Based on the safety profile and the ability to deliver planned doses of gemcitabine in combination with RP101, an RP101 dose of 750mg/day has been selected to be taken into the planned randomized, placebo controlled, phase II study. Altogether, five dose levels of RP101 were evaluated in the study: 500, 625, 750, 875 or 1000mg/day.
According to the company, preliminary analysis of survival data from the study indicates an estimated median survival of 9.3 months which compares favorably to a median survival of approximately six months seen in several recent large randomized studies evaluating gemcitabine monotherapy and gemcitabine in combination with erlotinib or oxaliplatin.
Adverse events were generally consistent with those experienced by patients with advanced pancreatic cancer undergoing gemcitabine chemotherapy. Neutropenia, nausea, vomiting, loss of appetite, fatigue and fever being those most commonly observed.