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Corgentech Initiates Enrollment in Additional Phase 1/2 Trial of New Drug Candidate for Eczema
SOUTH SAN FRANCISCO, Calif., July 21, 2005 /PRNewswire-FirstCall via COMTEX/ -- Corgentech Inc. (Nasdaq: CGTK) today announced that the company has begun treating patients in its ex-U.S., 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 people in the United States. The 120-patient trial, which has initiated enrollment in Switzerland and Australia, is the second of two parallel Phase 1/2 trials to be initiated. The first trial began treating patients last month and is enrolling patients at several sites around the United States.
The multi-center, randomized, double-blind trial will evaluate the safety and tolerability of once-a-day versus twice-a-day applications of NF-kB Decoy to the skin o 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 pleased to be conducting this overseas study at the same time as our U.S. trial, as this will allow us to more quickly move NF-kB Decoy through our product development process by enabling us to collect data from nearly 200 patients across the two trials," said Daniel J. Gennevois, M.D., vice president of medical affairs at Corgentech. "Eczema studies can be fast clinical trials given the nature and treatment of the disease, so we expect to be able to announce data from the two eczema trials in the first quarter of 2006."
"NF-kB Decoy represents an exciting new approach for reducing inflammation related to atopic eczema, and we are pleased to have the opportunity to participate as a clinical trial site for this excellent product candidate," stated Dr. Gabriela Senti, attending dermatologist, University Hospital, Zurich. "Eczema is a common ailment in all parts of the world, and we are still in need of a treatment which is effective against the disease and also has a good safety profile."
Study Details
The study will involve approximately 120 individuals randomized in parallel to one of three groups divided between patients receiving NF-kB Decoy once a day, patients receiving NF-kB Decoy twice a day and patients receiving placebo. Study participants will apply the study drug for 28 days to targeted areas of the skin and will then be followed for 14 days after the final treatment. The trial 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 confirmation of the safety with extended use of these potent immunosuppressive agents is still needed. 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, Inc.
Jennifer Cook Williams, Senior Director, Investor Relations of Corgentech, +1-650-624-9600, or [email protected]
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