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 (multiplemyeloma)
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 velcura.
Velcura Therapeutics, Inc.
velcura