Genta Incorporated has initiated a new dose-ranging study of tesetaxel, the company’s novel oral tubulin inhibitor, using a weekly dosing regimen. Tesetaxel -- a late phase-2 oncology product -- is the leading oral taxane currently in clinical development.

Genta has recently completed a dose-ranging and pharmacokinetic study using tesetaxel administered once every three weeks, a schedule that has shown anticancer activity in several phase-2 clinical trials. This schedule has been extensively evaluated in a series of phase-1 and phase-2 trials that together have enrolled more than 280 patients. Data from the recently completed study of the once-every-three-week schedule have confirmed safety findings previously reported for this regimen, and the results have been submitted for presentation to the annual meeting of the American Society of Clinical Oncology (ASCO) that is scheduled in June 2010. The new trial is the first clinical study to test an alternative dosing regimen in which the drug will be administered once weekly for three consecutive weeks, followed by one week off treatment. The goal of the study will be to establish safety and a suitable dose for extended testing in late-stage clinical trials.

“Weekly dosing schedules of other taxanes have been increasingly incorporated into so-called “dose dense” chemotherapy programmes, particularly in breast cancer,” commented Dr Loretta M Itri, Genta’s president, Pharmaceutical Development, and chief medical officer. “Since the activity of certain taxanes may be schedule-dependent, we plan to evaluate both dosing regimens to ensure we have maximized the potential efficacy and safety of tesetaxel in our late-stage clinical programs.”

Tesetaxel is a novel, orally absorbed, semi-synthetic taxane that is in the same class of drugs as paclitaxel and docetaxel.