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DSMB Supports Continuation of Phase 3 AGENDA Trial of Genasense(R) in Advanced Melanoma

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


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:

Endpoint Genasense/DTIC DTIC Ratio P

Overall response 20.8% 7.2% 0.002

Durable response 10.7% 2.4% 0.007


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:

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

SOURCE Genta Incorporated
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