REO 021

Intravenous Administration of REOLYSIN® in Combination with Paclitaxel and Carboplatin for Patients with Squamous Cell Carcinoma Lung Cancer

In March 2010, Oncolytics announced that the Cancer Therapy and Research Center at the University of Texas Health Science Center had started patient enrollment in a US Phase II clinical trial using intravenous administration of REOLYSIN^® in combination with carboplatin and paclitaxel in patients with squamous cell carcinoma of the lungs (SCC lung cancer).
 
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 are to assess 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.

In September 2012, the Company announced that it had met the primary endpoint for the first stage of the study. Up to 19 evaluable patients with SCC lung cancer were to be treated in the first stage. If four or more patients demonstrated a partial response (PR) or better, the study would then proceed to the second stage, with up to 55 patients being treated in the entire study. This endpoint was met after 15 evaluable patients were enrolled.  Five of 15 patients showed PR, four confirmed, one unconfirmed, and an additional eight patients had stable disease (SD), for a disease control rate (complete response (CR) + PR + SD)) of 87%.  The Company is now proceeding with the second stage of the study.
 
 
Links:

• March 28, 2013: Oncolytics Biotech® Meets Primary Overall Statistical Endpoint in U.S. Phase 2 Study of REOLYSIN® in Squamous Cell Lung Cancer 

• Feb 8, 2013: Oncolytics Biotech® Announces Additional Positive REOLYSIN® Clinical Trial Data from Phase 2 Study in Squamous Cell Carcinoma of the Lung 

• September 13, 2012: Oncolytics Biotech Inc. Meets Primary Endpoint for First Stage of US Phase 2 Squamous Cell Lung Cancer Clinical  Trial (Press Release)

• March 30, 2010: Oncolytics Biotech Inc. Announces Start of Enrollment in US Phase II SCC Lung Cancer Trial (Press Release) 

• REO 021 on ClinicalTrials.gov (External Link)