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Phase 2 Trial Explores the Effect of AVR118 on Weight, Appetite, Performance Status
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.
"We are delighted to have our first two patients enrolled in the clinical trial," said Dr. Elma S. Hawkins, President and CEO of Advanced Viral Research Corp. "We continue to bring additional clinical sites on board in order to ensure a rapid completion of patient recruitment in this trial."
The Phase II, multi-center, randomized, double-blind study is designed to evaluate the effect of a 4.0 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 in order 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.
ADVR's AVR118 represents a biopolymer that possesses novel immunomodulatory activity. This peptide-nucleic acid complex, which to date has demonstrated a very favorable safety profile, appears to stimulate the proinflammatory responses required to combat viral infections such as AIDS and human papillomavirus, and to dampen aberrant autoimmune-type inflammatory responses, such as those which occur in patients with rheumatoid arthritis.
The Phase I/II clinical trial of AVR118 in AIDS patients, which was conducted in Israel, concluded that AVR118 continues to demonstrate evidence of unique patient benefits, a favorable safety profile, and no apparent drug-related adverse events. Unique patient benefits included weight gain, mood improvement, decrease in fatigue, and increase in ability to perform everyday tasks.
Source: Advanced Viral Research Corp.