Nuvelo, Inc. Announces Published Abstracts And Presentations On rNAPc2 At Transcatheter Cardiovascular Therapeutics 2006 Conference

SAN CARLOS, Calif., Oct. 19 /PRNewswire-FirstCall/ -- Nuvelo, Inc. today announced that additional clinical data from the Phase 2 ANTHEM (Anticoagulation with rNAPc2 To Help Eliminate MACE)/TIMI 32 trial evaluating recombinant nematode anticoagulant protein c2 (rNAPc2) in patients with acute coronary syndromes (ACS) will be presented in both oral and electronic presentations at the Transcatheter Cardiovascular Therapeutics (TCT) 2006 Conference taking place at the Washington Convention Center in Washington, D.C., October 22-27, 2006. New data to be presented include further results from the heparin replacement portion of the trial, additional angiographic core lab outcome measures and clinical outcomes in a subgroup of patients undergoing percutaneous coronary intervention (PCI).

The relevant abstracts are as follows:

Abstract #TCT-32

Novel Tissue Factor/Factor VIIa Inhibitor Reduces Ischemia in Patients with NSTE-ACS: Results of the Dose-Ranging and Heparin De-Escalation Phases of the ANTHEM-TIMI 32 Trial

Abstract #TCT-501

Outcomes in Patients with NSTE-ACS Undergoing PCI on a Novel Tissue Factor/Factor VIIa Inhibitor (rNAPc2) with Full, Half-Dose or No Heparin in the ANTHEM-TIMI 32 Trial

Abstract #TCT-506

Angiographic Outcomes in Patients with Non-STE ACS Undergoing PCI Using Adjunctive Recombinant Nematode Anticoagulant Protein c2 Versus Placebo: An ANTHEM-TIMI 32 Angiographic Core Lab Analysis

Abstracts will also be available online during the conference at www.TCT2006.com. All TCT 2006 abstracts, including the full listings of all authors, are published in this month's supplement edition of the American Journal of Cardiology.

ANTHEM/TIMI 32 Study Details and Results

The ANTHEM/TIMI 32 trial consisted of a Phase 2a dose escalation safety trial and a Phase 2 heparin replacement trial. The Phase 2a dose escalation trial investigated the safety of rNAPc2 in combination with other antithrombotics in 203 patients with non-ST-segment elevation acute coronary syndromes (NSTE-ACS). Safety results from this trial were presented at the 2005 American Heart Association Scientific Sessions and demonstrated that rNAPc2 has an acceptable safety profile and is well tolerated in doses up to 10 mcg/kg in patients being treated for NSTE-ACS.

The Phase 2 heparin replacement study 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.

Results from the entire 255 patient trial were presented at the 2006 World Congress of Cardiology in September 2006. In the study, treatment with higher dose rNAPc2 (greater than or equal to 7.5 mcg/kg) reduced incidence and duration of ischemia by more than 50% in patients being treated with antithrombotics and an early invasive approach for NSTE-ACS as measured by continuous electrocardiogram monitoring. In the heparin de-escalation portion of the trial, rNAPc2 (10 mcg/kg) reduced ischemia even in the absence of heparin and enoxaparin. In addition, rNAPc2 did not increase major/minor bleeding (3.7% vs. 2.5%, p=NS) despite prolonging the time to clot formation in a dose related fashion, as determined by the internationalized normalized ratio. Four cases of procedure-related thrombosis occurred among the no heparin treatment arm, and none occurred in the half-dose heparin arm.

About ACS

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.

About rNAPc2

rNAPc2, a novel anticoagulant, is a recombinant protein fashioned after one originally isolated from the saliva of the dog hookworm. 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.

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 development pipeline includes three acute cardiovascular programs: alfimeprase, a direct-acting thrombolytic in Phase 3 clinical trials for the treatment of thrombotic-related disorders; rNAPc2, an anticoagulant that inhibits the factor VIIa and tissue factor protease complex that recently completed Phase 2 clinical development in acute coronary syndromes; and preclinical candidate NU172, a direct thrombin inhibitor for use as a short-acting 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 and 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; 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 Quarterly Report on Form 10-Q for the quarter ended June 30, 2006 and subsequent filings. We disclaim any intent or obligation to update these forward-looking statements.

CONTACT: Nicole Foderaro, Associate Director of Corporate Communications &IR of Nuvelo, Inc., +1-650-517-8472, or nfoderaro@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/