SAN CARLOS, Calif., June 19, 2007 /PRNewswire-FirstCall/ -- Nuvelo, Inc. today announced the publication of the Phase 2 proof-of-concept data from the Anthem (Anticoagulation with rNAPc2 To Help Eliminate MACE)/TIMI 32 clinical trial (N=255) in the June 26th issue of the Journal of of Cardiology (JACC), demonstrating that higher-dose (greater than or equal to 7.5 mcg/kg) recombinant nematode anticoagulant protein c2 (rNAPc2) reduced the incidence and duration of ischemia as measured by 7-day continuous electrocardiogram (ECG) by more than 50% and did not statistically significantly increase bleeding in patients being treated with standard antithrombotics and an early invasive approach for non-ST-elevation acute coronary syndromes (NSTE-ACS).
"In clinical studies of other antithrombotics, suppression of ischemia monitored by continuous ECG has been associated with a reduction in clinical ischemic events," said Dr. Robert 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 the ANTHEM/TIMI 32 trial, the ability of higher-dose rNAPc2 to reduce ischemia in patients that are already receiving antithrombotic therapy is very exciting, and we look forward to future studies to further understand rNAPc2's potential in this patient population."
ANTHEM/TIMI 32 Study Details and Results
The ANTHEM/TIMI 32 trial consisted of two stages, a dose escalation safety stage and a heparin replacement stage. All patients in the study had 3-lead Holter monitors for assessment of cardiac ischemia, measurement of prothrombin time and F1+2 concentration, and clinical follow-up for up to six months.
The first stage was a double-blind, placebo-controlled, dose escalation study which investigated the safety of rNAPc2 in combination with other antithrombotics in 203 patients with NSTE-ACS. These dat a showed that rNAPc2 has an acceptable safety profile and was well tolerated in doses up to 10 mcg/kg in patients being treated for NSTE-ACS.
The heparin replacement stage was an open-label study evaluating the efficacy and safety of rNAPc2 in combination with half-dose or no unfractionated heparin in 52 patients. The goal of the study was to assess the potential of rNAPc2 by reducing the dose of, and ultimately replacing, unfractionated heparin in patients being treated for NSTE-ACS. Fifty-two patients were enrolled into two cohorts of 26 each. One cohort received 10 mcg/kg rNAPc2 and a half-dose regimen of heparin, and the second cohort received 10 mcg/kg rNAPc2 and no heparin.
Overall, the study enrolled 255 patients with NSTE-ACS and found that rNAPc2 did not statistically increase major plus minor bleeding despite prolonging the time to clot formation in a dose related fashion, as determined by the internationalized normalized ratio (INR). Hemorrhage rates were 2.5%, 2.9%, and 4.5% for placebo, low-dose (1.5-5 mcg/kg), and higher-dose (7.5 and10 mcg/kg) rNAPc2, respectively (overall p=0.77). Five cases of procedure- related thrombosis occurred among the no heparin treatment arm, and none occurred in the half-dose heparin arm. The data also demonstrate that at higher doses, rNAPc2 was associated with a greater than 50% reduction in the incidence and duration of ischemia as measured by continuous ECG monitoring. These same doses suppressed prothrombin fragment F1+2 levels compared to placebo (p<0.01).
ACS accounts for more than one million hospitalizations annually in the United States. It occurs when an atherosclerotic plaque ruptures in a coronary artery, triggering the coagulation cascade, which results in the formation of a blood clot. The clot blocks the flow of blood to the heart muscle depriving it of oxygen (ischemia), which can result in unstable angina or heart attack.
A novel anticoagulan t, rNAPc2 is a recombinant protein that has been shown to have a potential anticoagulant effect resulting from its ability to prevent new thrombin generation by blocking the factor VIIa/tissue factor protease complex, which is the initial step of coagulation or blood clot formation.
In addition, rNAPc2 is being studied as a potential cancer therapy. In animal models, the tissue factor/factor VIIa protease complex has been shown to play a role in activating the cellular signaling events leading to metastasis and angiogenesis in a variety of cancers.
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 for the treatment of thrombotic-related disorders; rNAPc2, an anticoagulant that inhibits the factor VIIa and tissue factor protease complex that completed Phase 2 clinical development in acute coronary syndromes; and preclinical candidate NU172, a direct thrombin inhibitor for use as a short- acting anticoagulant during medical or surgical procedures. Nuvelo is also advancing an emerging oncology pipeline, including rNAPc2 which is in Phase 2 testing for potential use as a cancer therapy, as well as NU206 for the potential treatment of chemotherapy/radiation therapy-induced mucositis and inflammatory bowel disease. 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 potential improvement or benefit that current and future 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 and clinical development processes. These and other factors are identified and described in more detail in Nuvelo filings with the SEC, including without limitation Nuvelo's Quarterly Report on 10-Q for the quarter ended March 31, 2007 and subsequent filings. We disclaim any intent or obligation to update these forward-looking statements.
CONTACT: Nicole Foderaro, Director, Corporate Communications & IR ofNuvelo, +1-650-517-8472, ; or Carolyn Wang of WeissCommPartners, Inc., +1-415-225-5050, firstname.lastname@example.org email@example.com
Web site: http://www.nuvelo.com/
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