Message #4 From:
NewsBot Date: October 3, 2005 12:03:00 AM
ADVR News Advanced Viral Research Corp. Initiates a Phase I, Safety Study for AVR118 in Type 2 Diabetic Subjects
YONKERS, N.Y.--(BUSINESS WIRE)--Oct. 3, 2005--Advanced Viral Research Corp. (OTC Bulletin Board: ADVR) announced today that it has initiated a Phase I, Double Blind, Placebo Controlled, Randomized, Single Center, Safety Study with AVR118 in Type 2 Diabetic Subjects in the U.S. Approximately 30 patients are expected to be entered in the study.
The primary objective of this study is to explore the effect of 4.0 ml AVR118 given subcutaneously on blood glucose in subjects with type 2 diabetes who are on sulfonylureas and/or metformin, as compared to subjects not receiving AVR118. Sulfonylureas and metformin are commonly used drugs to control type 2 diabetes.
Additional objectives of this study are to explore the mechanism of action of AVR118 in potentially decreasing blood glucose in patients with type 2 diabetes and to explore the effect, if any, of AVR118 on other blood parameters associated with type 2 diabetes.
Currently, patients with diabetes are excluded from ADVR's studies. This Phase 1 study is designed to demonstrate whether there is any effect of AVR118 on glucose levels of patients with type 2 diabetes.
"This safety study is an important step toward regulatory approval for AVR118 and could lead us to other patient populations," said Dr. Elma S. Hawkins, President and CEO of Advanced Viral Research Corp.
Currently, ADVR is also engaged in a Phase II, multi-center, randomized, double-blind United States study 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.
ADVR's AVR118 represents 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 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.
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.
