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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

0.6; P = 0.038).

Moreover, with 5 years of follow-up, 12 of 20 patients (60%) in the Genasense group who achieved CR are alive, 5 of these patients remain in continuous CR without relapse, and 2 additional patients have relapsed but have not required additional therapy. By contrast, only 3 of 8 CR patients in the chemotherapy-only group are alive, all 3 have relapsed, and all 3 have required additional anti-leukemic treatment.

The Company has requested a meeting with the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA) to review this new information.

A scientific report of the initial safety and efficacy findings from this study was recently published (Journal of Clinical Oncology 25:1114, 2007).

About Chronic Lymphocytic Leukemia

CLL is the most common form of leukemia in adults. According to the American Cancer Society, approximately 8,000 patients will be diagnosed this year. More than 60,000 people in the U.S. currently have CLL. The disease arises in lymphocytes, a type of white blood cell that normally produces antibodies and serves important immune functions. Patients with CLL typically develop symptoms that may progress over a period of years, ultimately producing a generalized depression of immunity, marked increases in the size of spleen, liver and lymph nodes, and impaired production of other normal blood cells. Eventually, these problems may cause life-threatening complications, such as overwhelming infections and fatal bleeding. More information about CLL can be accessed at the website for the Lymphoma Research Foundation at: http://www.lymphoma.org .

About Genasense

Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current
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SOURCE Genta Incorporated
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