronic dermatologic disorder with no current cure and a
poorly understood etiology that afflicts an estimated 14 million Americans.
Symptoms primarily manifest on the facial skin and include facial flushing,
central facial inflammatory lesions, and facial erythema. According to
surveys conducted by the National Rosacea Society (NRS), nearly 70% of
rosacea patients said the disorder had lowered their self-confidence and
self-esteem; 41% reported it had caused them to avoid public contact or
cancel social engagements; and nearly 30% claimed to have missed work due
to rosacea. Of these rosacea patients surveyed by the NRS that sought
medical treatment, over 70 percent reported an improvement in their
emotional and social well-being.



Typical onset of rosacea occurs between 30 and 50 years of age and is
more prevalent in women than men. Clearing up the initial outbreak is only
the beginning, as rosacea is characterized by periods of relapses and
remissions. Relapse episodes can be spurred by sun exposure, stress, hot or
cold weather, alcohol, spicy foods, exercise, and certain skin care
products and medications.



Absent a cure for rosacea, treatment is aimed at alleviating the
disorder's symptoms. Topical or oral medications are generally prescribed
for mild to moderate papulopustular Rosacea, while oral medications are
prescribed for severe disease. Current oral antibiotic therapies may
alleviate symptoms of rosacea, but may present an issue with undesirable
side effects). While there are other topical products currently available
on the market, there is an opportunity to improve the existing irritation
profile for these treatments.



About Omiganan



Cutanea Life Sciences licensed the exclusive worldwide rights for
dermatological uses to a novel, cationic, antimicrobial peptide, whose
active component is omiganan pentahydrochloride from Migenix Inc., a
British Columbia Corporation located in Vancouver, BC, Canada (TSX: MGI;
OTC: MGIFF). Omiganan is in development as a topical treatment for
papulopustular rosacea and may prevent the inflammatory cascade that is
theorized to lead to the signs and symptoms of rosacea. Omiganan topical
gel has been evaluated in early stage clinical trials at concentrations of
0.5% and 3.0%, and early and late stage trials at 1.0%. At each of these
concentrations and in all trials conducted, omiganan was found to be safe,
well tolerated and non-irritating with no evidence of systemic absorption.
While cationic antimicrobial peptides, such as Omiganan, are well known for
their antimicrobial properties, recent research has shown that they also
may play a role in the inflammatory response. Omiganan, in in vitro assays,
demonstrated a rapid bactericidal activity against microorganisms that
colonize the skin and that may play a role in the pathogenesis of
inflammatory lesions.



About Cutanea



Cutanea Life Sciences is an emerging specialty pharmaceutical company
focused on improving human health and appearance through the development
and commercialization of treatments for diseased and aging skin conditions.
The Company strives to maximize value through flawless execution of
strategically designed programs. Its core strategy is to in-license novel,
patented, mid- stage treatment candidates for aggressive development as
potential market- leading dermatologic treatments for commercialization or
out-license. The Company focuses on leveraging each of its products to
address a variety of indications that serve the collective interest of
patients and medical professionals.



Cutanea Life Science's core competencies include a team of
professionals with more than 90 years of combined experience in developing
and commercializing healthcare products. In addition to the core team,
Cutanea is advised by a broad network of technical and commercial experts,
as well as practicing physicians and key medical opinion leaders.



Cutanea Life Sciences is a member of the family of bio/pharmaceutical
companies founded in conjunction with Paramount BioSciences, LLC.



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