Transave Enters Into Cooperative Research Agreement With NIH To Study ARIKACE(TM) In Nontuberculous My...( MONMOUTH JUNCTION N...)

MONMOUTH JUNCTION, N.J., July 30 /PRNewswire/ -- Transave Inc. announced today that it has entered into a cooperative research and development agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), to study ARIKACE(TM) (liposomal amikacin for inhalation) in patients with nontuberculous mycobacteria (NTM) lung infections.

Transave and NIAID will collaborate on the planning, design and implementation of a clinical trial to evaluate ARIKACE in patients with NTM lung disease who have failed to respond to standard, guideline-based treatment regimens. The study will assess the safety and tolerability of ARIKACE versus placebo administered once daily for several continuous months using an investigational eFlow(R) Nebulizer System (PARI Pharma GmbH), a novel, highly efficient and portable aerosol delivery system. About 35 patients will be enrolled in the trial to be conducted at the NIH Clinical Center in Bethesda, MD.

"This is the third type of chronic lung infection for which ARIKACE is being evaluated," said Tim Whitten, chief executive officer of Transave. "The preliminary success with ARIKACE demonstrating a sustained clinical benefit in treating cystic fibrosis (CF) patients with Pseudomonas lung infections is encouraging as we tackle this additional disease state in collaboration with NIAID."

There is no clear evidence on what triggers NTM disease, but the bacteria are commonly found in potable water and in soil, and it has been associated with lung disease in certain patients. Transave estimates that there are at least 30,000 patients suffering with NTM lung disease in the United States. Current treatment requires lengthy multi-drug regimens that are often poorly tolerated and not very effective, especially in patients with severe disease or in those who have failed prior treatments
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