MacroGenics investigational new drug for West Nile vrus monoclonal antibody is active

MacroGenics has announced that the company's investigational new drug (IND) application to the U.S. Food and Drug Administration for its monoclonal antibody targeted to West Nile Virus is now active.

MGAWN1 is a humanized monoclonal antibody that specifically neutralizes the virus.

"We are delighted with this recent news from the FDA and very much looking forward to starting a Phase 1 clinical trial in healthy volunteers this year," stated Dr. Scott Koenig, President and CEO of MacroGenics. "Currently, there are no approved treatments for individuals with severe West Nile Virus infection. These patients are hospitalized and provided supportive care. Therefore, a therapy that neutralizes the virus and could possibly reduce or prevent these complications would represent a significant advancement for these patients."

In September 2006, MacroGenics was awarded a $50 million contract from the National Institute for Allergy and Infectious Diseases to support the development of MGAWN1 through manufacturing and Phase 2 clinical trials. If approved for marketing by the U.S. Food and Drug Administration, the antibody could be used for the treatment of individuals with confirmed diagnoses of West Nile Virus infection or individuals who have signs and symptoms consistent with West Nile Virus neuroinvasive disease.

West Nile Virus causes seasonal epidemics of febrile illness and severe neurological disease and is currently the most common cause of arboviral encephalitis in the United States. In 2006, the Centers for Disease Control and Prevention (CDC) reported 4,269 cases of West Nile Virus. Since 1999, when West Nile Virus was first detected in North America, close to 24,000 cases have been reported to the CDC, nearly 10,000 of which involved neuroinvasive disease.