Clinical Trial Results for H1N1 Vaccine Expected Soon (NASDAQ:NVAX)

On December 2, 2009 Novavax, Inc. (NASDAQ:NVAX) announced that it has received encouraging primary data from the first stage of the Phase 2 trial. The trial is being carried out on the company’s newly developed vaccine that is intended to be used to get immunogenicity from H1N1 virus like particle (VLP) pandemic influenza, which is more commonly known as “swine flu”. This trial measures the effectiveness (more specifically, how immune the users become to the H1N1 virus) and the safety of using the vaccine. The Phase 2 trial is comprised of two stages, and the company has just completed the first one. The first stage had 1000 participants. These participants were aged between 18 and 64 years. These participants were completely healthy, and had not previously contracted the H1N1 virus. The complete results of the trial on these 1000 participants would be available by January 31, 2010.

The trial was conducted in Mexico. It was not easy for Novavax Inc to conduct the trial alone in that country. In addition, if it had conducted the trial alone, it would have faced increased difficulty to get the vaccine registered in Mexico. As a result, the company decided to form a collaboration with Avimex Laboratories, which is based in Mexico. Under the collaboration agreement, both countries would conduct all stages of the trial together and would assist each other in getting the drug registered in not only Mexico but also in other countries.

An independent board – called the Independent Data and Safety Monitoring Board (DSMB) – found that patients could tolerate a single dose of either 15 mcg or 45 mcg of the vaccine only. Using such dose also ensured that the patients could achieve the highest level of immunogenicity from the H1N1 virus. The DSMB also proposed that the participant size for the second stage of the Phase 2 trial should be 3000. In addition, the board suggested that the participants be given a single dose of 15 mcg. The company expects to start the second stage soon, after disclosing the complete data from the first stage.

Dr. Rahul Singhvi, who is Chief Executive Officer and also the President of Novavax Inc., said:

“We believe this is the best possible outcome for our vaccine development program because it suggests that a single 15 mcg dose of our 2009 H1N1 VLP pandemic influenza vaccine will be well tolerated, immunogenic and competitive with currently marketed H1N1 influenza vaccines which are being administered at the same dose. The trial’s speedy turnaround from start of enrollment on October 19, 2009 to data review in less than six weeks is a testament to the enormous dedication of the Mexican-U.S. team. It is also clear evidence of what Novavax’s technology is capable of providing as a rapid response to a pandemic situation. The DSMB’s decision will enable us to begin enrollment in the second stage of this trial immediately and begin final preparations for possible registration and commercialization of this promising vaccine in Mexico and potentially other countries.”

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