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news.Genta 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.
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The company said that as a late Phase 2 oncology product, Tesetaxel is the leading oral taxane currently in clinical development.
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.
Reportedly, the endpoints of the study include response rate, durable response, disease control, progression-free survival, and safety.
Raymond Warrell, CEO at Genta, said: “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 US, 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.”