Bone loss is associated with many different diseases, such as osteoporosis, metastasis in cancer, Parkinson’s disease, Paget’s disease and hypercalcemia. Regardless of its derivative, accelerated bone loss can hinder everyday tasks.
Genta Inc. (OTCBB: GNTA) is a biopharmaceutical company with a diversified product portfolio focused on developing innovative products aimed at the treatment of cancer and diseases associated with accelerated bone loss. The company today announced its final results for its phase 1 clinical trial of G4544, a proprietary small molecule intended to treat diseases associated with accelerated bone loss.
G4544 is a new tablet formulation using delivery technology developed by Emisphere Technologies Inc. It enables oral absorption of the active ingredient contained in Ganite (gallium nitrate injection), which is marketed by Genta and is approved in the U.S. for treatment of cancer-related hypercalcemia that is resistant to hydration.
Previous research by the company found that low doses of the active ingredient in Ganite directly inhibited calcium release from bone, thereby decreasing bone resorption and possibly stimulating bone formation.
The recent study showed the drug to be well-tolerated in the 30 volunteers, and that blood levels were achieved in a range that is known to be clinically bioactive. Low doses of the active ingredient in Ganite were administered intravenously and have shown clinical activity in a range of skeletal diseases, including hypercalcemia, bone metastasis (myeloma and breast cancer), Paget’s disease, and osteoporosis.
“G4544 offers both ease of administration and patient convenience that could considerably expand the usefulness of this highly active compound,” Dr. Raymond P. Warrell, Jr., chairman and CEO of Genta stated in the press release. “We concluded our initial conference with FDA’s Endocrinology and Metabolism Division to clarify next steps. Completion of abbreviated toxicology work should enable multi-dose studies to proceed that are needed to secure regulatory approval. The published clinical activity using low doses should be highly informative in guiding further clinical development.”
The data were also featured in a poster session at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago on Saturday, May 31, 2008.
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