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Treatment for Chronic Lymphocytic Leukemia

Genta to Appeal FDA Decision on Genasense NDA

Genta to Appeal FDA Decision on New Drug Application for Genasense in Patients with Chronic Lymphocytic Leukemia

BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Dec 11, 2008 - Genta Incorporated announced that the Company has filed an appeal of the recent negative decision by the Food and Drug Administration's (FDA) Office of Oncology Drug Products (OODP) regarding the Company's New Drug Application (NDA) for Genta's lead oncology product, Genasense (oblimersen sodium) Injection. The NDA proposed the use of Genasense in combination with chemotherapy as treatment for patients with relapsed or refractory chronic lymphocytic leukemia (CLL).

"We believe our amended application provided evidence that amply documented the safety and effectiveness of Genasense for patients with CLL," said Dr. Raymond P. Warrell, Jr., MD, Genta's Chairman and Chief Executive Officer. "We look forward to promptly meeting with senior FDA leadership to formally review the key issues of this NDA."

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

About Genta

Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. Two major programs anchor the Company's research platform: DNA/RNA-based Medicines and Small Molecules. Genasense® (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genta is currently recruiting patients to the AGENDA Trial, a global Phase 3 trial of Genasense in patients with advanced melanoma. The leading drug in Genta's Small Molecule program is Ganite® (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration. The Company has developed G4544, an oral formulation of the active ingredient in Ganite, that has recently entered clinical trials as a potential treatment for diseases associated with accelerated bone loss. The Company is also developing tesetaxel, a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel. Ganite and Genasense are available on a "named-patient" basis in countries outside the United States. For more information about Genta, please visit our website at:


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. Such forward-looking statements include those that express plan, anticipation, intent, contingency, goals, targets, or future developments and/or otherwise are not statements of historical fact. The words "potentially", "anticipate", "could", "calls for", and similar expressions also identify forward-looking statements. The Company does not undertake to update any forward-looking statements. Factors that could affect actual results include, without limitation, risks associated with:

  • the Company's ability to obtain necessary regulatory approval for Genasense┬« from the U.S. Food and Drug Administration ("FDA");
  • 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, the Company's ability to obtain sufficient financing to maintain the Company's planned operations, or the Company's risk of bankruptcy;
  • the adequacy of the Company's patents and proprietary rights;
  • the impact of litigation that has been brought against the Company; 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.

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 2007 and its most recent quarterly report on Form 10-Q.

Contact: Genta Investor Relations

Posted: December 2008

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