Business Wire - December 27, 2004
"ADVR has achieved a major milestone in the development of AVR118," said Dr. Elma Hawkins, President and CEO of Advanced Viral Research Corp. "We are very excited to be advancing this important drug into Phase II clinical trials in the U.S."
After review of ADVR's IND which was submitted at the end of November 2004, the FDA notified the Company that it may proceed with its Phase II, multi-center clinical trial 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. Successful completion of this trial will then provide the platform to conduct further studies in patients with other complications of cancer.
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 HIV 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's (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 or Kelly Cinelli, 508-222-4802
SOURCE: Advanced Viral Research Corp.
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