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Corgentech Reports Clinical Data From Phase 1/2 Trials of Avrina(TM), Drug Candidate for Eczema

SOUTH SAN FRANCISCO, Calif., Feb 07, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Corgentech Inc. (Nasdaq: CGTK) today reported clinical data from 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 these trials to evaluate anti-inflammatory drug effect, and in both trials the lowest dose evaluated was the most efficacious. The dose of 0.25%, which was studied only in the U.S. trial, almost achieved statistical significance (p=0.059) in the analysis of the combined eczema score despite the small patient population. The primary endpoint of these trials was to establish the safety and tolerability profile of Avrina. Preliminary review of the available safety data indicate that topical application of Avrina in the dose ranges studied in both trials was safe and that Avrina was well tolerated in the most efficacious dose of 0.25%. It is expected that Avrina clinical data will be presented at the American Academy of Dermatology Meeting in San Francisco, CA in early March 2006.

"The clinical data suggest that we need to explore lower doses of Avrina to fully establish its clinical benefit in the treatment of eczema. We will continue to analyze the data and meet 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. "This data announcement is one of many clinical milestones we expect to announce over the coming months from our pipeline of four product candidates for pain management and inflammation. Other expected milestones include the filing of our New Drug Application (NDA) for our lead product candidate, ALGRX 3268, as well as multiple Phase 2 clinical data announcements from another pain product candidate, ALGRX 4975."

Study Details

Both Phase 1/2 trials enrolled patients with mild-to-moderate eczema and were multi-center studies that were randomized, double-blind and placebo-controlled. 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.

The Phase 1/2 trial in the United States completed enrollment of approximately 75 patients in October 2005. The 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.

The ex-U.S. Phase 1/2 trial, which was conducted at multiple sites in Australia and Switzerland, completed enrollment of approximately 120 individuals in December 2005. The patients were randomized in parallel to one of three groups divided between patients receiving a 1.0% dose of Avrina once a day, twice a day and patients receiving placebo. Study participants applied the study drug for 28 days to targeted areas of the skin and were then followed for 14 days after the final treatment.

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).

About Eczema

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.

About Corgentech

Corgentech is a late-stage biopharmaceutical company focused on the development and commercialization of novel therapeutic treatments for pain management and inflammation. Corgentech is based in South San Francisco, CA. For more information on the company, please visit www.corgentech.com.

Forward Looking Statements

This press release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue," and similar expressions are intended to identify such forward-looking statements. Forward-looking statements in this press release include, without limitation, projected timing of FDA filings and clinical data announcements and other matters that involve known and unknown risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from results expressed or implied by this press release. Such risk factors include, among others: whether Corgentech can successfully develop new products and the degree to which these gain market acceptance. Actual results may differ materially from those contained in the forward-looking statements in this press release. Additional information concerning these and other risk factors is contained in Corgentech's Form S-4 as well as Corgentech's Form 10-K/A for the year ended December 31, 2004 and most recently filed Form 10-Q.

Corgentech undertakes no obligation and does not intend to update these forward-looking statements to reflect events or circumstances occurring after this press release. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement.

SOURCE Corgentech Inc.

Jennifer Cook Williams, Vice President, Investor Relations of Corgentech,
+1-650-624-9600, or [email protected]

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