Genta Incorporated has announced that two new patents related to the Company's franchise in gallium-containing products have issued in the United States.
Applications similar to these patents are pending worldwide, and several additional applications that address other compositions and uses have been filed in the U.S. and other territories. These patents and filings provide for claims of compositions and uses of gallium compounds that can be taken by mouth over extended periods for treatment of skeletal diseases as well as other indications.
The two new patents, US 7,354,952B2 and US 7,456,215B2, provide for the therapeutic use of gallium complexed with various agents that increase the oral bioavailability of the active ingredient and yield superior pharmacokinetics compared with the active ingredient used alone.
G4544 is a new, clinical-stage, tablet formulation that enables oral absorption of the active ingredient contained in Ganite ® (gallium nitrate injection), a drug that is marketed by Genta and approved in the U.S. for treatment of cancer-related hypercalcemia. Genta is developing G4544 in collaboration with Emisphere Technologies, Inc. (NASDAQ: EMIS). The initial clinical study -- a dose-ranging, single-dose evaluation of G4544 in normal subjects - has been completed. Genta is the IND Sponsor and is directing the clinical development program.
"The active ingredient in G4544 has shown a consistently high level of clinical activity across a range of skeletal diseases," said Dr. Raymond P. Warrell, Jr., Chairman and Chief Executive Officer of Genta. "We believe that the emerging safety issues with long-term bisphosphonate therapy can potentially be avoided with G4544. Our goal is to establish bioequivalence to our IV drug in repeat-dose studies that may lead to rapid approval in hypercalcemia. We also foresee the potential for subsequent approvals in other diseases, such as bone metastases, Paget's disease, and osteoporosis."
G4544 was developed to enable extended administration of the active ingredient in Ganite, which may greatly improve patient convenience and avoid the current need for intravenous pumps or hospitalization. The initial focus of clinical studies with G4544 will be to establish its bioequivalence with the intravenous product, potentially enabling rapid regulatory approval of the oral formulation via a 505(b)(2) application in the U.S. Genta holds or has exclusively licensed the intellectual property related to G4544.