Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The FDA has accepted Avantogen Oncology's investigational new drug application for RP101, a compound being investigated for the treatment of patients with pancreatic cancer.
Subscribe to our email newsletter
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.