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Press Release Source: MedImmune, Inc.
MedImmune Initiates Pivotal Phase 3 Study for Numax(TM) to Prevent Respiratory Syncytial Virus in High-Risk Infants
Monday November 1, 11:28 am ET
GAITHERSBURG, Md., Nov. 1 /PRNewswire-FirstCall/ -- MedImmune, Inc. (Nasdaq: MEDI - News) today announced that it has initiated a pivotal Phase 3 study for Numax to evaluate the monoclonal antibody's potential to prevent serious respiratory syncytial virus (RSV) in high-risk infants. The study will compare the safety and efficacy of Numax to Synagis® (palivizumab), the current standard of care for reducing RSV hospitalizations in this population, when administered monthly by intramuscular injection.
In preclinical studies, Numax has been shown to be more potent than Synagis in reducing RSV replication in both the lower and upper respiratory tract when given at the same dose. The Numax Phase 3 trial is designed to assess if the increased potency seen in preclinical studies can be translated into better efficacy against lower respiratory tract illness in high-risk children and to assess the effect of Numax on upper respiratory tract disease, such as otitis media.
"The development of Numax is another example of MedImmune's ongoing commitment to advancing new medicines designed to prevent serious illness in children," said Edward M. Connor, M.D., executive vice president and chief medical officer. "We are making significant investments in research and development to produce antibodies and vaccines to prevent several important respiratory diseases that can severely impact the lives of infants and children."
The Numax Phase 3 study is a randomized, double-blind, multi-center, multi-national trial. It will be conducted during two Northern Hemisphere RSV seasons and will include approximately 5,750 children. The study group will consist of premature infants born at 35 weeks gestational age or less who are six months of age or younger at enrollment, and children with chronic lung disease, who are 24 months of age or less at enrollment. |
