Oncolytics Biotech has reported positive preliminary results from a Phase II clinical trial evaluating the intravenous administration of Reolysin in combination with gemcitabine (Gemzar) as a treatment for patients with advanced pancreatic cancer.
The single arm and open-label study planned to enrol 17 patients with advanced or metastatic pancreatic adenocarcinoma who had measurable disease and had not received any prior chemotherapy or biotherapy.
If three or more patients received clinical benefit, the study would then proceed to the next stage.
The endpoint was achieved after six evaluable patients were enrolled, and all the patients treated reported symptomatic improvement.
The study’s primary objective is to establish the clinical benefit rate (complete response, partial response and stable disease) of Reolysin.
The secondary objectives are to establish progression-free survival, and the safety and tolerability of Reolysin in combination with gemcitabine.
The company is planning to complete enrolment in the first stage of the study and then continue with further studies.