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Alnylam Reports Results of Human Experimental Infection Model with,Respiratory Syncytial Virus

significant advance for the development of novel anti-RSV therapies. Importantly, with an experimental infection model in hand, we now have the ability to demonstrate the anti-viral activity for RNAi therapeutics in a well-controlled Phase II human trial. We expect to have data with ALN-RSV01 from this trial in the second half of the year."

"Based on the Phase I studies to date, the encouraging pre-clinical data showing anti-viral activity, and the drug's novel mechanism of action, ALN-RSV01 may represent a breakthrough treatment option for patients infected with RSV," said John P. DeVincenzo, M.D., Associate Professor of Pediatrics and Infectious Diseases at the University of Tennessee Health Science Center. "Establishing a safe, reliable RSV infection in human volunteers, and being able to quantify the infection and the symptoms it produces is a significant accomplishment. In the months to come, I look forward to the initiation of a Phase II trial for ALN-RSV01, where we will have the opportunity to demonstrate anti-viral activity in man."

ALN-RSV01 is an RNAi therapeutic being developed for the treatment of RSV infection, a prevalent viral infectious disease in pediatric and several adult patient populations. ALN-RSV01 was found to be safe and well tolerated when administered intranasally in clinically relevant doses to human adult volunteers in a Phase I study where it demonstrated a safety profile comparable to placebo. A Phase I inhalation safety study with a nebulized formulation of ALN-RSV01 is currently enrolling subjects in the U.S.; data from this trial is now expected in the second half of 2007. ALN-RSV01 is an Alnylam proprietary program and as such, represents an important component of the company's balanced pipeline of proprietary and partnered RNAi therapeutics programs.

Phase II Experimental Infection Study Details

Alnylam will be conducting a randomized, placebo-controlled, double-blind Phase II experimental infection st
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