NOVAVAX Launches Phase I Clinical Trial To Evaluate Its Novel Vaccine Against Respiratory Syncytial Virus (RSV)

Novavax, Inc. (Nasdaq: NVAX) announced that it has begun patient enrollment in a Phase I clinical trial to assess the safety, immunogenicity and tolerability of a vaccine candidate against respiratory syncytial virus (RSV). In this blinded, placebo-controlled, escalating-dose study of healthy adults 18 to 49 years old, a total of 100 subjects will be allocated to four cohorts and randomized to receive vaccine treatment or saline placebo in a 4:1 ratio. It is expected that interim top-line data from the trial will be available in the third quarter of 2011.
Remarking on this key accomplishment for the Company, Dr. Rahul Singhvi, Novavax's President and CEO, said, "The launch of this trial is timely because there are no vaccines currently approved for RSV disease, which is the most important viral cause of lower respiratory tract infection in infants and children worldwide and is a major cause of respiratory illness in elderly adults. The initiation of the trial for this RSV vaccine candidate marks a key milestone for Novavax, as the Company now has a clinical candidate in a second major disease target in addition to influenza."

Novavax has evaluated its RSV vaccine candidate in well-accepted animal models of toxicity and disease and found it to be safe at all doses tested. Preclinical results have shown induction of neutralizing antibodies and protection from RSV challenge with no disease enhancement and no detection of disease in any of the animals immunized with the vaccine at any dose level tested. Novavax's vaccine uses highly purified recombinant particles of RSV-F fusion protein normally found in the virus.

About Respiratory Syncytial Virus

RSV is the most important viral cause of lower respiratory tract infection in infants and children worldwide. The global disease burden is estimated at 64 million cases and 160,000 deaths every year. RSV is the most common cause of bronchiolitis (inflammation of the small airways in the lung) and pneumonia in children under 1 year of age in the United States. Each year, 75,000 to 125,000 children in this age group are hospitalized due to RSV infection. Almost all children will have had an RSV infection by their second birthday. When infants and children are exposed to RSV for the first time, 25% to 40% of them have signs or symptoms of bronchiolitis or pneumonia, and 0.5% to 2% will require hospitalization. Most children hospitalized for RSV infection are under 6 months of age. Additionally, wheezing illnesses caused by RSV, particularly those severe enough to lead to hospitalization, are associated with an increased risk of asthma at school age.

It is also estimated that more than 8.5 million adults, including the elderly over age 65 years, are infected and 900,000 patients are hospitalized annually due to RSV infection in the United States and major European countries. In the United States alone there are 177,500 hospitalizations among high-risk adults resulting in annual medical costs exceeding $1 billion. There is currently no approved vaccine for the prevention of RSV.

Source: Novavax, Inc

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