GAITHERSBURG, Md., June 29 /PRNewswire-FirstCall/ -- MedImmune, Inc. (Nasdaq: MEDI) announced today that it has expanded its efforts to develop live, attenuated intranasal vaccines against important viral pathogens that cause respiratory diseases. Two of these vaccine candidates will target leading causes of pediatric respiratory disease in the United States: human respiratory syncytial virus (RSV) and human parainfluenza virus type 3 (PIV- 3). To broaden its development options for potential vaccines against these and other pathogens, MedImmune has entered into a Cooperative Research and Development Agreement (CRADA) with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH). Additionally, MedImmune has started vaccinating patients in a second Phase 1 study with MEDI-534, the company's own combination RSV/PIV-3 vaccine candidate.
"MedImmune is pursuing a multi-pronged approach to finding the quickest path to developing a successful human RSV/PIV-3 vaccine," said Genevieve Losonsky, M.D., vice president, clinical development, infectious disease and vaccines. "The CRADA with the NIH allows us to combine our knowledge and resources with those of the researchers at the NIAID's Laboratory of Infectious Diseases to potentially develop new and innovative approaches against these common pediatric respiratory viruses."
Through the CRADA, MedImmune and NIAID researchers will work to develop live, attenuated intranasal vaccines designed to reduce the consequences of disease caused by RSV; PIV types 1, 2 and 3; and human metapneumovirus (hMPV). These viruses are responsible for more than half of all hospitalizations for pediatric respiratory tract disease and may cause bronchiolitis, pneumonia and/or croup.
Under the direction of Co-Chief Brian Murphy, M.D., NIAID's Laboratory of Infectious Diseases (LID) has had a long-standing interest in developing intranasal vaccines for pediatric respiratory viruses. The NIAID component of the cooperative research agreement will be led by Peter L. Collins, Ph.D., LID senior investigator. Using a reverse genetics technology developed by Dr. Collins, researchers will initially focus on developing safe and effective vaccines for pediatric populations. A secondary goal is to evaluate multiple vaccines for other groups at risk for developing RSV disease, including the elderly. NIAID is expected to initiate a Phase 1 trial of a PIV-3 vaccine candidate later this year.
MedImmune also has continued to advance the development of its first live, attenuated intranasal RSV/PIV-3 vaccine candidate, MEDI-534. The company recently began enrolling healthy RSV- and PIV-3 sero-positive children between 1 and 9 years of age in a Phase 1 study. This trial is a double-blind, placebo-controlled, dose-escalation study designed to evaluate the safety and tolerability of a single dose of the vaccine candidate. Children in the study will be randomized one-to-one to receive MEDI-534 or placebo. In MedImmune's previous clinical trial with MEDI-534, the vaccine candidate was evaluated in healthy adults and found to have an acceptable safety profile.
RSV is a common respiratory infection that affects approximately one-half of all infants during the first year of life. Nearly all children in the U.S. are infected with RSV by age 2. The virus may also cause severe illness in other groups, such as the elderly, those with underlying respiratory or cardiac disease, and those with compromised immune systems (e.g., bone marrow transplant patients). PIV-3 is another commonly occurring respiratory virus of childhood, causing bronchitis, bronchiolitis, croup, cough, fever and pneumonia. These viruses may also lead to acute otitis media in children.
Currently, there are no licensed vaccines available to protect against RSV or PIV-3 in the United States. Synagis(R) (palivizumab), MedImmune's currently marketed anti-RSV antibody, was approved by the U.S. Food and Drug Administration (FDA) in 1998. To date, Synagis has helped to protect more than 700,000 high-risk infants against RSV. Whereas Synagis is indicated for prevention of RSV in high-risk infants, MedImmune's RSV vaccine candidates will likely be targeted at a broader pediatric population, including healthy full-term infants.
About Synagis
Synagis is indicated for the prevention of serious lower respiratory tract disease caused by RSV in pediatric patients at high risk of RSV disease, which is prominent in the Northern Hemisphere during the winter months. Synagis is a humanized monoclonal antibody given by an intramuscular injection once a month during the RSV season. Synagis was approved in 1998 by the FDA; in 1999, by the European Medicines Evaluation Agency; and in 2002, by the Japanese Ministry of Health, Labor and Welfare. In 2003, the FDA expanded the U.S. label for Synagis for use in young children with hemodynamically significant congenital heart disease at risk of RSV disease. To date, Synagis has been approved in 62 countries, including the United States. In clinical trials, the most common adverse events occurring at least 1 percent more frequently in Synagis-treated patients were upper respiratory infection, otitis media, fever and rhinitis. Cynanosis and arrhythmia were seen in children with CHD. Very rare cases of anaphylaxis (less than 1 case per 100,000 patients) and rare hypersensitivity reactions have been reported. Synagis should not be used in patients with a history of a severe prior reaction to Synagis or its components. For full prescribing information for Synagis, see the company's website at: http://www.medimmune.com/products/synagis/index.asp.
About MedImmune, Inc.
MedImmune strives to provide better medicines to patients, new medical options for physicians, rewarding careers to employees, and increased value to shareholders. Dedicated to advancing science and medicine to help people live better lives, the company is focused on the areas of infectious diseases, cancer and inflammatory diseases. With more than 2,300 employees worldwide, MedImmune is headquartered in Maryland. For more information, visit the company's website at http://www.medimmune.com.
This announcement contains, in addition to historical information, certain forward-looking statements that involve risks and uncertainties, in particular, related to the research and development of potential vaccines targeting pediatric respiratory diseases. Such statements reflect management's current views and are based on certain assumptions. Actual results could differ materially from those currently anticipated as a result of a number of factors, including risks and uncertainties discussed in MedImmune's filings with the U.S. Securities and Exchange Commission. There can be no assurance that such development efforts will succeed, that such products will receive required regulatory clearance or that, even if such regulatory clearance is received, such products will ultimately achieve commercial success.
SOURCE MedImmune, Inc.