CRADA covers Arikace, a sustained-release version of amikacin.
Transave is working with the NIAID to study Arikace™, a sustained-release formulation of the antibiotic amikacin, in patients with nontuberculous mycobacteria (NTM) lung infections. Under the CRADA, the organizations will collaborate on the planning, design, and implementation of a Phase I trial to evaluate the drug in patients 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 the eFlow® Nebulizer System (PARI Pharma), a portable aerosol delivery system. About 35 patients will be enrolled in the trial to be conducted at the NIH Clinical Center in Bethesda, MD.
Positive Phase II results were announced in June 2008 from a trial in European CF patients with Pseudomonas lung infections. Transave also previously completed enrollment in two Phase II trials including an evaluation of Arikace as a treatment for non-CF patients who have bronchiectasis with Pseudomonas lung infections and a U.S. study in CF patients with Pseudomonas lung infections. Arikace has been granted orphan drug status in the U.S. and Europe for the treatment of Pseudomonas infections in patients with CF.