Genasense in Chronic Lymphocytic Leukemia (CLL): With guidance from the Food and Drug Administration's (FDA) Center for Drug Evaluation and Research, the Company is collecting survival and progression data from its completed Phase 3 trial of Genasense plus chemotherapy in patients with relapsed/refractory CLL. Genta has also submitted a proposed confirmatory Phase 3 protocol of Genasense in CLL to the FDA for Special Protocol Assessment (SPA) and to the European Medicines Agency (EMEA) for Scientific Advice.
G4544: A New Oral Drug for Skeletal Diseases
G4544 is the Company's proprietary small molecule that is intended to treat diseases associated with accelerated bone loss. G4544 contains the active ingredient in Ganite(R). Genta has completed a Phase 1 single-dose study of G4544, whose results will be presented at the 2008 ASCO meeting. The Company had a teleconference with FDA's Endocrinology and Metabolism Division that clarified regulatory steps needed to begin more extensive clinical testing. At present, Genta intends to seek approval of G4544 by a 505(b)(2) regulatory pathway, which may shorten development time by allowing use of bioequivalence studies, rather than trials to demonstrate efficacy and safety.
Tesetaxel: A Leading Oral Taxane with Anticancer Activity
Tesetaxel is the latest addition to the Genta oncology portfolio. This
agent was developed to avoid serious effects associated with other taxanes
(such as paclitaxel [Taxol(R); Bristol Myers Squibb] and docetaxel
[Taxotere(R); sanofi aventis]), including severe infusion reactions,
peripheral nerve damage, and drug resistance. More than 250 patients have
received tesetaxel, and th
|SOURCE Genta Incorporated|
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