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