ADVR Announces Successful Pre-IND Meeting with FDA Business Wire
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ADVR Announces Successful Pre-IND Meeting with FDA

Business Wire - September 9, 2004


YONKERS, NY-- Advanced Viral Research Corp. announced today that the Company had a successful pre-IND (Investigational New Drug) meeting with the FDA at the end of August. Based on the results of the meeting, Advanced Viral Research Corp. believes it is well positioned to submit an IND application for the injectable use of AVR118 in patients with cancer by the end of 2004/beginning of 2005.

"We were delighted with the outcome of the pre-IND meeting with the Agency," said Dr. Elma Hawkins, President and CEO of Advanced Viral Research Corp. "We are building on all of the previously acquired clinical and non-clinical data as we move AVR118 through the drug approval process. Our strategy of pursuing oncology as our first therapeutic area affords us many advantages, both currently and in the future."

ADVR's AVR118 is a biopolymer that possesses novel immunomodulator activity. This peptide-nucleic acid complex, which to date has demonstrated a very favorable safety profile, appears to stimulate the pro-inflammatory responses required to combat viral infections such as AIDS and human papillomavirus and to dampen aberrant autoimmune-type inflammatory responses, such as occur in patients with rheumatoid arthritis. Data presented at the American Society of Clinical Oncology (ASCO) annual meeting in June, 2004, showed that AVR118 appears to have activity against fatigue, loss of appetite, and weight loss in patients with HIV.

For further information regarding Advanced Viral Research Corp., please visit our website at www.adviral.com. ADVR, 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.

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.

CONTACT: CWR & Partners, LLP

Ronnie Welch, 508-222-4802, Ronnie@cwrpartners.com

SOURCE: Advanced Viral Research Corp.


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