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Long-Term Followup in Phase 3 CLL Trial Shows Genasense(R) is Associated with Significantly Increased Survival in All Responders
Date:5/29/2008

New Data to be Presented at ASCO Shows Survival Benefit in Complete and

Partial Responders Compared with Chemotherapy Alone

BERKELEY HEIGHTS, N.J., May 29 /PRNewswire-FirstCall/ -- Genta Incorporated (OTC Bulletin Board: GNTA) announced the results of long-term followup from a Phase 3 trial of the Company's lead oncology product, Genasense(R) (oblimersen sodium) Injection, in patients with chronic lymphocytic leukemia (CLL). With 5 years of followup, new data show that patients who achieved either a complete response (CR -- the trial's primary endpoint) or a partial response (PR) have also achieved a statistically significant increase in overall survival. The data will be featured in an oral presentation at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago on June 2, 2008.

In the Phase 3 trial, 241 patients with relapsed or refractory CLL were randomly assigned to receive chemotherapy with fludarabine plus cyclophosphamide (Flu/Cy) with or without Genasense. This study achieved its primary endpoint, which was a statistically significant increase in the proportion of patients who achieved a complete or nodular partial response (CR) with the addition of Genasense to the Flu/Cy regimen. (17% vs. 7%; P=0.025). In addition, the median duration of CR was also significantly longer for patients treated with Genasense (median not reached but estimated to exceed 36 months vs. 22 months).

Previous analyses showed a significant benefit in overall survival accrued to patients who attained CR. Extended followup has shown that all major responses (CR+PR) achieved with Genasense have now been associated with significantly increased overall survival compared with all major responses achieved with chemotherapy alone (median = 56 months vs. 38 months, respectively). At 5 years, 22 of 49 (45%) responders in the Genasense group remain alive compared with 13 of 54 (24%) responders in the chemotherapy-only group (HR =
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SOURCE Genta Incorporated
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