Genta Initiates First Clinical Trial with New Oral Drug (G4544) to Treat Bo...( IND Allowed by FDA for Bioequivalence...),Health

IND Allowed by FDA for Bioequivalence Program Starting in Normal Volunteers

BERKELEY HEIGHTS, N.J., Sept. 17 /PRNewswire-FirstCall/ -- Genta Inc. (Nasdaq: GNTA) announced that the Food and Drug Administration (FDA) has allowed the Investigational New Drug (IND) exemption that was submitted by the Company for its new drug known as G4544. In addition, Genta also announced that the first cohort of 6 normal volunteers has been treated with single doses of G4544 without experiencing significant side effects.

G4544 is a new tablet formulation that enables oral absorption of the active ingredient contained in Ganite(R) (gallium nitrate injection), a drug that is marketed by Genta and approved in the U.S. for treatment of cancer- related hypercalcemia that is resistant to hydration. The initial clinical study is a dose-ranging, single-dose evaluation of G4544 that will examine safety and pharmacokinetics of G4544 in human subjects. 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. "Heretofore, an inconvenient dosing schedule has precluded broader use of the IV drug, which may now be resolved with the new oral formulation. We believe that emerging safety issues, such as osteonecrosis, that have been associated with the major competitive drug class of bisphosphonates, can be avoided with G4544. From a regulatory standpoint, we seek to establish bioequivalence to our IV drug, while conducting the additional preclinical and clinical studies to develop repeat-dose programs that may lead
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