Oncolytics Reolysin meets primary endpoint in first stage of Phase II SCCLC trial

17th September 2012 (Last Updated September 17th, 2012 18:30)

Oncolytics Biotech, a biotechnology company, has reported positive preliminary results from its US Phase II trial of Reolysin, intravenously administered in combination with carboplatin and paclitaxel in patients with squamous cell carcinoma of the lung (SCCLC).

Oncolytics Biotech, a biotechnology company, has reported positive preliminary results from its US Phase II trial of Reolysin, intravenously administered in combination with carboplatin and paclitaxel in patients with squamous cell carcinoma of the lung (SCCLC).

Patients with metastatic stage IIIB, stage IV, or recurrent squamous cell carcinoma of the lung, who are chemotherapy naïve for their metastatic or recurrent cancer, were treated in the first stage of two stage study.

If four or more patients demonstrated a partial response (PR) or better, the study would proceed to the second stage, with up to 55 patients being treated in the entire study.

Oncolytics president and CEO Dr Brad Thompson said the preliminary results are encouraging and further support the decision to undergo the study.

"Oncolytics Phase II program continues to grow and now includes randomised trials in six separate indications," Thompson said.

The endpoint was met after 15 evaluable patients were enrolled, and the company is proceeding with the second stage of the study.

Five of 15 patients showed PR, four confirmed, one unconfirmed, and an additional eight patients had stable disease, for a disease control rate of 87%.

The primary objective of the Phase II trial is to assess the antitumor effect of the treatment regimen in the study population in terms of objective response rates.

The secondary objectives include the assessment of progression-free survival and overall survival for the treatment regimen in the study population, to determine the proportion of patients receiving the above treatment who are alive and free of disease progression at six months and to assess the safety and tolerability of the treatment regimen in the study population.