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Corgentech Treats First Patient in Phase 1/2 Trial of New Drug Candidate for Eczema

SOUTH SAN FRANCISCO, Calif., May 24, 2005 /PRNewswire-FirstCall via COMTEX/ -- Corgentech Inc. (Nasdaq: CGTK) today announced that the company has begun treating patients in a multi-center Phase 1/2 clinical trial of its NF-kappaB Decoy (NF-kB Decoy) drug candidate for the treatment of atopic dermatitis, a chronic skin disease also known as eczema that affects about 15 million adults in the United States. This is the first of two Phase 1/2 trials to be initiated. The second trial will be conducted in Australia and Switzerland in approximately 120 patients and is expected to initiate enrollment by mid-2005.

The multi-center, randomized, double-blind, dose-ranging trial will evaluate the safety and feasibility of repeated application of three concentrations of NF-kB Decoy to the skin of adult patients with mild-to- moderate eczema.

NF-kB Decoy is a highly selective and potent inhibitor of the transcription factor, NF-kB, which is implicated in inflammatory diseases such as eczema, asthma and inflammatory bowel disease (IBD).

"We are enthusiastic about the prospects for our NF-kB Decoy based on the pre-clinical data in eczema models that we have observed to date and believe that the drug could someday provide patients with a more convenient dosing regimen and fewer side effects when compared with treatments that are currently on the market," said John P. McLaughlin, president and chief executive officer of Corgentech. "Given the nature of the disease and treatment, eczema studies can be fast clinical trials, so we expect to be able to announce data from these trials and move toward the next step in this program in early 2006."

"There is a medical need for additional treatment alternatives for atopic eczema," stated Jon Hanifin, M.D., professor, department of dermatology, Oregon Health & Science University. "NF-kB Decoy may reduce the inflammation that is part of atopic eczema. We are pleased to participate in the evaluation of this exciting new compound for the treatment of atopic eczema."

Study Details

The study will involve approximately 75 individuals randomized in parallel to one of three active treatment dose groups or a control group. Patients will apply the study drug twice daily for 21 days to targeted areas of the skin. Patients will be followed for 28 days after the final treatment. The study will assess the safety, tolerability and systemic pharmacokinetic profile of NF-kB Decoy. Periodic physician assessments of the targeted area will be made to measure the degree of symptom severity as well as patient evaluations of itchiness.

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, NF-kB Decoy 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. Clinical trials will demonstrate whether results obtained in preclinical studies will be indicative of future results.

About Corgentech

Corgentech is a biopharmaceutical company focused on the development and commercialization of DNA-based novel therapeutics for significant unmet medical needs. We are creating a pipeline of novel therapeutics focused initially on the treatment of inflammatory diseases, infectious diseases and cancer. For more information on the company and its technologies, please visit www.corgentech.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Act of 1995. These include without limitation all statements related to our clinical trials and progress with developing product candidates. Words such as "believes," "anticipates," "plans," "expects," "intend," "will," "slated," "goal" and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon our current expectations. Forward-looking statements involve risks and uncertainties. Our actual results and the timing of events could differ materially from those anticipated in such forward- looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the development of NF-kB Decoy, progress, timing and results of our clinical trials for NF-kB Decoy, intellectual property matters, difficulties or delays in obtaining regulatory approval, manufacturing our product candidates, competition from other pharmaceutical or biotechnology companies, our ability to obtain additional financing to support its operations and other risks detailed in relevant filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K/A for the year ended December 31, 2004 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2005. 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, and Corgentech undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

SOURCE Corgentech

Jennifer Cook Williams, Senior Director, Investor Relations, +1-650-624-9600, or
[email protected]

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