Genta Incorporated Announces Fourth Quarter and Year End 2007 Financial Results and Corporate ...(The Company has an ongoing Phase 1-2 tri...),Health

Date:3/12/2008

The Company has an ongoing Phase 1-2 trial that combines Genasense with Abraxane(R) (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) (Abraxis BioScience, Inc.) plus Temodar(R) (temozolomide) Capsules (Schering-Plough Corporation) in patients with advanced melanoma. The new study represents the rapid clinical translation of preclinical results that showed marked anticancer synergy with this drug combination. The new study evaluates the safety, efficacy, pharmacokinetics, and pharmacodynamics of the combination in chemotherapy- nave patients who have normal LDH levels. Updated results from this trial have been submitted to the 2008 annual meeting of the American Society of Clinical Oncology (ASCO).

Phase 3/Chronic Lymphocytic Leukemia (CLL)/NDA Status: In 2007, Genta appealed a prior "non-approvable" decision on the Genasense New Drug Application (NDA) for patients with relapsed/refractory CLL, and the appeal is now pending before the Director of FDA's Center for Drug Evaluation and Research (CDER). Extended follow-up during 2007 has indicated that patients who achieved complete remission (i.e., the study's primary endpoint) on the Genasense treatment arm have also enjoyed extended survival. Updated results from this trial have been submitted to the 2008 annual meeting of the American Society of Clinical Oncology (ASCO). The Company has met with FDA to discuss this appeal, and a decision from CDER is expected in the current calendar quarter.

High-Dose Intermittent Dose-Schedules: The Company has shown that high- dose, intermittent Genasense treatment was active and increased drug uptake in preclinical models of human lung cancer, colon cancer and melanoma. Moreover, twice-per-week Genasense dosing amplified the activity of multiple tyrosine kinase inhibitors, including erlotinib, imatinib, sunitinib and sorafenib, used either alone or in combination with a taxane.

Genta has now completed clinical trials to evaluate in
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SOURCE Genta Incorporated Copyright©2008 PR Newswire. All rights reserved

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