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PARI's eFlow Delivers Alnylam RNAi Therapeutic in Phase I Study
Date:12/13/2007

MONTEREY, Calif., Dec. 13 /PRNewswire/ -- PARI's eFlow, an advanced electronic nebulizer, was optimized and used to deliver Alnylam's ALN-RSV01 in a Phase I human clinical trial. Results of the Phase I trial were announced today at the 18th Annual Drug Delivery to the Lungs meeting held in Edinburgh, U.K. ALN-RSV01 is an RNAi therapeutic being developed as a treatment for respiratory syncytial virus (RSV) infection, the leading cause of pediatric hospitalization in the U.S. and a prevalent infection in immune-compromised adults. RSV currently does not have a viable treatment option. The Phase I study represents the first-ever clinical study of an RNAi therapeutic administered via inhalation.

"With the flexibility of the eFlow platform, we are collaborating with a number of pharmaceutical companies to develop new respiratory therapies that are delivered to the lungs in a faster, more effective manner. We hope that working with Alnylam on a treatment for RSV will open up a new treatment option to meet this unmet need," said Geoff Hunziker, President of eFlow LLC.

Alnylam's Phase I study for ALN-RSV01 was a randomized, double-blind, placebo-controlled trial in healthy adult volunteers to assess the safety, tolerability, and pharmacokinetics of ALN-RSV01 administrated by inhalation via nebulizer. All major objectives of the trial were met, including definition of a safe and well-tolerated dose and regimen for advancement of ALN-RSV01 into further Phase II development. Importantly, data showed that the efficiency of delivery of ALN-RSV01 delivered via inhalation, as measured by plasma levels, was significantly greater in humans than observed pre-clinically.

Respiratory syncytial virus (RSV) is a highly contagious virus that causes infections in the upper and lower respiratory tract associated with predictable seasonal outbreaks worldwide. RSV infection is the most common cause for infant hospitalization (more than 100,000 hospitalizations annu
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SOURCE PARI Pharma
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