Healthcare Industry News: alfimeprase
News Release - June 1, 2006
Nuvelo Announces Completion of Phase 2 Heparin Replacement Trial Evaluating rNAPc2 in Acute Coronary SyndromesClinical Data From the Phase 2a Dose Escalation Safety Trial and the Phase 2 Heparin Replacement Trial to be Presented at the Upcoming World Congress of Cardiology 2006
SAN CARLOS, Calif., June 1 (HSMN NewsFeed) -- Nuvelo, Inc. (Nasdaq: NUVO ) today announced the completion of the heparin replacement portion of its Phase 2 "proof of concept" clinical trial evaluating rNAPc2 (recombinant nematode anticoagulant protein c2) in patients being treated for acute coronary syndromes (ACS).
"We are pleased to have completed this next phase in testing rNAPc2 and look forward to presenting results from this Phase 2 heparin replacement trial along with efficacy data from the Phase 2a trial at the World Congress of Cardiology meeting in September of this year," said Robert P. Giugliano, M.D., S.M., investigator, TIMI Study Group; associate physician, Brigham and Women's Hospital and assistant professor of medicine, Harvard Medical School. "In November of last year we shared data from the previous Phase 2a safety trial showing that rNAPc2 has an acceptable safety profile and is well tolerated in doses up to 10 micrograms/kg in combination with other antithrombotics in 200 patients with ACS. Given what we know about its mechanism of action, we are very interested in evaluating rNAPc2's effect when the standard dose of heparin is either reduced or eliminated."
Phase 2 Study Design
The Phase 2 trial, also known as ANTHEM (Anticoagulation with rNAPc2 To Help Eliminate MACE)/TIMI 32, was a single-arm, open-label study evaluating the efficacy and safety of rNAPc2 by reducing the dose of, and ultimately replacing, heparin in patients being treated for ACS. Patients were randomized into two cohorts of approximately 25 to receive either a half-dose regimen of heparin and 10 micrograms/kg of rNAPc2 or no heparin and the same dose of rNAPc2. The 52 patient study was conducted in 24 centers across the United States and Canada by the TIMI Study Group, led by Eugene Braunwald, M.D., distinguished Hersey professor of medicine at Harvard Medical School and chairman of the TIMI Study Group at Brigham and Women's Hospital.
"Data from this heparin replacement trial will add to a significant body of evidence evaluating rNAPc2 in approximately 700 patients from multiple Phase 1 and 2 trials. This efficacy data, when combined with positive results from the initial Phase 2a dose-escalating safety trial, provides clinical evidence of the value of rNAPc2," said Steven R. Deitcher, M.D., vice president of medical sciences at Nuvelo. "In addition, we believe that rNAPc2 has promise as an interesting therapy for cancer, and we look forward to sharing our clinical plans at our upcoming R&D day in June."
About Acute Coronary Syndromes (ACS)
ACS accounts for more than one million hospitalizations annually in the United States and 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. 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.
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 shows the potential to block the first step in the cascade, inhibiting the coagulation cascade before it starts.
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 development pipeline includes three acute cardiovascular programs: alfimeprase, a direct-acting thrombolytic in four Phase 3 clinical trials for the treatment of thrombotic-related disorders; rNAPc2, an anticoagulant that inhibits the factor VIIa and tissue factor protease complex which recently completed Phase 2 clinical development in acute coronary syndromes; and a thrombin inhibiting aptamer for anticoagulation during medical procedures. Nuvelo is also advancing an emerging oncology pipeline, which includes NU206 for the potential treatment of chemotherapy/radiation therapy-induced mucositis, as well as rNAPc2 for potential use as a cancer therapy. In addition, Nuvelo expects to leverage its expertise in secreted proteins and cancer antibody discovery to further expand its pipeline and create additional 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 the timing and progress of Nuvelo's clinical programs, the potential improvement or benefit that current and future clinical trial programs may demonstrate, and the numbers of patients who may be eligible for treatment, 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, 2005 and subsequent filings. We disclaim any intent or obligation to update these forward-looking statements.
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