Systemic Administration of REOLYSIN® for Patients with Various Metastatic Tumors
In June 2007, Oncolytics announced positive results from its Phase I clinical trial to investigate the systemic delivery of REOLYSIN® as a treatment for patients with advanced or metastatic solid tumors. A total of eighteen patients were treated in the escalating dosage trial to a maximum daily dose of 3x1010 TCID50 in a one-hour infusion. Of the eighteen patients treated, eight demonstrated stable disease as measured by RECIST (Response Evaluation Criteria in Solid Tumors), including a patient with progressive breast cancer who experienced a 34% shrinkage in tumor volume. The treatment was well tolerated, and toxicities possibly related to REOLYSIN® were generally mild (Grade 1 or 2), including chills, fever and fatigue.
The primary objective of the study was to determine the maximum tolerated dose, dose-limiting toxicity and safety profile of REOLYSIN®. Secondary objectives included the evaluation of viral replication, immune response to the virus and any evidence of antitumor activity. The Principal Investigator for the Study was Dr. Sanjay Goel of the Montefiore Medical Center and the Albert Einstein College of Medicine in New York.
- June 5, 2007: Oncolytics Biotech Inc. Announced Positive Clinical Data from US Phase I REOLYSIN® Trial (Press Release)
- Dose Escalation and Pharmacodynamic Study of IV REOLYSIN®, A Proprietary Formulation of a Live Replication Competent RNA Virus in Patients with Advanced Solid Tumors (PDF)