Genta Inc. and Emisphere Technologies, Inc. have jointly announced the submission of an Investigational New Drug Exemption (IND) to the Endocrinologic and Metabolic Drugs Division of the U.S. Food and Drug Administration (FDA) for a new drug known as G4544.
Developed out of a joint collaboration announced last year, 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 1 clinical trial that will examine initial safety and pharmacokinetics of G4544 in human subjects. Genta will act as Sponsor of the IND and will direct the clinical development program.
"The success of this project speaks to the expertise of Emisphere in developing and deploying our patented technology to address poorly absorbed compounds for broader patient use," said Michael Novinski, Chairman and Chief Executive Officer of Emisphere Technologies. "We are excited by the prospect of helping make treatments easier for a broad array of patients."
"Genta has pursued this project for a number of years, and we are very pleased with the results of our collaboration with Emisphere," said Dr. Raymond P. Warrell, Jr., Chairman and Chief Executive Officer of Genta. "With this success, G4544 significantly extends our intellectual property associated with the gallium products franchise. Our initial focus will be to establish clinical bioequivalence with our parenteral product. However, the active ingredient in G4544 has already demonstrated proof-of-concept activity in patients with multiple indications, including non-Hodgkin's lymphoma, bone metastases, Paget's disease, and osteoporosis. Going forward, Genta plans to manage the clinical development programs in oncology, and we intend to seek a partner for programs in metabolic bone disease."
Gallium-Containing Compounds
Gallium-containing compounds were originally developed by the U.S. National Cancer Institute. In investigational studies, high doses of gallium nitrate demonstrated consistent antitumor activity in patients with non- Hodgkin's lymphoma. However, experimental work by Genta personnel and others established that lower doses of gallium directly inhibited calcium release from bone, principally by decreasing bone resorption and possibly by also stimulating bone formation.