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Corgentech Files Investigational New Drug Application to Begin Phase 1/2 Trial of New Drug Candidate for Eczema

SOUTH SAN FRANCISCO, Calif., Jan 12, 2005 /PRNewswire-FirstCall via COMTEX/ -- Corgentech Inc. (Nasdaq: CGTK) today announced that the company filed an investigational new drug application (IND) with the U.S. Food and Drug Administration (FDA) to begin a Phase1/2 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 afflicts about 15 million people in the United States alone. This is the first of two Phase 1/2 trials to be initiated. The second trial will be conducted in Europe and is expected to be initiated in the first half of 2005 in a similar patient population.

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 in 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 and inflammatory bowel disease (IBD).

"New and improved treatments for eczema are needed that have durable long-lasting results and provide patients with convenient dosing and fewer side effects," stated Todd J. Lorenz, M.D., chief medical officer of Corgentech. "NF-kB Decoy specifically blocks NF-kB and inhibits genes critical in the progression of eczema and may offer a treatment alternative to currently available drugs."

"We believe that based on our preclinical experiments, NF-kB Decoy can be delivered efficiently into skin cells and could potentially show fast acting results and efficacy approaching that of currently available therapies but without the associated side effects," said John P. McLaughlin, president and chief executive officer of Corgentech.

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 and asthma. While topical corticosteroids are currently used to treat eczema, 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 animal 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.

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 two weeks after the final treatment. Periodic physician assessments of the targeted area will be made to measure the degree of symptom severity as well as patient evaluations of itchiness. The study will also assess the systemic pharmacokinetic profile of NF-kB Decoy.

About Corgentech

Corgentech is a biopharmaceutical company engaged in the discovery, development and commercialization of a new class of therapeutics called transcription factor decoys, or TF Decoys. The company is creating a pipeline of novel therapeutics based on our proprietary TF Decoy technology, focused initially on the treatment of cardiovascular disease, inflammatory disease, and cancer. For more information on the company and its technology, 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 for the year ended December 31, 2003, our Quarterly Report on Form 10-Q for the quarter ended September 30, 2004. 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 Inc.

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

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