Oncolytics completes enrollment in cancer combination therapy study

Oncolytics Biotech, a biopharmaceutical company, has completed patient enrollment in its UK clinical trial to evaluate the anti-tumor effects of intravenous administration of Reolysin in combination with gemcitabine in patients with advanced cancers including breast, and head and neck.

The UK trial (Reo 009) is an open-label, dose-escalating, non-randomized study of Reolysin given intravenously with gemcitabine every three weeks. Gemcitabine (1000mg/m2) was administered to patients in combination with escalating dosages of Reolysin intravenously.

Eligible patients included those who had been diagnosed with advanced or metastatic solid tumors including pancreatic, lung and ovarian cancers that are refractory to standard therapy or for which no curative standard therapy exists.

The primary objective of the trial was to determine the maximum tolerated dose, dose-limiting toxicity, recommended dose and dosing schedule and safety profile of Reolysin when administered in combination with gemcitabine.

A total of 15 patients were enrolled in the trial. Of the 10 patients evaluable for response, two patients had partial responses (PR) and five patients had SD (stable disease) for four to eight cycles, for a total disease control rate (CR (complete response)+PR +SD) of 70%.

Brad Thompson, president and CEO of Oncolytics, said: The results to date using this treatment combination in late-stage cancer patients indicate that further studies using this drug combination are warranted. We plan to initiate further studies in the US using a modified dosage regime of Reolysin and the commonly used US dosage of gemcitabine (800mg/m2) in patients with advanced or metastatic pancreatic cancer in partnership with the Cancer Therapy & Research Center at The University of Texas Health Science Center in San Antonio.