Genta initiates new Phase 2 clinical trial of tesetaxel in patients with advanced prostate cancer

Genta Incorporated (OTCBB:GNTA) today announced that the Company has initiated a new Phase 2 clinical trial of tesetaxel in patients with advanced prostate cancer. Tesetaxel, the leading oral taxane in clinical development, will be evaluated for its use as both first- and second-line chemotherapy.

The new trial will be conducted through the Prostate Cancer Clinical Trials Consortium (PCCTC), which is comprised of 13 leading academic centers focused on prostate cancer research. Memorial Sloan-Kettering Cancer Center will act as the coordinating institution on behalf of the consortium and is the first site to open for enrollment.

In this study, two discrete populations will be evaluated: men who are hormone/castrate-resistant who have not previously received chemotherapy; and men who have developed progressive disease after having received at least 3 cycles of docetaxel chemotherapy.

A two-stage design will be employed for each cohort, and a maximum of 96 subjects are projected to be accrued. The primary endpoint is the estimation of the proportion of patients in each cohort who have not progressed for at least 6 months (i.e., 6-month progression-free survival). Accrual is expected to complete within 12 months.

Taxanes in Prostate Cancer Therapy

Two standard taxanes are currently approved in the U.S. for advanced prostate cancer. Docetaxel (Taxotere^®; sanofi aventis, Inc.) is approved for first-line use in chemotherapy-naive patients with castrate-resistant disease, and cabazitaxel (Jevtana^®; sanofi aventis, Inc.) is approved for patients who have progressed on docetaxel. However, standard taxanes are associated with substantial side effects, especially in older patients.

Unlike standard taxanes that must be administered intravenously, tesetaxel is a capsule that is taken by mouth. Compared with these drugs, 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