Medimmune announces phase 2 safety data for anti-RSV antibody

MedImmune, Inc. has announced results from two important studies presented at the 2007 Infectious Diseases Society of America (IDSA) 45th Annual Meeting adding to the body of knowledge about respiratory syncytial virus (RSV).

RSV is a viral pathogen that produces annual outbreaks usually between fall and spring. While RSV typically manifests cold-like symptoms in healthy children, it can prove to be a very serious respiratory illness for premature infants and is the leading cause of respiratory infections for newborns each year. MedImmune has long been committed to developing and improving products for prevention of RSV disease and to enhancing the body of knowledge about RSV epidemiology.

“MedImmune continues to forge ahead with its aggressive strategy to help combat RSV disease,” said Edward M. Connor, M.D., executive vice president and chief medical officer. “We are pleased to present new Phase 2 data at IDSA regarding motavizumab, a key investigational monoclonal antibody (MAb) within our product development portfolio that we are currently preparing for regulatory submission in the United States.”

Connor added, “We will also present data regarding RSV surveillance at IDSA. These data show regional variability of RSV in the community, particularly in the southernmost United States. We believe that a better understanding of the regional variation in the timing of RSV may help inform decisions about timing of RSV prophylaxis for children at risk for serious RSV disease.”

Data pertaining to MedImmune's anti-RSV initiatives that will be presented during the IDSA meeting include:

• Safety, Tolerability, and Immunogenicity of Motavizumab in Young Children After a Second Season of RSV Prophylaxis (Poster Presentation #233) – Katia G. Abarca, M.D., Infectious Diseases and Molecular Virology Laboratory, Universidad Católica de Chile, Friday, October 5, 2007; 12:30 – 2:00 p.m. in Poster Halls G-H.

  This study assessed the safety and immunogenicity of motavizumab, an investigational anti-RSV MAb, in young children with a history of prematurity who received two sequential seasons of the antibody.

• RSV Surveillance: Retrospective and Current Data on the Variance in Season Onsets and Offsets (Poster Presentation #719) – Jessie R. Groothuis M.D., MedImmune, Saturday, October 6, 2007; 12:15 – 1:45 p.m. in Poster Halls G-H.

  A nationwide active surveillance program was established to evaluate the variability of the RSV season temporally and geographically in the United States. Laboratory results from a three-year period were analyzed by month and by geographic region.