ACT Biotech has submitted Special Assessment (SPA) with the US Food and Drug Administration (FDA) for a multi-center, double-blind, randomized Phase 3 trial of Telatinib.
Reportedly, the Phase 3 Telatinib trial will compare Telatinib in conjunction with a standard regimen of chemotherapy versus chemotherapy alone in advanced stomach cancer patients.
ACT Biotech said that if the Phase 3 trial analysis agreed upon in the SPA is positive, the data would then provide the basis for the filing of a US new drug application (NDA) for marketing approval of Telatinib for the treatment of metastatic stomach cancer.
ACT Biotech chief operating and scientific officer Ali Fattaey said the patient benefit observed from telatinib treatment in the recently completed Phase 2 trial in the same patient population with the same chemotherapy regimen compelled us to advance rapidly into a registration program.
"Rapid objective tumor responses in two thirds of patients, strong evidence of antiangiogenic activity, an increase in survival over historical controls, and excellent safety in combination with chemotherapy all suggest that Telatinib could become an important option for patients with this deadly disease," Fattaey said.