Transave Inc, Monmouth Junction, NJ, 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™(liposomal amikacin for inhalation) in patients with nontuberculous mycobacteria (NTM) lung infections.
According to a release from the company, “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.” Roughly 35 patients will be enrolled in a trial to assess the safety and tolerability of ARIKACE versus placebo administered once daily for several continuous months using an investigational eFlow Nebulizer System (PARI Pharma GmbH). The study will 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 patients with Pseudomonas lung infections is encouraging as we tackle this additional disease state in collaboration with NIAID."
"Patients with Mycobacterium avium complex or Mycobacterium abscessus lung disease have limited options, which is why we welcome the opportunity to collaborate with NIAID to study this new treatment," said Renu Gupta, MD, Transave’s executive vice president for development and chief medical Officer. "ARIKACE is an excellent candidate to study in these infections based on the successful Phase II results in treating other chronic lung infections, where it demonstrated sustained release in the lung with minimal systemic exposure."
