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Genta Initiates First Clinical Trial with New Oral Drug (G4544) to Treat Bone Disease
Date:9/17/2007

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."

Gallium-Containing Compounds

G4544 is one of a class of gallium-containing compounds that 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.

Many diseases are associated with accelerated bone loss, including osteoporosis, cancer, and Paget's disease. In some diseases, the rate of loss is slow and subtle, while in others the rate is rapid and acutely life- threatening. In osteoporosis, the most prevalent bone-losing condition, the process of bone loss extends over many years before the disease becomes evident. Conversely, in cancer-related hypercalcemia, bone loss is so rapid that it overwhelms the kidney's ability to eliminate calcium from the blood, and this condition can quickly become lethal. In patients with cancer-related hypercalcemia who were resistant to hydration, randomized double-blind trials have been conducted with Ganite compared with calcitonin and with two bisphosphonates (etidronate [Didronel(R); Proctor and Gamble] and pamidronate [Aredia(R); Novartis, Inc.]).

About G4544

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 clinica
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SOURCE Genta Inc.
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