BERKELEY HEIGHTS, N.,J., April 26, 2011 (GLOBE NEWSWIRE) -- Genta Incorporated (OTCBB:GNTA) today announced that the Company has initiated a new clinical trial of tesetaxel in Japan as part of a comprehensive new initiative. Tesetaxel, the leading oral taxane in clinical development, will be evaluated over a limited dosing-range as a single agent in patients with advanced cancer. The new trial will be conducted at Kinki University in Osaka, which will enable the next generation of clinical studies in Japan.
Genta has indicated that gastric cancer is a key initial target for registration studies with tesetaxel. While gastric cancer is the fourth most common tumor type on a global basis, its incidence ranks either first or second in most East Asian countries, including Japan, Korea, Taiwan, and China.
"This study's initiation reflects Genta's extensive interactions with Japan's leading investigators and with the Pharmaceuticals and Medical Devices Agency (PMDA), the drug regulatory authority in Japan", said Dr. Loretta M. Itri, Genta's President, Pharmaceutical Development, and Chief Medical Officer. "We anticipate conducting substantial additional work throughout Japan and East Asia as activity in the tesetaxel development program continues to accelerate."
About Tesetaxel
Unlike standard taxanes that must be administered intravenously, tesetaxel is a capsule that is taken by mouth. Compared with the standard agents, clinical and preclinical data show that tesetaxel:
- Is active in diseases that are resistant to standard taxanes
- Is not associated with serious (occasionally fatal) hypersensitivity reactions
- Eliminates requirements for premedication (e.g., steroids, antihistamines, etc.)
- Reduces damage to peripheral nerves
- Offers flexible and convenient dosing for patients
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 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® 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 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® that are being evaluated as potential treatments for diseases associated with accelerated bone loss. 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: .
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.
CONTACT: Genta Investor Relations info@genta.com Media Contact 908-286-3980