Nuvelo says trial shows rNAPc2 is well-tolerated, has acceptable safety profile for acute coronary syndromes

By E. Janene Geiss

Philadelphia, Nov. 14 - Nuvelo, Inc. said Monday that final results from a phase 2a dose-escalating trial showed that recombinant hematode anticoagulant protein c2 has an acceptable safety profile and is well-tolerated in doses up to 10 mg in patients with acute coronary syndromes.

The multi-center, double-blind, placebo-controlled ascending dose-escalation study was designed to investigate the safety of rNAPc2 in combination with other antithrombotics in 203 patients with acute coronary syndromes, which accounts for more than 1 million hospitalizations annually in the United States, according to a company news release.

The focus was to find a well-tolerated dose in combination with other agents. Patients received aspirin and low-molecular weight heparin or unfractionated heparin.

Results showed that treatment with rNAPc2, in addition to standard antithrombotic therapies in patients with acute coronary syndromes resulted in a dose-related inhibition of thrombin generation without an increase in clinically significant bleeding, officials said.

"We are pleased by the results of the phase 2a study, which demonstrated that rNAPc2 had an excellent bleeding profile across a wide range of doses including the highest dose tested, 10 mg, in patients being treated for [acute coronary syndromes]," Steven R. Deitcher, vice president, medical affairs for Nuvelo, said in the release.

The company is currently conducting a phase 2 heparin replacement study, which should give Nuvelo further indication of the antithrombotic activity of rNAPc2 and its potential ability to replace heparin in acute coronary syndromes, officials said.

"Nuvelo is committed to the clinical development of 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 [acute coronary syndromes] and suggests that it may have therapeutic utility in a variety of other indications," Deitcher added.

The results were presented Monday at the American Heart Association's Scientific Sessions 2005.

San Carlos, Calif.-based Nuvelo is a drug development company focused on acute cardiovascular and cancer therapies.

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