Genta Announces Clinical Presentations on Lead Compounds, Tesetaxel and Genasense, at 2011 Annual ASCO Meeting
BERKELEY HEIGHTS, NJ – May 17, 2011 – Genta Incorporated (OTC: GNTA.OB) today announced that data from clinical trials of the Company's late-stage compounds, Genasense® (oblimersen sodium) Injection and tesetaxel, will be presented at the 2011 annual meeting of the American Society of Clinical Oncology (ASCO). The meeting will be held from June 3-7 in Chicago, IL.
Highlights of the presentations include final results, including overall survival and durable response rate, from AGENDA -- the Phase 3 trial of Genasense® in advanced melanoma. In addition, final survival results from a trial in advanced melanoma that combined Genasense® plus temozolomide and Abraxane® will be presented, including data from patients who received Genasense as a 1-hour, twice-weekly, intravenous infusion.
Reports on clinical trials using tesetaxel, the leading oral taxane in clinical development, will also be presented, including Phase 2 studies as 1st-line therapy for patients with hormonerefractory breast cancer and as 2nd-line therapy using a flat (non weight-based) dose in patients with advanced gastric cancer. Additional reports include results of a clinical study that showed no effect of food on tesetaxel pharmacokinetics, which has eliminated overnight fasting requirement s prior to dosing.
Titles, dates, and times of these presentations appear below.
Survival in a Phase 3, randomized, double-blind study of dacarbazine with or without oblimersen (Bcl-2 antisense) in patients with advanced melanoma and low-normal serum lactate dehydrogenase (LDH) (AGENDA). Abstract #8531. Poster Session: Monday, June 6, 2011 8:00 AM-12:30 PM; Discussion Session 11:30 AM-12:30 PM.
Dose-ranging study of tesetaxel, a novel oral taxane, administered as second-line therapy at a flat dose to patients with advanced gastric cancer. Abstract #4110. General Poster Session: Saturday, June 4, 2011 8:00 AM–12:00 PM Abraxane, temozolomide and oblimersen (The ATG Trial): A final report of toxicity and clinical efficacy in metastatic melanoma patients with normal lactate dehydrogenase (LDH). Abstract #8545. General Poster Session: Sunday, June 5, 2011 8:00 AM–12:00 PM Tesetaxel, an advanced-generation oral taxane, as first-line treatment in women with metastatic breast cancer. Abstract #TPS123. Trials in Progress Poster Session: Monday, June 6, 2011 8:00 AM-12:00 PM Clinical evaluation of food effects on pharmacokinetics of the novel oral taxane, tesetaxel.
Abstract #e13059. Electronic publishing.
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® (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® in patients with advanced melanoma, known as “AGENDA”. Survival data from AGENDA are projected to be available in May 2011. 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. Ganite® and Genasense® are available on a “named-patient” basis in countries outside the United States.
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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.
Posted: May 2011