ROCKVILLE, Md., Dec. 16, 2010 /PRNewswire-FirstCall/ -- Novavax, Inc. (Nasdaq: NVAX) announced today that the company's Phase I clinical trial to evaluate a new vaccine candidate to prevent respiratory syncytial virus (RSV) infection has been cleared by the U.S. Food and Drug Administration (FDA) and is no longer on clinical hold. In November, the company reported that it had received a question from the FDA regarding chemistry, manufacturing and controls (CMC) that has now been resolved.
Preclinical studies of Novavax's vaccine candidate to prevent RSV infection were conducted in cotton rats, a well-accepted animal model of RSV infection and disease. Results showed induction of neutralizing antibodies and protection from RSV challenge with no disease enhancement. After the RSV challenge, no detection of disease was observed in any of the animals immunized with the vaccine candidate at any dose level tested. Novavax's vaccine uses highly purified recombinant particles of RSV-F fusion protein normally found in the virus. There is currently no approved vaccine to prevent RSV infection.
"We are excited to advance our vaccine candidate for RSV into clinical testing," said Dr. Rahul Singhvi, President and CEO of Novavax. "This is a significant accomplishment and represents the second major internally discovered vaccine program based on our core platform technologies. RSV is the leading cause of viral death in infants and a common illness in elderly adults. A safe and effective vaccine is especially needed in these populations since RSV infection does not provoke lasting immunity."
About Respiratory Syncytial Virus
RSV is the most commonly identified cause of lower respiratory tract illnesses in infants and young children worldwide. Repeated infections occur throughout life causing moderate to severe cold-like symptoms. More severe lower respiratory tract disease is also seen in elderly adults over age 65 years, similar to the severe illness witnessed in children. It is estimated that RSV infects more than 8.5 million adults annually, including the elderly over age 65 years. This virus is responsible for approximately 900,000 hospitalizations annually in the United States and major European countries. In the United States alone, RSV leads to more than 175,500 hospitalizations annually in high-risk adults resulting in annual medicals costs exceeding $1 billion.
Novavax, Inc. is a clinical-stage biopharmaceutical company creating novel vaccines to address a broad range of infectious diseases worldwide, using advanced proprietary virus-like-particle (VLP) technology. The company produces potent VLP-based recombinant vaccines utilizing new and efficient manufacturing approaches. Novavax is committed to using its VLP technology to create country-specific vaccine solutions. The company has formed a joint venture with Cadila Pharmaceuticals, named CPL Biologicals, to develop and manufacture vaccines, biological therapeutics and diagnostics in India. Additional information about Novavax is available on the company's website: www.novavax.com.