Nuvelo, Inc. Initiates Phase 1 Clinical Trial of NU206 in Healthy Volunteers
SAN CARLOS, Calif., July 29 /PRNewswire-FirstCall/ -- Nuvelo, Inc. 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.
Information about Nuvelo is available at our website at http://www.nuvelo.com or by phoning 650-517-8000.
This press release contains "forward-looking statements," which include statements regarding the timing, progress and anticipated completion of Nuvelo's clinical stage and research programs, and the potential benefits that patients may experience from the use of our clinical stage compounds, 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 and the regulatory approval process; 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; and the impact of competitive products and technological changes. These and other factors are identified and described in more detail in Nuvelo's filings with the SEC, including without limitation Nuvelo's quarterly report on Form 10-Q for the quarter ended June 30, 2008 and subsequent filings. We disclaim any intent or obligation to update these forward-looking statements.
CONTACT: Nicole Foderaro, +1-415-946-1058, nfoderaro@wcpglobal.com, or
Danielle Bertrand, +1-415-946-1056, dbertrand@wcpglobal.com, both of
WeissComm Partners, for Nuvelo, Inc.
Web site: http://www.nuvelo.com/