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 2nd-line treatment
of patients with advanced gastric cancer (see results below) and will
enroll patients who have progressed on a single 1st-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.