BERKELEY HEIGHTS, N.J., April 4, 2012 (GLOBE NEWSWIRE) -- Genta Incorporated (OTCBB:GNTA) announced today that its lead compound, tesetaxel, will be featured in multiple presentations of new clinical data at the upcoming Annual Meeting of the American Society of Clinical Oncology (ASCO). The meeting will be held June 1-5, 2012, in Chicago, IL.
At the meeting, results from a confirmatory Phase 2 trial of tesetaxel, the leading oral taxane in clinical development, will be reported for overall response and progression-free survival (PFS) when used as 1st-line therapy for patients with hormone-refractory breast cancer. A second Phase 2 trial -- using tesetaxel as 2nd-line therapy for patients with advanced gastric cancer -- will report results on overall response and overall survival. A third presentation will report safety, pharmacokinetics, and the maximally tolerable dose (MTD) from a novel, weekly, dosing schedule. A final presentation will report data from a study of tesetaxel plus capecitabine (Xeloda®; Hoffmann La Roche, Inc.), a drug combination that will be featured in Genta's late-stage clinical trials.
Titles, dates, and times of these presentations appear below.
| Tesetaxel: activity of an oral taxane as first-line treatment in metastatic breast cancer. Abstract #1016 |
| Lead author: Andrew Seidman, MD, Memorial Sloan-Kettering Cancer Center |
| Poster Discussion Session: Breast Cancer - Triple-Negative/Cytotoxics/Local Therapy |
| Monday June 4, 2012; 1:15-5:45PM |
| Phase II trial of tesetaxel, an oral taxane, as second-line therapy for patients with advanced gastroesophageal cancer. Abstract 4077 |
| Lead author: Mary Mulcahy, MD, Northwestern University |
| General Poster Session: Gastrointestinal (Non-colorectal) Cancer |
| Monday June 4, 2012; 8AM-12N |
| Phase IB study of an all-oral chemotherapy regimen, tesetaxel plus capecitabine, in patients with advanced solid tumors. Abstract 3085 |
| Lead author: Michael G. Martin, MD, West Clinic, Memphis, TN |
| General Poster Session: Developmental Therapeutics - Experimental Therapeutics |
| Monday June 4, 2012; 8:00AM-12:00N |
| Phase I development of a weekly dosing schedule for the oral taxane tesetaxel. Abstract 2555 |
| Lead author: Amy Lang, MD, South Texas Accelerated Research Therapeutics |
| General Poster Session: Developmental Therapeutics - Clinical Pharmacology and Immunotherapy |
| Monday June 4, 2012; 8AM-1PM |
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. Genta is exclusively marketing Ganite® (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® that are being evaluated as potential treatments for diseases associated with accelerated bone loss. 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 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 2011 and its most recent quarterly report on Form 10-Q.