Today, Genta Inc. announced that the company has begun treatment of the first subject in a new Phase 2 trial of tesetaxel, used in relation to advanced melanoma. The study was initiated at the Anderson Cancer Center in Houston, TX, the lead center for Genta’s last two clinical trials in melanoma that have enrolled approximately 1,100 patients.
As a late Phase 2 oncology product, tesetaxel is the leading oral taxane currently in development. Unlike its competition, the tesetaxel capsule can be taken orally. The study will examine the effects of tesetaxel in patients with advanced melanoma who have already been treated with a single first-line regimen. Endpoints of the study include response rate, durable response, disease control, progression-free survival, and safety.
Dr. Agop Bedikian, professor of Medicine at M.D. Anderson Cancer Center and the new study’s Principal Investigator, stated, “Despite lack of regulatory approval, taxanes have been increasingly used for treatment of patients with metastatic melanoma. 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.”
Dr. Raymond P. Warrell, Jr., Genta’s Chief Executive Officer, added, “Taxanes are the most widely used drug class in oncology. 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.”