MedImmune completes enrollment in Numax trials for respiratory syncytial virus infections

By Angela McDaniels

Seattle, Dec. 15 - MedImmune Inc. said it has completed enrollment of roughly 6,600 high-risk infants in a phase 3 study comparing the safety and efficacy of Numax to Synagis (palivizumab).

MedImmune also completed enrollment of more than 620 patients in a separate, late-stage clinical study with Numax in children with hemodynamically significant congenital heart disease.

MedImmune is developing Numax as a potential improvement to Synagis, which was introduced to the market in 1998 and has become the standard of care for the prevention of serious respiratory syncytial virus disease in these infants, the company said.

"To date, Synagis has been used to protect more than 700,000 infants in the United States from respiratory syncytial virus. If the phase 3 program is successful and Numax is approved, we may be able to provide enhanced respiratory syncytial virus prophylaxis for infants at risk for serious respiratory syncytial virus disease," said Genevieve Losonsky, vice president of clinical development for infectious disease, in a company news release.

The 2005 impact of incremental recruiting and enrollment costs for both trials is anticipated to be about $10 million, which was not included in MedImmune's financial guidance for 2005, issued on Oct. 20.

Numax versus Synagis phase 3 study

The phase 3 study is designed to compare the safety and efficacy of Numax with that of Synagis for reduction of respiratory syncytial virus hospitalization in high-risk infants. Secondary endpoints include medically attended lower respiratory tract infections and ear infections.

The randomized, double-blind trial is being held at 300 centers in 24 countries.

Study participants are premature infants born at 35 weeks gestational age or less who were six months of age or younger at randomization, as well as children with chronic lung disease related to prematurity, who were 24 months of age or less at randomization.

Each child receives an intramuscular injection of 15 mg/kg of Numax or Synagis each month during the respiratory syncytial virus season for a total of five injections, the company said.

Participants will be monitored throughout the trial for safety, lower-respiratory-tract infections, ear infections and hospitalizations.

Numax and congenital heart disease study

This randomized, double-blind, Synagis-controlled study will evaluate the safety, tolerability, immunogenicity and pharmacokinetics of Numax. It is being conducted at about 160 sites during the 2005-2006 respiratory syncytial virus season.

Study participants include infants with hemodynamically significant congenital heart disease who were 24 months of age or younger at randomization.

Roughly 620 patients will receive an intramuscular injection of either 15 mg/kg of Numax or Synagis each month for five months. Children will be followed throughout the study for safety.

Blood samples will be collected for assessment of immunogenicity and pharmacokinetics, the company said, and hospitalizations due to respiratory syncytial virus will be assessed as a secondary endpoint.

Respiratory syncytial virus is the most common respiratory infection in infancy or childhood. Children born prematurely as well as those with chronic lung disease or congenital heart disease are at highest risk of severe disease and hospitalization due to respiratory syncytial virus, the company said.

Numax is an investigational humanized monoclonal antibody. Phase 1 and phase 2 studies show that Numax appears to have a similar safety and pharmacokinetic profile to Synagis in infants. Additionally, in early phase studies children treated with Numax had reduced respiratory syncytial virus replication in the upper respiratory tract, the company said.

Synagis is indicated for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus in pediatric patients at high-risk of the disease. Synagis is a humanized monoclonal antibody given by an intramuscular injection once a month.

MedImmune is a pharmaceutical company based in Gaithursburg, Md., that develops products to treat infectious diseases, cancer and inflammatory diseases.

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