Tesetaxel is a new taxane that is administered by mouth as a capsule.
The drug was developed with a goal of maintaining high antitumor activity while eliminating infusion reactions, reducing neuropathy, and increasing patient convenience.
Tesetaxel Phase 2 study is designed to assess the efficacy and safety of the drug in patients with advanced bladder cancer who have developed progressive disease after treatment with a single 1st-line regimen, which is expected to be a combination of cisplatin plus gemcitabine (Gemzar; Eli Lilly).
Genta said that the Tesetaxel Phase 2 trial primary endpoint is overall response rate while the secondary endpoints include durable response, disease control, progression-free survival, and safety.
Furthermore, the dose for the new trial was determined from Genta’s ongoing studies in patients with advanced gastric cancer and advanced melanoma.
Genta chairman and CEO Raymond Warrell said that recently two companies terminated their programs with potentially competitive agents in this indication.
“Having observed preliminary activity in Phase 1, we wish to swiftly clarify the potential activity of tesetaxel in this disease that, if confirmed, could lead to registration-directed clinical trials,” Warrell said.
Tesetaxel Phase 2 trial is expected to be conducted at Memorial Sloan-Kettering Cancer Center, New York, the Kimmel Cancer Center at Jefferson University, Philadelphia, and at least one site in the EU.