SAN CARLOS, Calif., Nov. 7 /PRNewswire-FirstCall/ -- Nuvelo Inc. today announced that final results from a Phase 2a dose-escalating trial of rNAPc2 in patients with acute coronary syndromes (ACS), known as ANTHEM/TIMI 32, will be presented at the American Heart Association’s Scientific Sessions 2005 in Dallas on Monday, November 14. rNAPc2 (recombinant nematode anticoagulant protein c2) is a novel anti-coagulant currently being studied in a Phase 2 proof of concept clinical trial as a potential replacement for heparin in patients being treated for ACS.
The poster presentation (abstract #2095/C16) entitled “Addition of a Tissue-Factor/Factor VIIa Inhibitor to Standard Treatments in NSTE-ACS Managed with an Early Invasive Strategy: Results of the Phase 2 ANTHEM-TIMI 32 Double-Blind Randomized Clinical Trial,” will be given by Robert P. Giugliano, M.D., associate physician in cardiovascular medicine at Brigham and Women’s Hospital, assistant professor in medicine at Harvard Medical School and investigator with the TIMI Study Group.
Nuvelo will also host a cocktail reception and data presentation on Monday, November 14 at 5:00 p.m. Central Time. A webcast of the presentation portion of the event will begin at 5:30 p.m. Central Time. The event will feature Nuvelo senior management, including Dr. Ted W. Love, CEO and chairman, Dr. Michael Levy, senior vice president of research and development, and Dr. Steven Deitcher, vice president of medical affairs, who will provide an update on Nuvelo’s cardiovascular programs, including a discussion of the rNAPc2 Phase 2a clinical trial results. To access the webcast, please log onto the investor relations section of Nuvelo’s website at www.nuvelo.com.
About ANTHEM/TIMI 32
The Phase 2a multi-center, double-blind, placebo-controlled, ascending dose-escalation study was conducted by the TIMI Group and completed in May 2005. The trial investigated the safety of rNAPc2 in combination with other antithrombotics in approximately 200 patients with ACS. The study consisted of a dose-ranging phase and a dose-confirmation phase. The primary focus of dose ranging was to identify a well tolerated dose in combination with other standard antithrombotic agents. In the dose confirmation phase, 25 patients received 10 micrograms/kg, the highest dose evaluated, compared with placebo in a 4:1 randomization.
About rNAPc2
A novel anticoagulant, rNAPc2 is a naturally occurring protein that was originally isolated from the nematode. The anticoagulant effect of rNAPc2 results from its ability to block the factor VIIa/tissue factor protease complex which is responsible for the initiation of the process leading to blood clot formation. Unlike heparin, thrombin inhibitors and other agents that exert their effects at later stages of the blood coagulation cascade, rNAPc2 blocks the first step in the cascade, inhibiting coagulation before it starts.
About Nuvelo
Nuvelo, Inc. is dedicated to improving the lives of patients through the discovery, development and commercialization of novel drugs for acute cardiovascular and cancer therapy. Nuvelo’s clinical pipeline includes alfimeprase, a direct-acting thrombolytic in Phase 3 trials for the treatment of acute peripheral arterial occlusion (PAO) and catheter occlusion, and rNAPc2, an anticoagulant currently in Phase 2 trials that inhibits the factor VIIa and tissue factor complex. Nuvelo recently identified NU206 as a preclinical development candidate from its proprietary research programs and expects to leverage expertise in secreted proteins and antibody discovery to expand its pipeline and create partnering and licensing opportunities.
Information about Nuvelo is available at our website at www.nuvelo.com or by phoning 650-517-8000.
This press release contains “forward-looking statements” regarding Nuvelo’s Phase 2 clinical trial of rNAPc2 to treat patients with acute coronary syndromes. The timing and progress of Nuvelo’s Phase 2 program, and the potential improvement or benefit that current clinical trial programs may demonstrate which statements are hereby identified as “forward-looking statements” for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. Such statements are based on our management’s current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward looking statements as a result of many factors, including, without limitation, uncertainties relating to drug discovery; clinical development processes; enrollment rates for patients in our clinical trials; changes in relationships with strategic partners and dependence upon strategic partners for the performance of critical activities under collaborative agreements; the impact of competitive products and technological changes; uncertainties relating to patent protection and uncertainties relating to our ability to obtain funding. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo’s recent annual report on Form 10-K for the year ended December 31, 2004 and subsequent filings. We disclaim any intent or obligation to update these forward-looking statements.
Nuvelo, Inc.
CONTACT: Nicole Estrin, Associate Director of Corporate Communications &IR of Nuvelo, Inc., +1-650-517-8472, or nestrin@nuvelo.com; CarolynBumgardner Wang of WeissComm Partners, Inc., +1-415-946-1065, orcarolyn@weisscommpartners.com, for Nuvelo, Inc.
Web site: http://www.nuvelo.com/
