Oncolytics Biotech announced interim data from its Phase 2 study of Reolysin in combination with Gemzar (gemcitabine; Eli and Lilly) in patients with advanced pancreatic cancer. In the first stage of this one-sample, two-stage study design, 17 patients were to be enrolled. If <3 responses (defined as complete reponse (CR) or partial response (PR) or stable disease (SD) for ≥12 weeks) were observed, the study would have concluded that the combination was inactive and been terminated. If ≥3 responses were observed among the 17 patients, the study would enroll 16 more patients, for a total of 33 evaluable patients.
To date, the study has successfully reached its primary endpoint demonstrated through 8 of 13 evaluable patients having SD for ≥12 weeks, for a clinical benefit rate (CR + PR + SD) of 62%. An additional patient had an unconfirmed PR of <6 weeks. This data confirms that the drug combination is active.
Reolysin is a formulation of the human reovirus designed to replicate specifically in tumor cells bearing an activated Ras pathway. Activating mutations of Ras and upstream elements of Ras may play a role in greater than two-thirds of all human cancers.
For more information call (403) 670-7377 or visit www.oncolyticsbiotech.com.