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     CHRONIC LYMPHOCYTIC LEUKEMIA

 

GENASENSE

                                                  It Could be Good News For the Drug

     We have comforting news from GENTA (GNTA). The good news comes with the presentation of new analyses from the randomized Phase 3 trial of Genasense® (oblimersen sodium) in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). In patients who were prospectively stratified as being "non- refractory," Genasense-treated patients were four times more likely to achieve complete remission compared with patients treated with chemotherapy alone. Moreover, these non-refractory patients also achieved a statistically significant increase in overall survival.

      The analyses comprised information submitted by Genta to the U.S. FDA last month. Highlights of these data were presented by Dr. Kanti R. Rai, Chief, Hematology and Oncology, North Shore/Long Island Jewish Medical Center, and Professor of Medicine, Albert Einstein College of Medicine, at the 24th Annual Symposium of the Chemotherapy Foundation in New York.

 

      In the Phase 3 trial, 241 patients with relapsed or refractory CLL were randomly assigned to receive fludarabine plus cyclophosphamide (Flu/Cy) chemotherapy with or without Genasense. This trial 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). In addition, the duration of CR/nPR was significantly longer for patients treated with Genasense (median = not reached but exceeding 36+ mos. in the Genasense group vs. 22 mos. for patients treated with chemotherapy alone).

      Prior to randomization on this trial, patients were prospectively stratified according to three criteria that reflected their responsiveness to prior chemotherapy. The CR/nPR response to Flu/Cy alone was both equally poor (6-7%) and numerically inferior in all stratification groups. Nonetheless, clear trends were evident across all strata, which suggested the best response to Genasense was achieved in patients who had received less extensive therapy.

Patients who were protocol-defined as "non-refractory" to fludarabine comprised more than 40% of the total population. In non-refractory patients, the Genasense group compared with the chemotherapy-only group achieved:

    -- A four-fold increase in CR/nPR (25% [13/51] vs. 6% [3/50]; P = 0.016)    -- Increased time-to-progression (median = 12 mos. vs. 10 mos.; P = N.S.)   -- Increased overall survival (median not reached but exceeding 39+ mos.       vs. 33 mos.; P = 0.05)

      Similar trends were observed in the two other strata (i.e., patients who received 1-2 prior regimens, and patients whose response to last therapy was longer than 6 months).

"The Genasense Phase 3 trial met its intent-to-treat primary endpoint across the entire population of relapsed/refractory patients. However, these data clearly define a prospectively specified population that derived maximal benefit from adding Genasense to conventional chemotherapy," commented Dr. Loretta M. Itri, Genta's President, Pharmaceutical Development, and Chief Medical Officer "We are pleased that FDA is taking the additional time to thoughtfully examine these and other new analyses. Together with the community of CLL physician specialists and patients, we look forward to continuing our dialog with the Agency on the pending New Drug Application in CLL."

 

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 anticancer treatment. Genta is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer.

 

Safe Harbor

 

      This press release may contain forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Forward- looking statements include, without limitation, statements about:

    -- the company's ability to obtain necessary regulatory approval for  Genasense® from the U.S. Food and Drug Administration ("FDA") orEuropean Medicines Agency ("EMEA"); -- the safety and efficacy of the company's products or product       candidates;  -- the company's assessment of its clinical trials;  -- the commencement and completion of clinical trials;   -- the company's ability to develop, manufacture, license and sell its products or product candidates;  -- the company's ability to enter into and successfully execute license and collaborative agreements, if any;  -- the adequacy of the company's capital resources and cash flow       projections, and the company's ability to obtain sufficient financing       to maintain the company's planned operations;    -- the adequacy of the company's patents and proprietary rights; -- the impact of litigation that has been brought against the company and       its officers and directors;    -- the Company's ability to regain compliance with the NASDAQ's listing       qualifications; and -- the other risks described under Certain Risks and Uncertainties Related       to the company's Business, as contained in the company's Annual Report on Form 10-K and Quarterly Report on Form 10-Q.

     The company does not undertake to update any forward-looking statements. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the company's Annual Report on Form 10-K for 2005 and its most recent quarterly report on Form 10-Q.

CONTACT: Tara Spiess/Andrea Romstad TS Communications Group,LLC  info@genta.com                   (908) 286-3980

 

  



 



 
   

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