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. Few clinical trials are under way to identify treatment recommendations, and no new drugs have been assessed for this disease in many years.
"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."
ARIKACE is a sustained-release formulation of the antibiotic amikacin, which encloses the drug in nanocapsules of lipid called liposomes. This advanced pulmonary liposome technology prolongs the release of amikacin in the lungs while minimizing systemic exposure. The treatment uses biocompatible lipids endogenous to the lung that are formulated into small (0.3 micron), neutral liposomes that enable penetration of the biofilm and are highly efficient, with a very low lipid-to-drug ratio (0.65). ARIKACE can be delivered through nebulization, which enables the small aerosol droplet size (1 to 5 microns) to facilitate more effective distribution in the lungs.
Positive Phase II results were announced in June 2008 from a clinical trial in European CF patients with Pseudomonas lung infections. The company also previously announced completion of enrollment in two additional Phase II trials including a study where ARIKACE is being evaluated in the treatment of non-CF patients who have bronchiectasis with Pseudomonas lung infections and a second trial in U.S. CF patients with Pseudomonas lung infections.
ARIKACE has been granted orphan drug status in the United States by the FDA, and has received an orphan drug designation in Europe by the European Medicines Agency for the treatment of Pseudomonas infections in patients with CF.
About PARI Pharma and the Investigational eFlow((R)) Nebulizer System
ARIKACE is delivered by an investigational eFlow Nebulizer System developed by PARI Pharma GmbH. The investigational eFlow Nebulizer System uses eFlow Technology to enable highly efficient aerosolization of medication including liposomal formulations via a vibrating, perforated membrane that includes thousands of laser drilled holes. Compared to other nebulization technologies, eFlow Technology produces 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 period of time. Combined with its silent mode of operation, small size (it fits in the palm of the hand), light weight, and battery use, products incorporating eFlow Technology reduce the burden of taking daily, inhaled treatments. The investigational eFlow Nebulizer System and eFlow Technology are proprietary to PARI Pharma and can be optimized to specific drug formulations.
About Transave, Inc.
Transave, Inc., is a biopharmaceutical company focused on the development of innovative inhaled pharmaceuticals for the site-specific treatment of chronic lung diseases. The company's major focus is on developing antibiotic therapy delivered via proprietary advanced pulmonary liposome technology in areas of high unmet need in lung diseases. The Transave team is dedicated to leveraging its development and commercialization expertise, along with its intellectual property, to bring life-extending and life-enhancing medicines to patients. For more information about Transave's technology and development programs, visit www.transaveinc.com.
|SOURCE Transave, Inc.|
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