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Old 02-15-2007, 03:11 PM
Dross Dross is offline
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Default Genta Cites Publication of Study Showing Improved Outcomes in CLL Patients Treated Wi

A new story entry has been added:

Genta Cites Publication of Study Showing Improved Outcomes in CLL Patients Treated With Genasense(R) Plus Chemotherapy

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BERKELEY HEIGHTS, N.J., Feb. 14 -- [B]Genta Incorporated [/B](NASDAQ:GNTA) today announced the publication of findings from a Phase 3 trial of the Company's lead anticancer drug, Genasense(R) (oblimersen sodium) Injection, when used in combination with chemotherapy for treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL). The findings were published on-line this week in the Journal of Clinical Oncology, ahead of its tentatively scheduled print publication date of March 20, 2007. Conducted at 100 centers in the U.S., Europe, Canada, Australia and South America, patients with relapsed or refractory CLL received fludarabine plus cyclophosphamide (Flu/Cy) chemotherapy with or without Genasense. This trial -- the first randomized study ever conducted in this population -- achieved its primary endpoint, which was a statistically significant increase in the proportion of patients who achieved a complete or nodular partial response (CR/nPR) (17% vs. 7%; P=0.025). Patients who achieved CR/nPR experienced the disappearance of all predefined CLL symptoms, including fever, night sweats, fatigue, abdominal discomfort due to an enlarged spleen, and impaired mobility due to swollen lymph nodes. The key secondary endpoint -- duration of CR/nPR -- was also significantly longer for patients treated with Genasense (median = not reached but will exceed 36 months in the Genasense group vs. 22 months for patients treated with chemotherapy alone). Among patients who achieved a CR/nPR with Genasense, 70 percent were alive at three years versus 38 percent for the control arm. Among patients who achieved a partial response, 45 percent who received Genasense were alive at three years compared to 33 percent for the control arm. The lead and senior authors of the article are, respectively, Dr. Susan O'Brien, Professor of Medicine, Department of Leukemia, M.D. Anderson Cancer Center, and Dr. Kanti R. Rai, Chief, Hematology and Oncology, North Shore/Long Island Jewish Medical Center, and Professor of Medicine, Albert Einstein College of Medicine. An abstract of this article that addresses safety and efficacy in the trial can be accessed at:
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