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The primary statistical endpoint of the trial was met in late 2008. To meet the endpoint, at least three out of 52 patients had to experience stabilization of disease or better for more than six months.
Of the 33 patients evaluable at that time, five had experienced stable disease for periods greater than six months, including one patient who had maintained stable disease for more than 16 months. An additional 10 patients had experienced stable disease for periods ranging from three to six cycles (cycle = 28 days).
The trial (REO 014) is a Phase II, open-label, single agent study whose primary objective is to measure tumor responses and duration of response, and to describe any evidence of antitumor activity of intravenous, multiple dose Reolysin in patients with bone and soft tissue sarcomas metastatic to the lung.
Monica Mita, principal investigator at the institute of drug development, the Cancer Therapy & Research Center at the University of Texas Health Science Center, San Antonio, Texas, said: "We are extremely pleased to have had the opportunity to participate in this study. Reolysin is very well tolerated and a number of patients have derived clinical benefit. Based on the study results, which will be updated and presented in 2009, further studies are planned in patients with sarcoma."
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