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www.fdanews.com/articles/69985-advanced-viral-initiates-a-phase-ii-trial-in-the-u-s-for-avr118

Advanced Viral Initiates a Phase II Trial in the U.S. for AVR118

March 18, 2005

Advanced Viral Research has initiated a Phase II, multicenter clinical trial in the U.S. for AVR118.

The study will examine the safety, tolerability and efficacy of AVR118 in patients with advanced cancer who are suffering from symptoms of progressive disease. Advanced Viral Research is collaborating with The Biomedical Research Alliance of New York for this Phase II trial and is currently actively recruiting patients.

The study is designed to evaluate the effect of a 4-mL dose of AVR118 administered to patients with systemic symptoms related to advanced cancers who are not candidates for, or who do not wish to receive, chemotherapy. Patients will be on the drug for three weeks to compare treatment versus no treatment, after which the results of the study will be analyzed. Those who did not receive AVR118 during the first three weeks will be permitted to take the drug for three weeks.

Patients who appear to benefit from treatment may be eligible to remain on AVR118, generating longer term safety data. Approximately 40 adult patients with advanced cancer are expected to be entered into the study. Eligible patients will be between the ages of 18 and 80, will have a Karnofsky performance score between 40 and 80, and a life expectancy of more than four months.