ADVR Receives FDA Approval of Its IND for AVR118.YONKERS, N.Y. -- Advanced Viral Research Corp. (OTC Bulletin Board OTC Bulletin Board An electronic quotation listing of the bid and asked prices of OTC stocks that do not meet the requirements to be listed on the NASDAQ stock-listing system. : ADVR ADVR Association of Directors of Volunteer Resources (Canada) ) announced today that the Company has received approval from the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) for its Investigational New Drug (IND) application for the systemic use of AVR118 in patients with advanced malignancies. "ADVR has achieved a major milestone in the development of AVR118," said Dr. Elma Hawkins, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. 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 bi·o·pol·y·mer n. A macromolecule, such as a protein or nucleic acid, that is formed in a living organism. biopolymer any protein or nucleic acid produced by a living organism. 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 HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. 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 loss of appetite Medtalk Anorexia, see there , 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 Yonkers is the fourth largest city in the State of New York (it falls behind New York City, Buffalo, and Rochester), and the largest city in Westchester County, with a population of 196,086 (according to the 2000 census). , 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. |
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