GENTA (GNTA)Tesetaxel is the leading oral taxane in clinical development. The trial is lead by Memorial Sloan-Kettering Cancer Center, New York, NY, in collaboration with three other U.S. centers.
"These data confirm results from our prior study, both of which show substantial activity for tesetaxel in patients with advanced, HER2-negative breast cancer", said Dr. Loretta M. Itri, Genta's President, Pharmaceutical Development, and Chief Medical Officer. "Genta is also exploring an alternate dosing schedule in this population using weekly treatment. Based on this favorable experience, and after conferring with regulatory authorities in the U.S. and EU, Genta plans to proceed with a new randomized trial of tesetaxel as initial, single-agent chemotherapy for patients with recurrent breast cancer."
Genta Incorporated (GNTA) announced results from the Company's Phase 2, confirmatory, clinical trial of tesetaxel as 2nd-line treatment of patients with advanced gastric cancer. The trial was conducted at M.D. Anderson Cancer Center, Houston, TX, in collaboration with Northwestern University, Chicago, IL, the University of Pennsylvania, Philadelphia, PA, and the Severance Hospital, Seoul, Korea.
"With this study, Genta has completed an extensive Phase 2 evaluation of tesetaxel as 2nd-line treatment in a total of 88 patients with advanced gastric cancer," said Dr. Loretta M. Itri, Genta's President, Pharmaceutical Development, and Chief Medical Officer. "Our data confirm the activity of tesetaxel in gastric cancer at a level that is at least equivalent to docetaxel, but with an improved safety profile. Results from this new study support projections for overall survival in our randomized trial. We look forward to accelerating recruitment to this new multinational study."
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
Thus, tesetaxel offers substantial opportunities to improve patient convenience, safety, and anticancer activity.
Genta is conducting a multinational, randomized, double-blind trial that compares capecitabine with tesetaxel or placebo in patients with 2nd-line gastric cancer.
