Nuvelo Initiates Phase 1 Clinical Trial of NU206 in Healthy Volunteers
News Jul 30, 2008
Nuvelo, Inc. has 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."
In treating inflammatory bowel disease (IBD), physicians can have a hard time telling which newly diagnosed patients have a high risk of severe inflammation or what therapies will be most effective. Now researchers report finding an epigenetic signature in patient cells that appears to predict inflammation risk in a serious type of IBD called Crohn’s disease.