GAITHERSBURG, Md., Nov. 15 /PRNewswire-FirstCall/ -- MedImmune, Inc.
(Nasdaq: MEDI) today announced that it has initiated a Phase 3 study to
evaluate the safety and efficacy of Numax in reducing respiratory syncytial
virus (RSV) disease in healthy full-term Native American (Navajo and White
Mountain Apache) infants. Recently accumulated epidemiological data indicate
that the risks associated with RSV disease for otherwise healthy, full-term
Native American infants is similar to those commonly associated with children
considered to be at high-risk to the virus, including children born
prematurely or with chronic lung disease or congenital heart disease. In
addition to the risk from RSV itself, Native American children have a high
rate of wheezing and asthma.
"By conducting this Phase 3 study, we hope to determine if Numax can play
a role in reducing the burden of RSV disease among these Native American
infants," said Edward M. Connor, executive vice president and chief medical
officer. "Moreover, we will monitor the children enrolled in this study until
they reach five years of age, and collect valuable data on whether reducing
RSV disease with Numax in the first two years of life can reduce the incidence
of wheezing and prevent the development of asthma in full-term healthy
The Native American Phase 3 study of Numax is a randomized, double-blind,
placebo-controlled trial that will enroll approximately 3,000 Navajo and White
Mountain Apache infants over four RSV seasons. All children in the study will
receive a maximum of five monthly intramuscular injections of Numax (15 mg/kg)
or placebo during the RSV season for two consecutive seasons. During the first
year, plans are to enroll approximately 450 infants and assess the study's
overall operational feasibility.
In addition to the Native American trial, MedImmune also recently
announced that it had initiated a Phase 3 study comparing the safety and
efficacy of Numax in reducing RSV disease in high-risk infants to that of
Synagis(R) (palivizumab), the current standard of care for reducing RSV
hospitalizations in this population. 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
comparative 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.
About RSV and Synagis
RSV is the most common respiratory infection in infancy or childhood,
resulting in over 125,000 hospitalizations in the U.S. annually in children
less than one year of age. Approximately one-half of all infants are infected
with RSV during the first year of life, and nearly all children have been
infected at least once by the time they reach their second birthday. 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
Synagis is marketed 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 from October through May. Synagis is
a humanized monoclonal antibody given through a simple intramuscular injection
once a month during the RSV season. Synagis was initially licensed by the FDA
in 1998 to prevent RSV hospitalizations in high risk infants, and in 2003, its
label was expanded to include safety and efficacy data supporting its use in
young children with hemodynamically significant congenital heart disease to
prevent hospitalization caused by RSV. For full prescribing information for
Synagis, see the company's website at http://www.medimmune.com.
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 approximately 1,900 employees
worldwide, MedImmune is headquartered in Maryland. For more information, visit
the company's website at http://www.medimmune.com.
This announcement may contain, in addition to historical information,
certain forward-looking statements that involve risks and uncertainties. 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. The company is developing several products for potential
future marketing. 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 were received, such products would
ultimately achieve commercial success.
SOURCE MedImmune, Inc.
/CONTACT: Media: Jamie Lacey, +1-301-398-4035, or Investors: John Filler,
+1-301-398-4086, both of MedImmune, Inc./
/Web site: http://www.medimmune.com/
CO: MedImmune, Inc.
IN: MTC HEA BIO
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