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Genasense Plus Chemotherapy Is Associated With Prolonged Survival in Patients With Relapsed/Refractory CLL Who Achieve Complete Remission
Date:12/10/2007

therapy.

Genta has filed a currently pending appeal to the Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER), which seeks reconsideration of FDA's decision in December 2006 not to approve the use of Genasense in patients with relapsed/refractory CLL.

"The addition of Genasense to chemotherapy has resulted in a clinically meaningful survival benefit for patients who achieved CR," commented Dr. O'Brien. "These data strongly confirm the high degree of clinical benefit that accrues to patients who achieve CR. Achievement of CR remains an essential goal of CLL treatment."

"As one of the patients who remains in CR more than 4 years after receiving Genasense on this study, I strongly support the pending appeal of FDA's decision that declined to make this drug available to other patients who suffer from CLL," commented Thomas F. Mahoney, who entered the Phase 3 Genasense trial in 2002.

Genasense in CLL

In the Phase 3 trial, patients with relapsed or refractory CLL were randomly assigned to receive chemotherapy with fludarabine plus cyclophosphamide (Flu/Cy) with or without Genasense. This study - the only randomized controlled trial ever conducted in this population - achieved its intent-to-treat primary endpoint, which was a statistically significant increase in the proportion of patients who achieved a complete or nodular partial response (CR) (17% vs. 7%; P=0.025). By definition, CR represents the complete elimination of all clinical signs of leukemia, combined with the elimination of leukemia-related symptoms. In addition, the duration of CR - a prospectively specified and independent secondary endpoint -- was also significantly longer for patients treated with Genasense (median not yet reached but exceeding 36 months in the Genasense group compared with 22 months for patients treated with chemotherapy alone).

The data presented today are exploratory analyses based on extended follow-up of all pat
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SOURCE Genta Incorporated
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