FDA accepts' Avantogen's IND for RP101

Los Angeles, USA-based Avantogen Oncology says that the Food and Drug Administration has accepted its Investigational New Drug application for RP101, a compound being investigated for the treatment of patients with pancreatic cancer.

As a result of the FDA decision, a Phase II randomized, double-blind, placebo-controlled study assessing RP101 combined with gemcitabine chemotherapy, versus gemcitabine chemotherapy alone, in patients with metastatic pancreatic cancer will proceed. The previously-announced study will have survival at six months as the primary efficacy endpoint, while tumor response rate and progression-free survival will be evaluated as secondary endpoints, along with safety. Patient accrual is currently targeted to begin early in 2007.

"This important IND approval enables us to move RP101 to the next stage of clinical development and progress its assessment as a meaningful therapeutic for patients with pancreatic cancer," said Chris Nowers, chief executive.