Genta Incorporated Announces Fourth Quarter and Year End 2007 Financial Results and Corporate ...(p Genasense: Clinical and Regulatory A...),Health

Genasense: Clinical and Regulatory Activity

Phase 3/Melanoma: In the third quarter of 2007, Genta initiated a confirmatory, Phase 3, randomized, controlled trial in patients with advanced melanoma, known as AGENDA. The study is designed to confirm certain safety and efficacy results from our prior randomized trial of Genasense combined with dacarbazine (DTIC) in patients who have not previously received chemotherapy. AGENDA employs a biomarker to define those patients who derived maximum clinical benefit during the preceding study. These patients are characterized by low-normal levels of LDH (lactate dehydrogenase), a tumor- derived enzyme that is readily detected in blood. Analysis of those efficacy outcomes, which were observed in 274 patients, showed the following results:

Endpoint Genasense/DTIC DTIC Hazard 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 this study can be accessed at: http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1. In addition to the LDH restriction, the AGENDA study is double-blind and designed with co- primary endpoints of progression-free survival and overall survival. AGENDA will be conducted at 75-100 sites in Europe, North America, Australia and New Zealand. The first interim analysis for safety will be conducted, and an update of patient accrual will be announced, during the current quarter. Accrual is currently expected to complete in the fourth quarter of 2008.

Phase 2/Melanoma:
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