Novavax Inc. (NVAX-NASDAQ) is up 8.5% in pre-market stock trading on positive data coming out of its pandemic flu studies. This is not being studied on humans, as ferrets are the inoculation group. Ferrets were inoculated with the company’s virus-like particle vaccine made from an Indonesian strain of H5N1 avian influenza.
Ferrets are supposed to represent the most relevant influenza animal model for humans, and they were then challenged with live H5N1 virus. All ferrets that received the Novavax vaccine survived, even those that received the lowest dose. According to the Novavax, the ferrets that received Novavax’s H5N1 vaccine were protected not only against the Indonesian strain of avian flu but also were cross-protected against a separate strain originating in Vietnam; and all ferrets that received the Novavax vaccine survived. The company says it is on target to file its first vaccine investigational new drug application by mid-year and it remains enthusiastic for a new vaccine candidate to take into clinic trials.
As a reminder, animals are almost always used before humans in determining safety and efficacy and this represents just the first of many hurdles for the company. Many scientists discount results in many animal studies, so this should still be considered an outstanding issue until they begin human trials and we start seeing some data. With shares up 8.5% at $3.40, that is still toward the lower-end of the 52-week trading range ($2.56 to $6.48).
Jon C. Ogg
May 3, 2007
Jon Ogg can be reached at email@example.com; he does not own securities in the companies he covers.