REO 001 was an open-label, dose-escalation Phase I study of REOLYSIN® in patients with advanced subcutaneous tumours, including those with primary breast and head and neck cancer, melanoma and sarcoma, who had failed to respond to conventional therapies. A total of eighteen patients were enrolled, each receiving a single, Intratumoural injection of REOLYSIN® at increasing dosages. The primary objectives of the study were to determine dose-limiting toxicities and maximum tolerated dose. The secondary objective was tumour response.
The Company announced final results from the study in March 2002. None of the patients receiving REOLYSIN® experienced any serious adverse events related to the virus, nor were there any dose limiting toxicities detected in any patient. Tumour responses were measured at both the treated lesion and remote tumour sites. Viral activity was defined as a transitory or lasting tumour regression of at least 30% measured in two dimensions against the tumour size prior to injection on the first day of treatment. Evidence of viral activity was detected in 11 of 18 patients (61%), with tumour regression ranging from 32% to 100%.