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Genta Updates Progress of its Phase 3 Trial of Genasense(R) in Patients with Advanced Melanoma
Date:6/24/2008

of 2008, with initial data expected shortly thereafter.

About AGENDA

AGENDA is a global Phase 3, randomized, double-blind trial in patients with advanced melanoma. The study is designed to confirm certain safety and efficacy results from an antecedent randomized trial of Genasense combined with dacarbazine (DTIC) in patients who have not previously received chemotherapy (GM301). 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 in GM301, which were observed in 274 patients, showed 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 3.6 mos. 1.6 mos. 0.58 < 0.0001

survival, median

Overall survival, 12.3 mos. 9.9 mos. 0.64 0.0009

median

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 the EADO

The EADO is an independent non-profit organization dedicated to the promotion, coordination, and improvement of clinical and laboratory research activities in the field of skin cancer. The organization has an European and international membership of dermatologists, oncologists and clinical as well as basic research scientists interested in the field of dermato-oncology. EADO provides leadership by formulating and disseminating quality standards and
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SOURCE Genta Incorporated
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