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Corgentech and Bristol-Myers Squibb Announce Results From Edifoligide (E2F Decoy) Phase 3 Trial for Peripheral Bypass Graft
Corgentech to Host Webcast Conference Call Scheduled for 8:30 a.m. EST
"Edifoligide (E2F Decoy) is also being evaluated in a separate Phase 3 study (PREVENT IV) in coronary artery bypass grafts (CABG), and we anticipate the results from this trial by the end of the first quarter of 2005. Following the availability of these results, we will be working with our partner Bristol-Myers Squibb and the FDA on what could be an appropriate development strategy for edifoligide," stated John McLaughlin, president and chief executive officer of Corgentech.
The FDA had previously granted Fast Track status for the use of edifoligide (E2F Decoy) to prevent the failure of bypass grafts.
PREVENT III Trial Design
The Phase 3 clinical trial was a randomized, double blind, placebo- controlled trial involving 1,400 patients undergoing PBG surgery in the leg at approximately 80 centers. Patients were randomized to undergo a one-time treatment with edifoligide (E2F Decoy) or placebo. The trial's primary endpoint compared differences between the treatment and placebo groups in time from the peripheral bypass graft surgery to the first procedure needed to repair a failed/failing vein graft or limb amputation within the 12 months following surgery. Patients were assessed by ultrasound examination at one, three, six and 12 months after bypass surgery to determine if and when a vein graft failed.
PREVENT IV Trial Design
A separate Phase 3 trial, called PREVENT IV, involved 2,400 patients undergoing CABG at over 100 centers and its primary endpoint is the percent reduction in the incidence of critical graft stenosis between the edifoligide (E2F Decoy) treated and placebo groups. Critical graft stenosis is defined in the trial as blockage of the graft of 75 percent or greater as measured by quantitative coronary angiography at 12 months. Today's PREVENT III data are not necessarily predictive of the data to be revealed from PREVENT IV.
Edifoligide (E2F Decoy) Administration
Edifoligide therapy is a treatment applied to the vein by the surgeon in the operating room, just prior to implanting the vein as a bypass. The vein is treated outside of the body by bathing it in the drug in a procedure that is easily incorporated to the standard surgical bypass operation.
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.
About Bristol-Myers Squibb Company
Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.
Conference Call Details
Corgentech will conduct a webcast conference call with the investment community at 8:30 a.m. EST today, December 6, 2004, to discuss the Phase 3 results. The call will be available via live audio broadcast over the Internet on the Corgentech website at www.corgentech.com from the Investor Information page. For those unable to participate via the Internet, a 24-hour replay will be available for seven days after the call by calling (800) 642-1687 (international dial: (706) 645-9291) and giving the following pass code: 2693369.
Corgentech 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 including those relating to results of future clinical trials and the possibility of product approval. 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 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.
Bristol-Myers Squibb Forward-Looking Statements
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding product development. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Edifoligide has not been submitted for regulatory approval. There can be no guarantee that edifoligide will receive regulatory approval, or if approved, will be commercially successful. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on Form 10-K for the year ended December 31, 2003 and in our Quarterly Reports on Form 10-Q. Bristol- Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.
SOURCE Corgentech Inc.
Jennifer Cook Williams, Investor Relations of Corgentech Inc.,
+1-650-624-6900, or [email protected]; or Daryl Messinger of WeissComm
Partners, +1-415-999-2361, or [email protected], for Corgentech; or Robert
Hutchison, Corporate Affairs/Media of Bristol-Myers Squibb Company,
+1-609-252-3901, or [email protected]; or John Elicker, Investor
Relations for Bristol-Myers Squibb Company, +1-212-546-3775, or
[email protected]
http://www.corgentech.com
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