-- TESEGAST Trial Opens in U.S., EU, and Asia
-- Double-Blind Study Uses "All Oral" Chemotherapy Regimen as 2nd-Line Treatment
BERKELEY HEIGHTS, N.J., May 8, 2012 (GLOBE NEWSWIRE) -- Genta Incorporated (OTCBB:GNTA) announced today that the first patient has been accrued to a new randomized clinical trial of its lead compound, tesetaxel, in patients with advanced gastric cancer. The trial, known as TESEGAST, is a randomized, double-blind, placebo-controlled study that is expected to accrue approximately 260 patients. The trial will be conducted at approximately 40 sites worldwide, including the U.S., Western Europe, and Asia. Accrual is projected to take approximately 12-15 months, with approximately 9 months of followup after the last patient is randomized.
The trial will enroll patients with advanced gastric cancer who have measurable disease that has progressed after initial chemotherapy. Prior treatment must have included a platinum-containing drug and a fluoropyrimidine. Testing for HER2 expression is required; HER2+ patients must have received and progressed on trastuzumab (Herceptin®; Hoffmann La Roche, Inc.). In this "all-oral" chemotherapy program, eligible patients will receive capecitabine (Xeloda®; Hoffmann La Roche, Inc.) and will be randomly assigned to receive capsules of tesetaxel or placebo. The primary endpoint of the trial is overall survival; secondary endpoints include overall response, progression-free survival, and safety.
"TESEGAST builds on our experience in two Phase 2a studies and more than 80 patients treated with tesetaxel as 2nd-line therapy for advanced gastric cancer," said Dr. Loretta M. Itri, Genta's President and Chief Medical Officer. "We are pleased with the outcome of extensive discussions with regulatory authorities in all territories that are involved with the trial."
"Intravenous taxanes are frequently used to treat patients with advanced gastric cancer; however, allergic reactions occur frequently and neutropenia is common," said Dr. Jaffer Ajani, Professor of Medicine at the M.D. Anderson Cancer Center, Houston, TX, who is the global Principal Investigator for TESEGAST. "Our Phase 2 experience as 2nd-line therapy for patients with advanced gastric cancer showed that the response rate from tesetaxel has equaled or exceeded that of docetaxel in this patient population. I am excited to initiate the first randomized trial to observe whether the promising response rate to tesetaxel will translate into a survival benefit for our 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 registration. 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.
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