Velcura Therapeutics, Inc. Reports Positive Pre-IND Meeting With FDA and Plans Early Clinical Trials for New Drug to Treat Multiple Myeloma Bo...( ANN ARBOR Mich. Sept. 24 /- Velcu...),Health

ANN ARBOR, Mich. Sept. 24 /PRNewswire/ -- Velcura Therapeutics, Inc., a biotechnology company developing therapies for bone disease, met with the U.S. Food and Drug Administration (FDA) Sept. 20 to clarify details for the early clinical development of VEL-0230, a drug developed to treat bone disease. The focus of the Pre-Investigational New Drug Application (IND) meeting was to obtain feedback from the FDA's Division of Oncology Drug Products about Velcura's completed preclinical studies, as well as Velcura's near-term clinical development plans for VEL-0230. VEL-0230 is a new chemical entity that has dual-acting properties that both stimulates bone formation and inhibits loss. The company, a 2007 Michigan 50 Companies to Watch award winner, plans to initiate clinical trials in 2008 for the use of this drug as a treatment for Multiple Myeloma, a blood cancer associated with profound bone loss.

Michael W. Long, PhD, President and Chief Executive Officer of Velcura, said, "We appreciate the thoughtful, comprehensive and responsive feedback we received in our pre-IND meeting with the FDA. This clear regulatory advice and direction will greatly assist our IND application planned for late 2007. Our laboratory investigations, in vivo animal models, and extensive non- clinical toxicology evaluations demonstrate that VEL-0230 is a safe and effective molecule. Its dual-action bone properties make it an ideal therapy for multiple bone diseases," Dr. Long added.

VEL-0230 is being studied preclinically for the treatment of diseases involving bone mineral disorders such as bone loss related to multiple myeloma, osteoporosis, bone metastases, and rheumatoid arthritis. Given VEL- 0230's promotion of bone formation, inhibition of bone loss and reduction of calcium levels, Velcura has chosen Myeloma as its lead indication, as the bone fragility, bone pain, high calcium levels and eventual kidney involvement present serious medical and quality of life issues to aff
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