Advanced Viral Research Enrolls First Two Patients in Trial for AVR118
Advanced Viral Research has announced that the first two patients have been enrolled in its Phase II, multicenter clinical trial of AVR118 in the U.S.
The study will examine the safety, tolerability and efficacy of AVR118 in patients with advanced cancer who are suffering from symptoms of progressive disease, including weight loss, fatigue and loss of appetite. The primary objective of the study is to explore the effect of AVR118 on weight, appetite, performance status and other measures of quality of life related to advanced malignancies as compared to patients not receiving AVR118.
The trial is being coordinated through the BRANY network of hospitals. The current clinical sites participating in the trial are North Shore University Hospital in New York and the Medical Center of Vincennes in Indiana. Additional sites will follow in the very near future.
The Phase II, multicenter, randomized, double-blind 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. The Karnofsky Performance score is a validated measure of a patient's ability to perform tasks of every day living.