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

CAMBRIDGE, Mass.--(BUSINESS WIRE)--May 7, 2007 - Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, presented data from its experimental infection study at the 2007 Pediatric Academic Societies' (PAS) Annual Meeting being held in Toronto. This study represents an important component of the company's clinical development program for ALN-RSV01, an RNAi therapeutic for the treatment of respiratory syncytial virus (RSV) infection. Results demonstrated the establishment of a safe and reliable RSV infection in the upper respiratory tract of adult volunteers and as a result of this achievement, the company expects to begin a Phase II study evaluating the safety and efficacy of ALN-RSV01 in experimentally infected adults in the second quarter of this year.

The experimental infection model was designed to evaluate viral infectivity of RSV administered intranasally in healthy adult volunteers. Top-line data are summarized as follows:

-- A total of 36 subjects were exposed to RSV in 5 cohorts;

-- Escalating viral inoculums were used from log 3 to log 5 plaque forming units (PFU), a measure of viral inoculum concentration;

-- Clinical and virologic signs of infection, e.g., viral load and viral shedding, were documented;

-- 72 percent of subjects were infected with a mean incubation period of 3.2 days, duration of infection of 7 days, and viral load (by an area under the curve analysis) of 61.9 log 10 PFU-days; and,

-- No significant adverse events were observed.

"We are pleased with the progress we have made to date with the clinical development of ALN-RSV01, an RNAi therapeutic for the treatment of RSV," said Akshay Vaishnaw, M.D., Ph.D., Vice President, Clinical Research of Alnylam. "Experimental infection models have been used to develop many anti-viral treatments including those for flu and the common cold, and we believe that such a model is a
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