Authorization For AGENDA Phase 3 Trial Of Genasense(R) In Advanced Melanoma Granted By French Regulatory Agency

Main Category: Melanoma / Skin Cancer
Also Included In: Cancer / Oncology;  Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials
Article Date: 18 Oct 2007 - 0:00 PDT

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Genta Incorporated (Nasdaq: GNTA) announced that the French Health Products Safety Agency ("AFSSAPS") has granted authorization to open the Company's Phase 3 trial of Genasense(R) (oblimersen sodium) Injection, its lead anticancer compound, in patients with advanced melanoma. This authorization enables the opening of approximately 13 new investigative sites over the next 2-4 weeks.

Genta's Phase 3 trial, known as AGENDA, is a randomized, double-blind, placebo-controlled study in which patients are randomly assigned to receive Genasense plus dacarbazine (DTIC) or DTIC alone. AGENDA will accrue approximately 300 patients and will be conducted at approximately 100 sites worldwide, including North America, Europe and Australia. Accrual, which is currently ongoing, is currently expected to complete in the fourth quarter of 2008.

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. The Company's research platform is anchored by two major programs: DNA/RNA-based Medicines and Small Molecules. Genasense(R) (oblimersen sodium) Injection is the Company's lead compound from its DNA/RNA Medicines program. Genta is currently recruiting patients for a global Phase 3 trial of Genasense in patients with advanced melanoma. The leading drug in Genta's Small Molecule program is Ganite(R) (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 an oral formulation of the active ingredient in Ganite that is currently undergoing initial clinical trials as a potential treatment for diseases associated with accelerated bone loss. Genta is partnered with IDIS (http://www.idispharma.com) on a program whereby both Ganite(R) and Genasense(R) are available on a "named-patient" basis in countries outside the United States. For more information about Genta, please visit our website at: http://www.genta.com.

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(R) from the U.S. Food and Drug Administration ("FDA") or European 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 and any proposed settlement of such litigation; 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 2006 and its most recent quarterly report on Form 10-Q.

Genta Incorporated
http://www.genta.com