Genta and Emisphere Technologies File IND for Bone Disease Candidate

Genta and Emisphere Technologies jointly announced the submission of an investigational new drug (IND) exemption to the Endocrinologic and Metabolic Drugs Division of the FDA for a new drug known as G4544.

According to Genta and Emisphere, G4544 is a new 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 that is resistant to hydration.

The IND proposes a Phase I clinical trial that will examine initial safety and pharmacokinetics of G4544 in human subjects, the companies said. Genta added that will act as sponsor of the IND and will direct the clinical development program.