NAPSR news: Revolutionary Cystic Fibrosis Combination Treatment Clears Phase 3 Studies for Vertex

WASHINGTON - June 24, 2014 - PRLog -- Vertex received a significant scientific breakthrough with a new cystic fibrosis combo treatment successfully clearing the Phase three trial.  The combination of Lumacaftor  with Ivacaftor  met the desired endpoint represented by statistical significant improvements in lung function (FEV1) in people 12 years or older with cystic fibrosis who have two copies of the F508del mutation.

Cystic fibrosis is caused by defective or missing CFTR proteins at the cell surface that result from mutations in the CFTR gene and unfortunately there is no known cure for this devastating genetic disease.  The mutated or absent CFTR proteins in people with CF results in poor flow of salt and water into and out of the cell in a number of organs, including the lungs. People carrying the two copies of the F508del mutation gene lose approximately 2% of their lung function every year.

According to the company, Lumacaftor is designed to address the processing defect of F508del-CFTR to enable it to reach the cell surface where Ivacaftor can further enhance the protein's function. Individuals who have two copies of the F508del mutation involve the CFTR protein not being processed, or folded, normally within the cell which typically does not reach the cell surface. In North America, Europe and Australia, there are more than 22,000 people ages 12 and older who have two copies of the F508del mutation.

"The combination of lumacaftor and ivacaftor is the first regimen designed to address the underlying cause of CF for people with the most common form of the disease, and based on these data, we plan to move as fast as possible to submit applications for approval of this combination regimen in countries around the world," said Jeffrey Chodakewitz, M.D., Senior Vice President and Chief Medical Officer at Vertex. "I would like to thank the more than 1,100 people who took part in these studies worldwide, as well as their families, friends and caregivers."

"These data mark an exciting day for the CF community and validate our more than 30-year commitment to develop medicines that target the underlying basic defect of cystic fibrosis for all people with this devastating disease," said Robert J. Beall, Ph.D., President and CEO, Cystic Fibrosis Foundation. "While we await the FDA's review of these data, we're grateful to the many people with CF, families and volunteers who have committed their time and resources to help accelerate our efforts to bring effective therapies to all people living with the disease."

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