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Corgentech Plans to Expand Clinical Product Pipeline With Phase 1/2 Trial of NF-KB Decoy in Eczema

Company will also highlight HIF Decoy for cancer during product pipeline update today at 9:30 a.m. Eastern

SOUTH SAN FRANCISCO, Calif., Sep 22, 2004 /PRNewswire-FirstCall via COMTEX/ -- Corgentech Inc. (Nasdaq: CGTK), a biotechnology company, today announced that it plans to initiate a Phase 1/2 clinical trial in the first half of 2005 in eczema with NF-Kappa-B Decoy (NF-KB Decoy), a highly selective and potent inhibitor of immune and inflammatory responses. The company also will review results of preclinical studies of its Hypoxia-Inducible Factor Decoy (HIF Decoy), demonstrating compelling tumor inhibition, at a product pipeline update scheduled today from 9:30 a.m. to 12:00 p.m. Eastern (webcast details below).

"Our lead product candidate, edifoligide (E2F Decoy) is tracking well, and top line results are expected for our Phase 3 studies in peripheral bypass graft by the end of this year and coronary artery bypass graft in early 2005. We are, therefore, able to expand our focus to bringing our second and third transcription factor decoys to the clinic, thereby continuing to build long- term value for our shareholders," said John P. McLaughlin, president and chief executive officer of Corgentech. "We are excited about the progress we are making in both our NF-KB Decoy and HIF Decoy programs. Our NF-KB Decoy is also showing promising preclinical results in other diseases beyond eczema such as inflammatory bowel disease. Our HIF Decoy could prove effective against certain cancers where HIF is over-expressed and highly correlated with treatment failure and mortality."

NF-KB Decoy Preclinical Results and Clinical Trial Plan

Corgentech's NF-KB Decoy potently and selectively binds to the transcription factor, NF-KB, and blocks the genes which turn on the inflammatory cascade implicated in inflammatory diseases, such as eczema and inflammatory bowel disease (IBD).

Eczema is a chronic disease that affects the skin and afflicts about 15 million people in the United States alone. In models of eczema, the company has demonstrated that NF-KB Decoy can be efficiently delivered to intact skin using several easy-to-manufacture, inexpensive formulations and is effective in reducing the swelling, blistering and inflammation associated with eczema.

In preclinical models of IBD, NF-KB Decoy has been shown to reduce inflammation of the gut and reverse weight loss associated with this serious unmet medical need that affects more than 700,000 patients in the United States.

Corgentech is planning a Phase 1/2 trial treating approximately 60 individuals with mild to moderate eczema in a multi-center, randomized, double blinded study. It will be a controlled dose escalation study examining safety, pharmacokinetics and efficacy.

"Treatments are needed that have durable long-lasting results and provide patients with a rapid onset of action, convenient dosing and fewer side effects," said Thomas S. Kupper, M.D., T.B. Fitzpatrick Professor of Dermatology at Harvard Medical School, who will speak about NF-KB and its role in inflammation at the Corgentech investor briefing. Dr. Kupper also serves as the Chairman of the Department of Dermatology at Brigham and Women's Hospital and as a Director of the Cutaneous Oncology Program, Dana Farber Cancer Institute as well as Co-Director of the Melanoma and Cutaneous Oncology Program, Dana Farber Harvard Cancer Center.

"Based on the data we have produced to date, we believe that our NF-KB Decoy could address important unmet medical needs with eczema patients, including fast acting results and efficacy similar to steroids without the associated side effects," said Leslie M. McEvoy Ph.D., Corgentech's vice president of research. "We are seeing excellent delivery into skin cells and believe that once-daily application is possible, which would be an advantage over other non-steroidal agents on the market."

HIF Decoy and Cancer

Corgentech's research is focused on blocking HIF, a transcription factor that plays a key role in cancer growth. HIF is over-expressed and highly correlated with mortality in many cancers including breast, lung, pancreatic, ovarian and renal cancers. HIF turns on multiple genes involved in angiogenesis including vascular endothelial growth factor, or VEGF (a validated target for anti-tumor therapy), and it is involved with regulating genes related to cancer cell growth and survival, resistance to radiation and chemotherapy as well as invasion and metastasis.

In preliminary preclinical studies of pancreatic, colon and lung tumor xenograft models in vivo, the company's HIF Decoy showed down-regulation of VEGF and tumor growth inhibition as monotherapy and an additive effect in combination with Avastin(R) and 5-Fluorouracil.

"Finding drugs that inhibit HIF, especially in the specific cancers where it is most often over-expressed, would be a valuable addition to the targeted cancer therapies currently being developed and used," said Gregg L. Semenza, M.D., Ph.D., Professor, Departments of Pediatrics, Medicine, Oncology, and Radiation Oncology, and a member of the Institute of Genetic Medicine, The Johns Hopkins University School of Medicine. Dr. Semenza will describe the potential of targeting HIF as a cancer treatment at today's investor briefing.

About Transcription Factors

Transcription factors (TF) are proteins that regulate genes thereby controlling the biological processes of human cells. Since abnormal gene expression is a fundamental cause of many diseases, targeting transcription factors offers an attractive therapeutic approach to treat many unmet medical needs.

Webcast Details

To access the live webcast or the subsequent archived recording, log on to www.corgentech.com and follow the links from the company's home page. Please connect to Corgentech's website several minutes prior to the start of the webcast to ensure adequate time for any software download that may be necessary.

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. We are 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, including 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 TF Decoys, progress, timing and results of our clinical trials, intellectual property matters, difficulties or delays in obtaining regulatory approval, manufacturing our lead product candidate, 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 June 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.

Richard Powers or Jennifer Cook Williams of Corgentech,
+1-650-624-9600 or [email protected]; or Daryl Messinger of WeissComm
Partners, +1-415-999-2361 or [email protected], for Corgentech

http://www.corgentech.com

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