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DSMB Supports Continuation of Phase 3 AGENDA Trial of Genasense(R) in Advanced Melanoma
Date:3/31/2008

ed with enrollment from new sites that will open in the near future, should allow us to maintain our timelines for completion of accrual."

About AGENDA

AGENDA employs a biomarker to define those patients who derived maximum clinical benefit during a large randomized study of DTIC with or without Genasense, known as study GM301. These patients are characterized by low- normal levels of LDH (lactate dehydrogenase), a tumor-derived enzyme that is readily detected in blood. Analysis of the previous efficacy outcomes observed in 274 patients from GM301, which AGENDA is designed to confirm, yielded the following results:
Hazard

Endpoint Genasense/DTIC DTIC Ratio P

Overall response 20.8% 7.2% 0.002

Durable response 10.7% 2.4% 0.007

Progression-free

survival, median 3.6 mos. 1.6 mos. 0.58 <0.0001

Overall survival,

median 12.3 mos. 9.9 mos. 0.64 0.0009

A scientific article that describes efficacy and safety results from GM301 can be accessed at: http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1.

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 n
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SOURCE Genta Incorporated
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