Velcura Therapeutics, Inc. Reports Positive Pre IND Meeting With FDA And Plans Early Clinical Trials To Treat Multiple Myeloma Bone Disease

Main Category: Blood / Hematology
Also Included In: Cancer / Oncology;  Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 25 Sep 2007 - 0:00 PDT

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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 affected patients.

About Multiple Myeloma

Multiple Myeloma is a blood malignancy characterized by the accumulation of malignant cells in the bone marrow. The clinical manifestations of the disease are overproduction of immunoglobulin, bone destruction, bone pain, anemia, high calcium levels and kidney dysfunction. The incidence of Multiple Myeloma is especially high in African-Americans, in whom it is the most common blood cancer. Unlike the bone loss associated with other bone tumors, the Myeloma bone lesions are unique in that they do not heal or repair, despite the patients' having many years of complete remission. This may be related to the inhibition and/or loss of the bone-forming cells during disease progression and increased numbers/activity of cells causing bone loss. Thus Myeloma is a disorder that would benefit from therapies that both stimulate bone formation and retard its loss. To date, no such therapies exist and Velcura believes that VEL-0230 may help those suffering from Multiple Myeloma.

For more information on this disease, contact the Multiple Myeloma Research Foundation (http://www.multiplemyeloma.org)

About Velcura Therapeutics, Inc.

Velcura Therapeutics Inc. is an early stage biotechnology company headquartered in Ann Arbor, Michigan. Velcura's research focus is to better 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 anabolic bone-building and anti-bone-loss activities in a single molecule. Velcura uses its patented platform technologies to discover and optimize compounds that both simulate and inhibit bone growth. Velcura's lead compound, VEL-0230 was identified using these bone assays. More information is at http://www.velcura.com.

Velcura Therapeutics, Inc.
http://www.velcura.com