Genta commences Phase 2b trial of tesetaxel in patients with advanced gastric cancer

Mar 31 2010

Genta Incorporated (OTCBB: GETA) today announced that the Company has initiated a confirmatory Phase 2b trial of tesetaxel in patients with advanced gastric cancer. Tesetaxel is the Company's newest clinical-stage small molecule. As a late Phase 2 oncology product, tesetaxel is the leading oral taxane currently in clinical development. The trial is currently open to enrollment at Northwestern University, Chicago, IL, which will be joined by M.D. Anderson Cancer Center in Houston, TX and several additional sites.

“While several taxanes are approved as agents for 1st-line treatment of gastric cancer, most actual use in practice is as 2nd- or 3rd- line therapy due to their toxicity”

The new trial is designed to confirm the efficacy results observed in a preliminary Phase 2a study of tesetaxel as 2^nd-line treatment of patients with advanced gastric cancer (see results below) and will enroll patients who have progressed on a single 1^st-line chemotherapy regimen. Unlike conventional taxanes (paclitaxel [Taxol^®] or docetaxel [Taxotere^®]) that must be infused intravenously, tesetaxel is a capsule that is taken by mouth. Endpoints of the new Phase 2b study include response rate, durable response, disease control, progression-free survival, and safety. The dose for the new trial was determined from Genta's recently completed dose-ranging and pharmacokinetic study, whose results have been accepted for presentation at the upcoming annual meeting of the American Society of Clinical Oncology (ASCO) in June 2010.

"While several taxanes are approved as agents for 1^st-line treatment of gastric cancer, most actual use in practice is as 2^nd- or 3^rd- line therapy due to their toxicity," said Dr. Raymond P. Warrell, Jr., Genta's Chairman and Chief Executive Officer. "Patients who progress on 1^st-line treatment have a poor prognosis, and the side-effects of standard taxanes in this setting are an important issue in clinical care. By eliminating serious hypersensitivity infusion reactions, as well as potentially reducing nerve damage and overcoming resistance to conventional taxanes, tesetaxel may offer important new treatment options for patients with gastric cancer. We look forward to rapidly confirming the initial promising data and progressing to pivotal trials that may enable global registration."