The first cohort of six 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 (gallium nitrate injection), a drug that is marketed by Genta and approved in the US 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.
Dr Raymond Warrell, Jr., chairman and CEO said: “The active ingredient in G4544 has shown a consistently high level of clinical activity across a range of skeletal diseases. 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 to rapid approval in hypercalcemia. We also foresee the potential for subsequent approvals in other diseases, such as non-Hodgkin’s lymphoma, bone metastases, Paget’s disease, and osteoporosis. Genta plans to manage the G4544 development program in oncology, and we intend to seek a partner for clinical programs in metabolic bone disease.”