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Transave, Inc. Receives $2.2 Million Cystic Fibrosis Foundation Award for Development of ARIKACE(TM)


6/25/2009 10:39:42 AM

Company Also Receives Patent Covering ARIKACE for Once-Daily Treatment of Pseudomonas Lung Infections

MONMOUTH JUNCTION, N.J., June 25 /PRNewswire/ -- Cystic Fibrosis Foundation Therapeutics Inc., the nonprofit affiliate of the Cystic Fibrosis Foundation, has provided a $2.2 million award to Transave Inc., for the continued development of ARIKACE(TM) (liposomal amikacin for inhalation), an antibiotic that aims to treat Pseudomonas lung infections in cystic fibrosis (CF) and non-CF bronchiectasis patients. Transave announced today that the award will be used to support an ongoing Phase II clinical trial in U.S. CF patients with Pseudomonas lung infections and a preclinical study. The company also reported today completion of enrollment for its second CF Phase II clinical trial; results are expected to be available in July. The first CF Phase II trial, completed in June 2008, achieved positive results.

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 Robert J. Beall, Ph.D., President and CEO of the Cystic Fibrosis Foundation. "The potential for ARIKACE is encouraging, both in terms of possible lung function improvements and quality of life outcomes."

Under the terms of the agreement, Transave stands to receive $2.2 million upon achievement of certain milestones. Cystic Fibrosis Foundation Therapeutics provided a previous award of $1.7 million to support the development of ARIKACE.

"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 Tim Whitten, Transave's President and Chief Executive Officer. "We are grateful for the continued support of the CF Foundation as we strive to improve treatment options for CF patients."

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 the United States are participating in the study.

About ARIKACE(TM)

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 another Phase II trial in which ARIKACE is being evaluated in the treatment of non-CF patients who have bronchiectasis with Pseudomonas lung infections. In the bronchiectasis trial, 64 adult patients were randomized 2:1 to two doses -- either 280 mg or 560 mg of ARIKACE or placebo for 28 days followed by a 28-day off-treatment observation period. Sixteen clinical sites throughout Europe and India are participating in the bronchiectasis study.

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 The Cystic Fibrosis Foundation

The Cystic Fibrosis Foundation, the leading organization in the United States devoted to curing and controlling cystic fibrosis, has invested more than $320 million in drug research with biotech companies since 1998 to develop therapies to fight CF. As a result, the Foundation has built a drug pipeline with more than 30 promising therapies in development. Virtually every approved CF therapy available today was made possible because of the support of the Foundation. Based in Bethesda, MD, the Foundation has 80 chapters and branch offices, and supports and accredits a nationwide network of 110 CF care centers that provide treatment and vital resources to patients and families. For more information, visit www.cff.org.

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.

CONTACT: Jennifer Corrigan, +1-732-382-8898, Jenn.corrigan@comcast.net,
for Transave, Inc.

Web site: http://www.transaveinc.com/


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