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MedImmune Begins Dosing in Phase 1 Clinical Trial for Nasally Delivered Vaccine Designed to Help Prevent Common Childhood Respiratory Viral Diseases

Posted on: Friday, 15 April 2005, 09:00 CDT

GAITHERSBURG, Md., April 15 /PRNewswire-FirstCall/ -- MedImmune, Inc. announced today that is has begun dosing adult volunteers in a Phase 1 clinical trial with its respiratory syncytial virus (RSV) vaccine candidate. The vaccine was developed using an attenuated parainfluenza virus type-3 (PIV-3), which was previously evaluated in a Phase 1 clinical trial in infants and recently modified to induce immunity to RSV. Data from preclinical studies indicate that the vaccine protects against both RSV and PIV-3.

"Our vaccine candidate is unique because it leverages MedImmune's novel intranasal technology to target RSV, and possibly PIV-3, through a single intranasal immunization," said Edward M. Connor, M.D., chief medical officer. "If successfully developed and approved, this vaccine may offer pediatricians an intranasal option to protect children broadly against respiratory disease caused by two important respiratory pathogens. These pathogens are responsible for significant illnesses in children and significant healthcare expenditures annually."

The Phase 1 clinical study is designed to evaluate the vaccine's safety, tolerability, and immunogenicity. It is a randomized, double-blind, placebo- controlled, dose-escalation study in approximately 120 healthy men and women between the ages of 18 and 40 years. MedImmune filed an investigational new drug application with the U.S. Food and Drug Administration (FDA) for the vaccine candidate in January 2005.

The combination vaccine is expected to offer ease of administration for pediatricians and their patients, and may help reduce RSV/PIV-3-associated illnesses and hospital costs in the United States. RSV and PIV-3 are viruses that cause serious respiratory disease. RSV is the most common cause of lower respiratory tract infections in infants and children worldwide, typically occurring during the fall and winter months. There are approximately 125,000 RSV-associated hospitalizations each year in the United States. Lower respiratory tract disease due to PIV-3 is responsible for as many as 50,000 hospitalizations annually in the United States with approximately half of those in infants less than one year old.

The advancement of MedImmune's vaccine candidate into a Phase 1 clinical study underscores the company's efforts to leverage the latest vaccine technologies with its proven experience in developing options for the prevention of respiratory infectious disease. MedImmune products have helped to protect children from RSV since 1996. Now the standard of care for the prevention of RSV in high-risk infants, Synagis(R) (pavilizumab) was the first monoclonal antibody approved by the FDA to combat an infectious disease. To date, Synagis has helped protect more than 700,000 premature and/or high-risk infants against RSV disease. MedImmune is also the developer and manufacturer of FluMist(R) (Influenza Virus Vaccine Live, Intranasal), the first FDA- approved intranasal influenza vaccine in the United States.

About Synagis

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. The adverse reactions most commonly observed in Synagis-treated patients were upper respiratory tract infection, ear infection, fever, runny nose, rash, diarrhea, cough, vomiting, gastroenteritis and wheezing. Very rare cases of severe allergic reactions such as anaphylaxis (less than one case per 100,000 patients) and 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/.

About FluMist

FluMist was approved by the FDA in June 2003. It is the first live, attenuated influenza vaccine in the U.S. that is indicated for active immunization for the prevention of disease caused by influenza A and B viruses in healthy children and adolescents, 5 to 17 years of age, and healthy adults, 18 to 49 years of age. There are risks associated with all vaccines including FluMist. Like any vaccine, FluMist does not protect 100 percent of individuals vaccinated. In placebo-controlled clinical trials, the most common solicited adverse events in the indicated population of 2,762 included runny nose/nasal congestion, headache, cough, sore throat, tiredness/weakness, irritability, decreased activity and muscle aches. For full prescribing information for FluMist, 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 2,000 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. 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 a product will receive required regulatory clearance or that, even if such regulatory clearance is received, such a product will ultimately achieve commercial success.

MedImmune, Inc.

CONTACT: Media: Jamie Lacey, +1-301-398-4035, or Clarencia Stephen,+1-301-398-4073, or Investors: Peter Vozzo, +1-301-398-4358, or John Filler,+1-301-398-4086, all of MedImmune, Inc.

Web site: http://www.medimmune.com/

Source: PRNewswire-FirstCall

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