Genta Incorporated (OTCBB:GNTA - News) today updated its formal guidance for release of results from its Phase 3, randomized, controlled trial of Genasense(R) (oblimersen sodium) Injection in patients with advanced melanoma, also known as the AGENDA trial. After completion of final data collection, transfer and locking of the database, and statistical analysis, the Company expects to release a "top-line" statement regarding the result for overall survival in May 2011. The data collection process for this double-blind trial has not yet been completed.
A more extended analysis of efficacy and safety from AGENDA will be presented at the annual meeting of the American Society of Clinical Oncology (ASCO) in June 2011. A provisional abstract regarding AGENDA -- which has indicated only that results for the late endpoints of overall survival and durable response would be available -- has been accepted for presentation at the meeting.
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 is developing tesetaxel, a novel, orally absorbed taxane that is in the same class of drugs as paclitaxel and docetaxel. As the leading oral taxane in clinical development, tesetaxel has been evaluated in a broad program of completed or ongoing Phase 2a/Phase 2b clinical trials. The Company has announced that gastric (stomach) cancer will be the lead indication for Phase 3 registration studies. Genasense(R) (oblimersen sodium) Injection is a modified DNA-based antisense drug that may enhance the effectiveness of anticancer therapy. Genta has completed enrollment in a randomized, double-blind Phase 3 study of Genasense(R) in patients with advanced melanoma, known as "AGENDA". Survival data from AGENDA are projected to be available in the second quarter of 2011. Genta is exclusively marketing Ganite(R) (gallium nitrate injection) in the U.S., which is indicated for treatment of symptomatic patients with cancer-related hypercalcemia that is resistant to hydration. The Company has developed proprietary oral formulations of the active ingredient in Ganite(R) that are being evaluated as potential treatments for diseases associated with accelerated bone loss. 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: 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. 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 its product candidates from regulatory agencies, such as the U.S. Food and Drug Administration and the European Medicines Agency; * the safety and efficacy of the Company's products or product candidates; * the timing of commencement and completion of any clinical trials; * the Company's assessment of its clinical trials; * the Company's ability to develop, manufacture, license, or sell its products or product candidates; * the Company's ability to enter into and successfully execute any license and collaborative agreements; * 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 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 2010 and its most recent quarterly report on Form 10-Q.
( Sources Genta Incorporated)
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