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FDA Indicates That Genasense(R) Approval in Chronic Lymphocytic Leukemia Will Require Additional Confirmatory Data
Date:3/17/2008

ed as "non-refractory" (N=101), who are the focus of the proposed trial, the CR rate was 25% (13 of 51) in the Genasense group compared with 6% (3 of 50) in the Flu/Cy-only group (P=0.016). Extended followup has also demonstrated superior survival for patients who achieved CR in the Genasense group.

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

Conference Call

Genta management will further discuss the current status and forward strategy for Genasense in CLL in a conference call and webcast on Tuesday March 18, 2008 at 8:30 AM EDT. Participants can access the live call by dialing (877) 634-8606 (U.S. and Canada) or (706) 679-3140 (International). The access code for the live call is Genta Incorporated, conference ID number 39856497. The call will also be webcast live at http://www.genta.com/investorrelation/events.html.

For investors unable to participate in the live call, a replay will be available approximately two hours after completion of the call, and will be archived for 30 days. Access numbers for this replay are: (800) 642-1687 (U.S. and Canada) and (706) 645-9291 (International); conference ID number is: 39856497.

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.
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