As a result of the FDA decision a phase II study assessing RP101 combined with gemcitabine chemotherapy, versus gemcitabine chemotherapy alone, in patients with pancreatic cancer will proceed.
The previously announced study will have survival at 6 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.
Standard chemotherapy typically offers patients with advanced pancreatic cancer a median survival of approximately 6 months. In contrast, phase I trials indicated that RP101 in combination with standard chemotherapy was associated with a median survival of approximately 14 months and 9 months.