Avanced Viral Research Corp. Initiates a Phase I, Safety Study for AVR118 in Type 2 Diabetic Subjects
Monday October 3, 7:03 am ET
YONKERS, N.Y.--(BUSINESS WIRE)--Oct. 3, 2005--Advanced Viral Research Corp. (OTC Bulletin Board: ADVR - News) 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.
biz.yahoo.com
|
