Genta Incorporated (OTCBB: GNTA.OB) today announced that the Company has initiated a new Phase 2b clinical trial of tesetaxel as 1st-line chemotherapy for women with metastatic breast cancer. Tesetaxel is the leading oral taxane currently in clinical development. The new trial will be conducted at Memorial Sloan-Kettering Cancer Center, New York, NY and at the Accelerated Community Oncology Research Network (ACORN) based in Memphis, TN.
The new trial is designed to confirm and extend the efficacy and safety results observed in a preliminary Phase 2a study of tesetaxel as 2nd-line treatment of patients with advanced breast cancer (see results below). The new study includes women with Her2-negative breast cancer who have developed progressive disease after primary surgery but who have not previously received chemotherapy for metastatic disease. Patients who received adjuvant post-operative chemotherapy (that may have included a taxane) are also eligible if they have been disease-free for at least 12 months since the last dose of chemotherapy.
The primary endpoint of the study is percent overall response. Secondary endpoints include response duration, disease control at 3 months, percent progression-free survival (PFS) at 6 months, durable response ≥ 6 months, and time-to-progression (TTP). A total of 25 patients are expected to be accrued, and enrollment should be completed in 2011.
Unlike conventional taxanes (paclitaxel [Taxol®] or docetaxel [Taxotere®]) that must be infused intravenously, tesetaxel is a capsule that is taken by mouth. Compared with standard taxanes, clinical and preclinical data show that tesetaxel:
- Eliminates serious (occasional fatal) hypersensitivity reactions
- Eliminates requirements for premedication (e.g., steroids, antihistamines, etc.)
- Reduces damage to peripheral nerves
- Is not cross-resistant with standard taxanes
- Offers flexible and convenient dosing for patients