Genta commences Phase 2 trial of tesetaxel on first subject

Feb 9 2010

Genta Incorporated (OTCBB: GETA) announced that the Company has initiated treatment of the first subject in a new Phase 2 trial of tesetaxel in advanced melanoma. 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 new trial builds on more than ten years of Genta’s experience in melanoma clinical research.

“Despite lack of regulatory approval, taxanes have been increasingly used for treatment of patients with metastatic melanoma”

Unlike standard taxanes (paclitaxel [Taxol®] or docetaxel [Taxotere®]) that must be infused intravenously, tesetaxel is a capsule that can be taken by mouth. The study will examine the effects of tesetaxel in patients with advanced melanoma who have developed progressive disease after treatment with a single first-line regimen. Endpoints of the study include response rate, durable response, disease control, progression-free survival, and safety. The study was initiated at M.D. Anderson Cancer Center in Houston, TX, which has been the lead center for Genta’s last two clinical trials in melanoma that together have enrolled approximately 1,100 patients.

“Despite lack of regulatory approval, taxanes have been increasingly used for treatment of patients with metastatic melanoma,” said Dr. Agop Bedikian, Professor of Medicine at M.D. Anderson Cancer Center and the new study’s Principal Investigator. “For patients who have failed first-line treatment, response rates – particularly durable responses – have been increasingly accepted as important clinical endpoints. Tesetaxel is a highly exciting and novel tubulin inhibitor with a pharmacokinetic profile that appears extremely promising. We are enthusiastic about being the lead center for this new endeavor.”

“Taxanes are the most widely used drug class in oncology,” commented Dr. Raymond P. Warrell, Jr., Genta’s Chief Executive Officer. “A successful oral taxane has been a research objective of many leading pharmaceutical companies. Our compound has been tested in preliminary studies involving more than 280 patients with various types of cancer in the U.S., Europe, and Japan. By eliminating serious hypersensitivity infusion reactions, as well as potentially reducing nerve damage and overcoming resistance to standard taxanes, tesetaxel may offer important new treatment options for patients with advanced cancer.”