Healthcare Industry News: allergic rhinitis
News Release - March 6, 2006
Corgentech Presents Clinical Data From Phase 1/2 Trial of Avrina(TM), Drug Candidate for EczemaSOUTH SAN FRANCISCO, Calif., March 6 (HSMN NewsFeed) -- Corgentech Inc. (Nasdaq: CGTK ) today presented clinical data from one of two Phase 1/2 clinical trials of Avrina, Corgentech's NF-kappaB Decoy drug candidate for the treatment of atopic dermatitis, a chronic skin disease also known as eczema that affects about 52 million adults and children in the United States, Europe and Japan. Exploratory analysis of efficacy was conducted in this U.S.-based trial to evaluate anti-inflammatory drug effect, and as previously reported in a top-line data announcement last month, the lowest dose evaluated was the most efficacious. The dose of 0.25% almost achieved statistical significance (p=0.059) in the analysis of the combined eczema score (designated primary efficacy endpoint) at day 22, despite the small patient population (n=23). A statistically significant reduction in change from baseline for the total symptom score (p=0.035) and for the excoriation score (p=0.007) was also observed at day 22 in the 0.25% dose group. At two weeks follow-up after drug discontinuation, a pattern of continued efficacy in these parameters and at this lower dose group suggests a potential disease-modifying or skin healing effect. The primary endpoint of this trial was to establish the safety and tolerability profile of Avrina, and Avrina was shown to be safe and well tolerated. These data were presented over the weekend at the American Academy of Dermatology Meeting in San Francisco, CA.
"We are analyzing the data and meeting with clinical investigators expert in atopic dermatitis to quickly define our plans for the potential future development of this product candidate," stated Daniel J. Gennevois, M.D., vice president, medical affairs at Corgentech. "Avrina is one of four product candidates in our advanced product pipeline, which is focused on pain management and inflammation. Corgentech's most advanced product candidate, ALGRX 3268, has completed Phase 3 trials and is expected to be submitted to the FDA for product approval mid-year."
The Phase 1/2 trial was conducted at multiple clinical sites in the United States and completed enrollment of approximately 75 patients with mild to moderate eczema in October 2005. The trial was randomized, double-blind and placebo-controlled, and patients were randomized in parallel to one of three active treatment dose groups evaluating doses of 0.25%, 0.5% and 1.0% or a control group. Patients applied the study drug twice daily for 21 days to targeted areas of the skin and were followed for 28 days after the final treatment. Periodic physician assessments of the targeted areas were made in both trials to measure the degree of symptom severity as well as patient evaluations of itchiness.
Avrina is a highly selective and potent inhibitor of the transcription factor, NF-kappaB, which is implicated in inflammatory diseases such as eczema, asthma and inflammatory bowel disease (IBD).
Characterized by itchiness, redness and thickening of the skin, eczema is often associated with elevated levels of immunoglobulin E (IgE) and a personal or family history of allergies, allergic rhinitis and asthma. While topical corticosteroids are currently used to treat eczema, their chronic use is limited due to the potential for significant side effects. Topical calcineurin inhibitors have also shown potential in the treatment of this disease; however these potent immunosuppressive agents have yet to produce long-term safety data. In preclinical studies, Avrina was efficiently delivered to intact skin using several easy-to-manufacture, inexpensive formulations and was effective in reducing the swelling and inflammation associated with eczema with minimal side effects.
Corgentech is a late-stage biopharmaceutical company focused on the development and commercialization of novel therapeutic treatments for pain and inflammation. The company has four drug candidates in clinical development for multiple potential indications, the most advanced of which, ALGRX 3268, has completed Phase 3 clinical trials. Corgentech is based in South San Francisco, CA. For more information on the company, please visit www.corgentech.com.
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