GAITHERSBURG, Md., Jan. 20 /PRNewswire-FirstCall/ -- MedImmune, Inc.
(Nasdaq: MEDI) announced today that is has filed an investigational new drug
application (IND) to begin clinical studies of its respiratory syncytial virus
(RSV) and parainfluenza virus type-3 (PIV-3) candidate vaccine. Data from
preclinical studies indicate that the combination vaccine elicited protective
immune responses to RSV and PIV-3, two leading causes of pediatric respiratory
Upon the U.S. Food and Drug Administration's review and approval of the
IND, MedImmune plans to initiate a Phase 1 clinical study for the RSV/PIV-3
candidate vaccine. The study will evaluate the safety, tolerability and
immunogenicity of the vaccine in healthy adults who have had multiple years of
exposure to wild type RSV and PIV-3.
RSV and PIV-3 are viruses that cause serious respiratory disease,
particularly in young children, the elderly and immunocompromised individuals.
RSV is the most common cause of lower respiratory tract infections in infants
and children worldwide, typically occurring during the fall and winter months.
PIV-3 is the leading cause of croup, an acute lower respiratory disease most
often observed in young children.
The RSV/PIV-3 candidate vaccine will leverage MedImmune's novel intranasal
vaccine technology. Upon approval, the vaccine would have the potential to
provide a new, needle-free option to help protect against two respiratory
diseases that are responsible for significant healthcare expenditures
"We believe that a vaccine engineered to target both the RSV and PIV-3
viruses will significantly reduce respiratory disease burden in children,"
said Richard Spaete, Ph.D., senior research director at MedImmune. "With more
than 125,000 children hospitalized with RSV-related complications each year
and thousands of children impacted by croup, the development of a safe and
effective vaccine will be a significant public health milestone."
Preclinical studies have shown that a combination of the bovine and human
versions of PIV-3 used as the vector in this new approach could be
successfully constructed as a carrier to induce a protective immune response
against PIV-3 and RSV.
Preliminary data from one such preclinical study of RSV/PIV-3 were
published in the October 2004 issue of Journal of Virology. Results of this
study, entitled "Parainfluenza Virus Type-3 Expressing the Native or Soluble
Fusion (F) Protein of Respiratory Syncytial Virus (RSV) Confers Protection
from RSV Infection in African Green Monkeys," helped fuel MedImmune's efforts
to develop a novel RSV/PIV-3 vaccine.
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 contains, in addition to historical information, certain
forward-looking statements that involve risks and uncertainties, in
particular, related to the research and development of a potential RSV/PIV-3
combination vaccine product and a potential PIV-3/hMPV combination vaccine
product. 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.
CONTACT: Media: Jamie Lacey +1-301-398-4035or Investors: Peter Vozzo
+1-301-398-4358 or John Filler +1-301-398-4086all of MedImmune, Inc.
Web site: http://www.medimmune.com