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Nuvelo today announced that it has enrolled the first subject in a single-center, Phase 1 trial of recombinant, secreted protein, NU206, the company's lead compound from its Wnt Therapeutics Program
SAN CARLOS, CA, USA | July 29, 2008 | Nuvelo, Inc. (Nasdaq: NUVO) today announced that it has enrolled the first subject in a single-center, Phase 1 trial of recombinant, secreted protein, NU206, the company's lead compound from its Wnt Therapeutics Program. This double-blind, placebo-controlled, single-ascending dose (SAD) trial will determine the safety, tolerance and pharmacokinetics of a single intravenous (IV) administration of NU206, in approximately 48 healthy male volunteers. Participants will be enrolled in up to six cohorts of varying doses, with a maximum dose of 0.80 mg/kg.
"The initiation of this healthy volunteer trial, coupled with the Phase 1b multiple-ascending dose study that will start later this year or early next year, allows us to accelerate NU206 development," said Dr. Ted W. Love, chairman and chief executive officer of Nuvelo. "Due to its ability to promote cell growth and repair in preclinical studies, we believe NU206 has the potential to offer a novel approach for the treatment of serious medical conditions including gastrointestinal (GI) injury, inflammatory bowel disease and bone disease. The two healthy volunteer trials will provide useful insight for the multiple indications that we plan to investigate with NU206."
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, bone disease and wound healing.
About Nuvelo and Kirin's Joint Collaborative Effort
Scientists from Nuvelo and 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 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% (Kirin).
About Nuvelo
Nuvelo, Inc. is dedicated to improving the lives of patients through the discovery, development and commercialization of novel drugs for acute cardiovascular disease, cancer and other debilitating medical conditions. Nuvelo's development pipeline includes NU172, a direct thrombin inhibitor in Phase 1 development for use as a potential short-acting anticoagulant during medical or surgical procedures; and NU206, a Wnt pathway modulator in Phase 1 development for the potential treatment of chemotherapy/radiation therapy-induced mucositis and inflammatory bowel disease. In addition, Nuvelo is pursuing research programs in leukemia and lymphoma therapeutic antibodies and Wnt signaling pathway therapeutics to further expand its pipeline and create additional partnering and licensing opportunities.
SOURCE Nuvelo, Inc. |
