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Corgentech Begins Phase I/II Trial of E2F Decoy for Prevention of AV Graft Failure in Patients With End-Stage Renal Disease

SOUTH SAN FRANCISCO, Calif., May 18, 2004 /PRNewswire-FirstCall via COMTEX/ -- Corgentech Inc., (Nasdaq: CGTK), a biotechnology company, today announced that patient enrollment has begun in the Phase I/II study of E2F Decoy (edifoligide) for the prevention of arterio-venous (AV) graft failure in patients with end-stage renal disease who require hemodialysis. Corgentech and Bristol-Myers Squibb Company (NYSE: BMY) are jointly developing and commercializing E2F Decoy.

Approximately 100,000 patients in the United States with severe kidney disease require new or revised vascular access, or AV grafts, for dialysis treatment each year. The U.S. Food and Drug Administration (FDA) has granted Fast Track designation for this potential second indication for E2F Decoy. The first indication, also in development, is prevention of vein graft failure.

"AV graft failure is one of the most difficult problems experienced by these already seriously ill patients," said Lynda Szczech, M.D., a principal investigator and Assistant Professor of Medicine, Division of Nephrology, Duke University Medical Center. "E2F Decoy is a treatment designed to prevent the root cause of the blockage, proliferation of smooth muscle cells, that so commonly interrupts these often life-saving connections. We are hopeful that this procedure can help to reduce the additional hospitalizations and surgical procedures this problem causes."

Patients with end stage renal disease require dialysis to survive, and the majority in the U.S. receives AV grafts for dialysis treatment. An AV graft supplies the physical connection between the patient and the dialysis machine required to cleanse their blood. Currently, more than half of these connections require replacement or revision at six months and about 95 percent fail within two years. The majority of these failures are due to narrowing and blockage at the venous connection.

"We are pleased to begin studying the potential application of E2F Decoy in yet another indication that addresses such a high unmet medical need," said John McLaughlin, Corgentech's president and CEO. "Investigating the use of E2F Decoy in this indication is important since there are no approved drugs to preserve AV graft function."

Two large Phase III clinical trials have recently been fully enrolled studying E2F Decoy for coronary artery bypass graft (CABG) failure and peripheral (i.e., in the leg) bypass graft failure directed toward a single indication of prevention of vein graft failure. The FDA has granted E2F Decoy Fast Track status for this indication due to the important unmet medical needs the product may address.

Study Details

This Phase I/II clinical trial is a double-blind, randomized, placebo- controlled study that will enroll 60 patients at up to 20 leading research centers in the United States. The companies expect to announce initial data from this trial in the first half of 2005.

At the time of graft placement, the patient's recipient vein will receive a single treatment with either E2F Decoy or placebo. The study's endpoint is a fistulogram (i.e., x-ray examination using contrast agent) at six months to observe the amount of blockage in the AV graft. Secondary endpoints include determining safety, as well as efficacy of E2F Decoy treatment versus placebo on graft failure, revision or access graft blood flow.

About End-Stage Renal Disease and AV Graft Failure

The hemodialysis treatment involves the insertion of two needles into the patient, one to channel the blood into the dialysis machine and the other to return the blood once filtered. Because unmodified blood vessels cannot withstand repeated needle insertion, AV grafts are surgically implanted in the patient's arm. The majority of access grafts are constructed of artificial conduit material. AV graft failures are most often due to narrowing and blockage at the point of the graft-vein connection caused by smooth muscle proliferation. This thickening of the interior vessel lining, known as neointimal hyperplasia, is similar to that seen in peripheral and coronary artery vein grafts.

Preclinical studies have suggested that pre-treatment of the vein with edifoligide at the grafting site may prevent the build up of smooth muscle cells that leads to failure of these grafts.

About E2F Decoy

E2F Decoy is an oligonucleotide that binds to and inactivates the pivotal cell-cycle transcription factor E2F. E2F is responsible for activating a dozen or more genes that must be turned on during vascular cell growth and multiplication. Its blockade prevents the proliferation of these abnormal cells that eventually result in graft failure.

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 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 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 our operations and other risks detailed in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2003 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 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 of Corgentech, +1-650-624-9600, or
[email protected]; or Daryl Messinger of WeissCom Partners,
+1-415-999-2361, or [email protected], for Corgentech

http://www.corgentech.com

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