Transave Receives $2.2 Million Cystic Fibrosis Foundation Award for Development of ARIKACE(TM)
Company Also Receives Patent Covering ARIKACE for Once-Daily Treatment of Pseudomonas Lung Infections
In other developments, the company announced that it was granted a patent for ARIKACE by the U.S. Patent and Trademark Office. U.S. Patent No. 7,544,369 entitled “Sustained Release of Antiinfectives” covers ARIKACE for the once-daily treatment of Pseudomonas lung infections.
“We have followed and supported Transave’s work in this area from the beginning, and we are excited to play a role in potentially bringing another new treatment option to CF patients,” said
Under the terms of the agreement, Transave stands to receive
“We believe ARIKACE — a once-a-day treatment with sustained effect — can be a real breakthrough in CF patients’ arduous treatment burden , and are looking forward to seeing the Phase II results and moving to Phase III soon afterward,” said
The double-blind, 3 cohort, placebo-controlled study is designed to evaluate ARIKACE in the treatment of CF patients with Pseudomonas lung infections. A total of 46 patients have been randomized. ARIKACE or placebo are administered once daily for 28 days using an eFlow(R) Nebulizer System (PARI Pharma GmbH), a novel, highly efficient, portable aerosol delivery system. Eighteen clinical sites throughout
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
ARIKACE has been granted orphan drug status in
About The Cystic Fibrosis Foundation
The Cystic Fibrosis Foundation, the leading organization in
About PARI Pharma and the eFlow(R) Nebulizer System
ARIKACE is delivered by an eFlow Nebulizer System developed by PARI Pharma GmbH. The 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 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.