ROCKVILLE, MD. July 9, 2007. MacroGenics announced today that the companys 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.
About West Nile Virus
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.
About MacroGenics, Inc.
Founded in 2000, MacroGenics is a private, venture-backed biotechnology company headquartered in Rockville, Maryland that focuses on the development, manufacture, and commercialization of immunotherapeutics for autoimmune disorders, cancer and infectious diseases. The companys proprietary Fc engineering technology offers ways of improving antibody function, such as enhancing the antibodys ability to eliminate cancer cells, cells that contribute to autoimmune disorders, or those infected with certain pathogens. The company is developing first-in-class product candidates from its autoimmunity, oncology and infectious disease portfolios. For more information about MacroGenics, please visit www.macrogenics.com.
Statements made in this news release that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "expects", "believes", "intends", and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as the Companys ability to raise additional capital, and risks related to the Companys ability to initiate, and enroll patients in, planned clinical trials. You should not place undue reliance on any forward-looking statements. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by law.
Dr, Kathryn Stein