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Nuvelo BEGINS Phase 2 'Proof of Concept' Trial Evaluating rNAPc2 in Patients Being Treated for Acute Coronary Syndromes (ACS)

Posted on: Monday, 22 August 2005, 06:00 CDT

SUNNYVALE, Calif., Aug. 22 /PRNewswire-FirstCall/ -- Nuvelo Inc. today announced enrollment of the first patient in a Phase 2 "proof of concept" clinical trial evaluating rNAPc2 (recombinant nematode anticoagulant protein c2) as a potential replacement for heparin in patients being treated for acute coronary syndromes (ACS). ACS occurs when an atherosclerotic plaque ruptures in a coronary artery, which triggers the coagulation cascade resulting in the formation of a blood clot. The clot blocks the flow of blood to the heart muscle, depriving it of oxygen and resulting in unstable angina or heart attack.

"ACS accounts for more than 1 million hospitalizations annually in the United States. Improved antithrombotic therapies are needed for the treatment of ACS as a significant number of these patients continue to experience poor outcomes such as angina, heart attack and death with the current standard of care," said Robert P. Giugliano, M.D., S.M., 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. "Upon admission to the hospital, these patients are traditionally treated with multiple drugs and the cornerstone of these combination regimens is typically heparin. This heparin replacement pilot study should give us a good indication of rNAPc2's anticoagulation activity and its potential ability to replace heparin in this patient population."

This Phase 2 trial, also known as ANTHEM (Anticoagulation with rNAPc2 To Help Eliminate MACE)/TIMI 32, is a single-arm, open-label study that is evaluating the efficacy and safety of rNAPc2 by reducing the dose of, and ultimately replacing, unfractionated heparin in patients being treated for ACS. The study will include from 50 to 100 patients and is being conducted in approximately 25 centers across the United States and Canada with the TIMI Study Group, led by Eugene Braunwald, M.D., distinguished Heresy professor of medicine at Harvard Medical School and chairman of the TIMI Study Group at Brigham and Women's Hospital. Patients who can be randomized within 48 hours of symptoms will be enrolled in cohorts of 25 patients each. The initial group of patients will receive a half-dose regimen of unfractionated heparin, and 10 micrograms/kg of rNAPc2. The next group will receive no heparin and the same dose of rNAPc2. An additional two cohorts may be added at the discretion of the Operations Committee and the Data Safety Monitoring Board.

"Nuvelo is committed to developing rNAPc2 because we believe its novel mechanism of action, based on its ability to inhibit the initiation of the coagulation cascade and prevent the formation of blood clots, offers the potential to help patients with ACS and suggests that it may have therapeutic utility in a variety of other indications," said Steven R. Deitcher, M.D., vice president, medical affairs for Nuvelo. "This Phase 2 clinical trial builds on the results from our previous dose-escalating Phase 2a study, conducted by the TIMI Group, which showed that rNAPc2 has an acceptable safety profile and is well tolerated in doses up to 10 micrograms/kg in patients being treated for ACS."

In May 2005, Nuvelo announced the completion of patient enrollment in a Phase 2a clinical trial of rNAPc2. This multi-center, double-blind, placebo- controlled, ascending dose-escalation study, known as ANTHEM/TIMI 32, investigated the safety of rNAPc2 in combination with other antithrombotics in 200 patients with ACS. Results showed that rNAPc2 has an acceptable safety profile and is well tolerated in doses up to 10 micrograms/kg in 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 safe and active dose evaluated, compared with placebo in a 4:1 randomization. All patients received aspirin and low molecular weight heparin or unfractionated heparin.

The clinical data set for the Phase 2a, TIMI 32 trial will be presented at the American Heart Association Scientific Sessions 2005 on November 14, 2005 in Dallas, Texas. The poster presentation 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 Dr. Giugliano.

About rNAPc2

A novel anticoagulant, rNAPc2 is a naturally occurring protein that was originally isolated from a 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 shows the potential to block the first step in the cascade, inhibiting coagulation before it starts.

About Nuvelo

Nuvelo, Inc. is engaged in the discovery, development and commercialization of life improving therapeutics for the treatment of human disease. Nuvelo's clinical pipeline includes three product candidates, alfimeprase, a direct acting thrombolytic for the treatment of acute peripheral arterial occlusion (PAO) and catheter occlusion; rNAPc2, an anticoagulant that inhibits the interaction of factor VIIa and tissue factor; and ARC183, a direct thrombin inhibitor that is being developed for use in acute anticoagulant applications. 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 http://www.nuvelo.com/ or by phoning 408-215-4000.

This press release contains "forward-looking statements" regarding the initiation of patient enrollment for 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., +1-408-215-4572 or nestrin@nuvelo.com; or CarolynBumgardner Wang of WeissComm Partners, Inc., +1-415-946-1065 orcarolyn@weisscommpartners.com, for Nuvelo Inc.

Web site: http://www.nuvelo.com/

Source: PRNewswire-FirstCall

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