PARI's eFlow Delivers Alnylam RNAi Therapeutic in Phase I Study
MONTEREY, Calif., December 13, 2007 /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 annually in the U.S.), and the virus is a significant pathogen in the elderly. The RNAi therapeutic agent ALN-RSV01 is a small interfering ribonucleic acid (siRNA) targeting the messenger RNA of the RSV N gene to prevent viral replication. To deliver ALN-RSV01 to the site of infection, the siRNA is being administered as an aerosol in a highly efficient pulmonary delivery system, the optimized eFlow(R) electronic nebulizer, with high drug output, optimized droplet size, and low residual drug loss.
eFlow, an electronic, portable nebulizer, enables extremely efficient aerosolization of liquid medications via a vibrating, perforated membrane. Compared to other nebulizer systems, eFlow can produce aerosols with a very high density of active drug, a precisely defined droplet size, and a high proportion of respirable droplets delivered in the shortest possible amount of time. Combined with its silent mode of operation, small size (it fits in the palm of your hand), light weight, and battery use, eFlow helps reduce the burden of taking daily inhaled treatments.
About PARI Pharma
PARI Pharma develops aerosol delivery devices and inhaled therapies. Based on PARI's 100-year history working with aerosols, PARI Pharma specializes in treatments for pulmonary and nasal administration optimized to advanced delivery platforms, such as eFlow.
Focusing on comprehensive inhalation therapy development, including optimized nebulizer formulations, analytics, and aerosol characterization, PARI Pharma has several clinical development programs ongoing, either partnered or proprietary. PARI Pharma, a PARI Medical Holding company, is located in Munich, Germany, with a major presence in the United States. Online at http://www.paripharma.com
CONTACT: Kirsten Ayars, +1-805-452-7909, or Geoff Hunziker at+1-831-372-3580, both for PARI Pharma
Web site: http://www.paripharma.com//
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Posted: December 2007