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FDA to Extend Review of Data Quality Submission for Genasense(R) in Melanoma
Date:12/21/2007

BERKELEY HEIGHTS, N.J., Dec. 21 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA) announced today that the Company has received notice from the Food and Drug Administration (FDA) that FDA has extended its review period of Genta's request for correction of certain information that was filed pursuant to the Information Quality Act for an additional 60 days. The requested correction relates to FDA's assessment of progression-free survival (PFS) in the Phase 3 trial of Genasense(R) (oblimersen sodium injection) that was presented to the Oncology Drug Advisory Committee (ODAC) that considered Genta's New Drug Application for Genasense in patients with advanced melanoma.

"Melanoma is a key indication in our current Phase 3 development program", said Dr. Loretta M. Itri, M.D., Genta's President for Pharmaceutical Development and Chief Medical Officer. "A methodological error may have impacted ODAC deliberations, which voted unanimously that an improvement in PFS of some magnitude represents clinical benefit that could support regular approval in advanced melanoma."

About Genta

Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. Two major programs anchor the Company's research platform: DNA/RNA-based Medicines and Small Molecules. Genasense(R) (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genta is currently recruiting patients to the AGENDA Trial, a global Phase 3 trial of Genasense in patients with advanced melanoma. The leading drug in Genta's Small Molecule program is Ganite(R) (gallium nitrate injection), which the Company is exclusivel
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SOURCE Genta Incorporated
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