Genta Incorporated has received notice that its patent application covering novel pharmaceutical gallium compositions and complexes has been allowed by the US Patent Office. Issued US Patent 7,354,952 extends the intellectual property surrounding the company's franchise of oral gallium-containing products that are intended as potential treatment for diseases associated with accelerated bone loss.
The lead compound in this investigational pipeline, G4544, was developed in collaboration with Emisphere Technologies, Inc. and has completed its initial phase I dose-ranging study. Results of this study would be presented at the Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago, Illinois.
With continued progress in the oral formulation programme, the company has elected to seek a buyer for the intravenous formulation of its on-market product from this franchise, Ganite (gallium nitrate injection). The active ingredient in both Ganite and G4544 is ionic gallium, which is reversibly incorporated into bone where its acts as a potent inhibitor of bone resorption and possibly as a mild anabolic agent to enhance bone formation. Ganite is approved by the US Food and Drug Administration for treatment of patients with cancer-related hypercalcemia that is resistant to hydration. Ganite is exclusively marketed in the US by Genta and is available to patients outside the US on a "named-patient" basis.