Healthcare Industry News: Ganite
News Release - August 18, 2006
Genta Revises Notice of Special Protocol Assessment for Confirmatory Trial of Genasense(R) Plus Chemotherapy in Chronic Lymphocytic LeukemiaBERKELEY HEIGHTS, N.J., Aug. 18 (HSMN NewsFeed) -- Genta Incorporated (Nasdaq: GNTA) announced that the Company has received communication from the Food and Drug Administration (FDA) that FDA has not yet completed its review of the Company's proposal for a confirmatory trial of Genasense(R) (oblimersen sodium) Injection in patients with chronic lymphocytic leukemia. The request for Special Protocol Assessment was submitted in December 2005. Pursuant to the Company's press release dated July 26, 2006, Genta believes that it has revised its proposal to fully address all issues that had been identified by FDA. Genta is working with FDA to clarify any issues that may remain outstanding prior to initiation of the trial.
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 that center on oligonucleotides (RNA- and DNA- based medicines) and small molecules. Genasense(R) (oblimersen sodium) Injection is the Company's lead compound from its oligonucleotide program. The Company has submitted a New Drug Application (NDA) to the Food and Drug Administration for the use of Genasense plus fludarabine and cyclophosphamide for treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Genta has also completed a Marketing Authorization Application to the European Medicines Agency (EMEA) for use of Genasense plus dacarbazine for treatment of 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. For more information about Genta, please visit our website at: http://www.genta.com.
This press release contains 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;
* the commencement and completion of clinical trials;
* the Company's ability to develop, manufacture and sell its products;
* the adequacy of the Company's capital resources 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 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.
Source: Genta Inc
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