ROCKVILLE, Md., Jan. 12 /PRNewswire-FirstCall/ -- Novavax, Inc. announced today that it has successfully completed a pre-clinical safety and efficacy study of its RSV vaccine candidate in cotton rats. Results from this study are needed to support an Investigational New Drug (IND) application to advance this novel recombinant F protein particle based RSV (RSV-F) vaccine candidate into clinical development. This vaccine candidate is composed of recombinant ‘F’ or ‘fusion’ protein of RSV which is used by the virus to infect and fuse with cells in the respiratory tract and cause disease.
RSV vaccines require a heightened evaluation of safety because of a failed study in children in the mid-1960s with a formalin-inactivated RSV vaccine candidate that caused enhancement of the disease. In the current study, the lungs of RSV challenged cotton rats were examined and there was no sign that immunization with the Novavax RSV-F vaccine candidate resulted in enhanced disease. However, RSV-induced pathology in the lungs was observed in animals immunized with a formalin-inactivated RSV control.
In addition to completing this important preclinical study in cotton rats, Novavax today announced the successful scale up of the manufacturing process for the RSV-F vaccine candidate. Material produced with this process under current Good Manufacturing Practices (cGMP) is currently being used in a formal toxicology study in rabbits.
About Novavax
Novavax, Inc. is a clinical-stage biotechnology company creating novel vaccines to address a broad range of infectious diseases worldwide, including H1N1, 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.
(1) Datamonitor - December 2006
Novavax, Inc.
