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NewsBot Date: July 13, 2005 06:19:00 AM
ADVR News Advanced Viral Research Corp. Adds 4th Site for its Phase II Clinical Trial for AVR118
YONKERS, N.Y.--(BUSINESS WIRE)--July 13, 2005--Advanced Viral Research Corp. (OTC Bulletin Board: ADVR) announced today the addition of Queens Medical Associates in New York as a new clinical site for its Phase II, multi-center clinical trial of AVR118 in the U.S. Other participating sites include North Shore University Hospital of New York and Jacobi Medical Center, both in New York, and the Medical Center of Vincennes in Indiana.
The study is examining 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 Biomedical Research Alliance of New York (BRANY) network of hospitals.
"We are delighted to be adding Queens Medical Associates to our trial," said Dr. Elma S. Hawkins, President and CEO of Advanced Viral Research Corp. "We continue to accrue patients, and we are pleased with the progress of the study."
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 everyday 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.
Advanced Viral Research Corp., based in Yonkers, New York, is a biopharmaceutical firm dedicated to improving patients' lives by researching, developing and bringing to market new and effective therapies for viral and other diseases. For further information regarding Advanced Viral Research Corp., please visit our website at www.adviral.com.
Note: This news release contains forward-looking statements that involve risks associated with clinical development, regulatory approvals, including application to the FDA, product commercialization and other risks described from time to time in the SEC reports filed by the Company. AVR118 (Product R) is not approved by the U.S. Food and Drug Administration or any comparable agencies of any other countries. There is no assurance that the Company will be able to secure the financing necessary to continue and/or complete the clinical trials of AVR118 or satisfy certain other conditions relating to clinical trials including obtaining adequate insurance on terms acceptable to the Company or that if completed, clinical trials performed outside the United States will assist the Company in obtaining FDA or other regulatory approval. The Company undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.
Press Release Information Source: Advanced Viral Research
