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news.Velcura Therapeutics has completed a successful investigational new drug application to the FDA, which enables Velcura to proceed with the first-in-man clinical trials for its lead compound, VEL-0230.
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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, 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.
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.
Michael Long, president and CEO of Velcura, said: “Its dual-action bone properties make VEL-0203 an ideal therapy for treating multiple bone diseases. We plan to move into multiple clinical studies as rapidly as possible.”