Advanced Viral Research Corp. To Initiate Phase I Trial of Product R FDA Accepts IND for Trials Related to Topical Treatment for Genital Warts.

Business Editors

YONKERS, N.Y.--(BUSINESS WIRE)--Sept. 4, 2001

Advanced Viral Research Corp. (OTCBB:ADVR) today announced that the United States Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for Phase I clinical trials of Product R as a topical treatment for genital warts.

Nearly one million new cases of genital warts are diagnosed annually in the United States according to the Centers for Disease Control and Prevention (CDC); new effective, non-toxic and well-tolerated therapies are needed.

The Phase I trial, which will be conducted under the guidance of FDA consultants Globomax LLC, will evaluate the safety of topically applied Product R in humans. Upon successful completion of the Phase I studies, the Company plans to initiate Phase II trials to test the efficacy and dosage of Product R in the topical therapy of genital warts. The IND was filed with the FDA on July 30, 2001.

"The acceptance of our IND for Product R is a testament to the quality of the biopharmaceutical research being conducted by our scientific teams. It is a significant milestone in our ongoing development of Product R. With the acceptance of our IND, we are closer to bringing the potential benefits of our research on Product R to patients afflicted by the human papilloma virus (HPV), the cause of genital warts," said Shalom Z. Hirschman, MD, President and CEO of ADVR. "We are moving to place Product R into the hands of awaiting patients as quickly as possible."

Product R is a non-toxic peptide nucleic acid-type immunomodulator that appears to stimulate the proinflammatory responses required to combat viral infections such as AIDS and human papilloma virus and to dampen aberrant autoimmune-type inflammatory responses, such as occur in patients with rheumatoid arthritis. Therefore, Product R has been termed a "switch type" immunomodulator. Product R has direct antiviral effects against select viruses such as adenovirus and human papilloma virus. Product R has shown promise in its ability to mitigate the toxic side effects of other drugs, including those used to treat HIV infection and chemotherapeutic drugs employed in the treatment of cancers.

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 ADVR. 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 ADVR will be able to secure the financing necessary to complete the clinical trials of Product R. ADVR 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.