Patients will be recruited for Phase II study of RP101 in the first quarter of 2007.
Avantogen Oncology’s IND has been accepted for RP101, a compound that has shown to increase the median survival rate of patients with pancreatic cancer. “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,” says Chris Nowers, CEO.
Avantogen plans 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. It will assess survival, with a primary efficacy endpoint at six months. Tumor response rate, progression-free survival, and safety will be evaluated as secondary endpoints. Patient accrual is currently targeted to begin early in 2007.
Standard chemotherapy typically offers patients with advanced pancreatic cancer a median survival of approximately six months. Two open-label, multicenter, Phase I trials indicated that RP101 in combination with standard chemotherapy in patients with advanced pancreatic cancer increased median survival to approximately 14 months and nine months.