Healthcare Industry News:  osteoporosis 

Biopharmaceuticals FDA

 News Release - January 28, 2008

Velcura Therapeutics, Inc. Can Begin Clinical Trials Following Successful Investigational New Drug Application to U.S. FDA

ANN ARBOR, Mich., Jan. 28 (HSMN NewsFeed) -- Velcura Therapeutics Inc., an early stage biotechnology company developing therapies for bone disease, recently completed a successful Investigational New Drug application (IND) to the U.S. Food and Drug Administration (FDA). The IND enables Velcura to proceed with the first-in-man clinical trials for its lead compound, VEL-0230.

VEL-0230 is a new chemical entity that has dual-acting properties, in that it both stimulates bone formation and inhibits bone loss. As part of the application, Velcura presented efficacy, safety, and toxicology data to the FDA, as well as plans for its early-stage clinical trials of VEL-0230. The company plans to investigate VEL-0230 as a treatment of diseases involving bone mineral disorders, such as bone loss related to multiple myeloma, bone metastases, rheumatoid arthritis and osteoporosis.

"The successful completion of the FDA's evaluation within the 30-day review period validates our pre-clinical work and allows us to begin studies of VEL-0230 in humans. Its dual-action bone properties make VEL-0203 an ideal therapy for treating multiple bone diseases," said Michael W. Long, Ph.D., President and Chief Executive Officer of Velcura. "We plan to move into multiple clinical studies as rapidly as possible."

VEL-0230 is being studied as an orally available molecule that promotes bone formation, inhibits bone loss and reduces plasma calcium levels. Extensive laboratory investigations, in vivo animal models, and non-clinical toxicology evaluations demonstrate that VEL-0230 is a safe and effective molecule in these systems. The first phase of clinical trials in humans is planned to begin at the end of February 2008.

About Velcura Therapeutics, Inc.

Velcura Therapeutics Inc. is an early stage biotechnology company headquartered in Ann Arbor, Michigan. Velcura's research focus is to understand human bone disease and to discover novel therapeutics that restore bone health. Velcura develops highly differentiated therapies for bone disease; specifically, dual-acting therapies that demonstrate both bone building and anti-bone loss activities in a single molecule. Velcura uses its patented platform technologies to discover and optimize these compounds. Velcura's lead compound, VEL-0230 was identified using these bone assays. More information is at www.velcura.com.


Source: Velcura Therapeutics

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