Nuvelo Announces Positive Results from Phase 1 Clinical Trial of NU206 in Healthy Volunteers

Source Press Release
Company NuveloKyowa Hakko KirinARCA biopharmaPathoGenesis 
Tags Phase I, Protein Therapeutic
Date December 10, 2008

San Carlos, CA -- December 10, 2008 -- Nuvelo , Inc. (Nasdaq: NUVO) today announced positive results from the Phase 1 trial of recombinant, secreted protein, NU206, the company's lead compound from its Wnt Therapeutics Program. This single-center, double-blind, placebo-controlled, single-ascending dose (SAD) trial tested the safety, tolerance and pharmacokinetics of a single intravenous (IV) administration of NU206, in 32 healthy male volunteers. Participants were enrolled in four cohorts of varying doses, with a maximum dose of 0.20 mg/kg/day. NU206 had a favorable safety profile, no serious adverse events were observed, and pharmacokinetics were predictable.

"Based on preclinical studies, we believe that NU206 promotes cell growth and repair, and, based also on results from this Phase 1 trial, believe it has the potential to offer a novel approach for the treatment of serious medical conditions such as gastrointestinal (GI) injury, inflammatory bowel disease, and bone disease," said Dr. Ted W. Love, chairman and chief executive officer of Nuvelo . "Because Nuvelo  is in the process of merging with  ARCA biopharma  to create a cardiovascular-focused company, we are currently evaluating partnership and out-licensing opportunities for NU206 to continue development of the compound."

About NU206

NU206 (R-spondin1) is a recombinant, secreted protein that acts as a key regulator of the Wnt pathway, the critical pathway that stimulates cell growth and differentiation during homeostasis and pathogenesis  in specific tissues including the GI epithelium and bone. Preclinical studies suggest it can promote growth and repair in animal models of radiation or cancer chemotherapy induced GI injury, inflammatory bowel disease, and bone disease.

About Nuvelo  and  Kyowa Hakko Kirin 's Joint Collaborative Effort

Scientists from Nuvelo  and  Kyowa Hakko Kirin  worked together to identify and characterize NU206 as part of a collaboration focused on the discovery of novel, secreted proteins.  Nuvelo  signed a collaboration agreement with  Kyowa Hakko Kirin  in April 2005 to develop NU206. Under the agreement,  Nuvelo  leads worldwide development, manufacturing and commercialization and all operating expenses and profits related to the development and commercialization of NU206 are shared 60% (Nuvelo)/40% (Kyowa Hakko  Kirin ).

Source: Evaluate™
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