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Positive Data From Lung Study May Lead to First FDA Approved Treatment for Pulmonary Fibrosis

CPF Calls on Manufacturer and FDA to Expedite Review of Pirfenidone as Treatment for PF

SAN JOSE, Calif., Feb. 4 /PRNewswire-USNewswire/ -- The Coalition for Pulmonary Fibrosis (CPF) is calling this a historic time in the research and treatment of PF, as a pivotal Phase III clinical trial is completed for <!-- ppurl -->Pirfenidone <!-- /ppurl -->and data released. The positive data could pave the way for the first FDA-approved therapy to treat PF - a relentlessly progressive and ultimately fatal lung disease affecting more than 128,000 people and claiming 40,000 lives each year. The CPF urges the FDA to review this study as soon as possible, given that there are no current FDA-approved treatments for PF.
 

"For patients living with a lethal and ultimately fatal disease, these data indicate that Pirfenidone may allow them breathe better, walk further, and live longer," said CPF Founder and Chief Operating Officer Mark Shreve. "If approved, Pirfenidone would represent a historic and desperately needed advance in the treatment of PF."
 

This milestone in research for PF treatments takes on particular meaning for the CPF which has long advocated on behalf of researchers and patients for accelerated research to treat and cure PF, both by the pharmaceutical industry and research funded by the National Institutes of Health (NIH). The CPF has also directly funded emerging research at several of the nation's leading centers for the treatment and study of PF including The University of Chicago, University of Michigan, and the David Geffen School of Medicine at UCLA and directed more than $400,000 in combined research funding since 2006 through its partnership with the American Thoracic Society (ATS). Complete details on CPF activities, including research, are available on our web page at: http://www.coalitionforpf.org/cpf_accomplishments.php.
 

"While this study does not represent a cure, it IS a historic first step in treating PF, and is a shining ray of hope for the thousands of patients suffering from this terrible disease," said Mishka Michon, Chief Executive Officer of the CPF.
 

"Unfortunately due to the regulatory process, another 40,000 patients will die this year from PF while this application is submitted and reviewed by the FDA. We call on the FDA and the manufacturer to make every possible effort to expedite this process, so that more lives may possibly be saved," Shreve said.
 

About Pulmonary Fibrosis (PF)
 

Pulmonary Fibrosis (PF) is a lung disorder characterized by a progressive scarring - known as fibrosis -- and deterioration of the lungs, which slowly robs its victims of their ability to breathe. Approximately 128,000 Americans suffer from PF, and there is currently no known cause or cure. An estimated 48,000 new cases are diagnosed each year. PF is difficult to diagnose and an estimated two-thirds of patients die within five years of diagnosis. Sometimes PF can be linked to a particular cause, such as certain environmental exposures, chemotherapy or radiation therapy, residual infection, or autoimmune diseases such as scleroderma or rheumatoid arthritis. However, in many instances, no known cause can be established. When this is the case, it is called idiopathic pulmonary fibrosis (IPF).
 

About the CPF
 

The CPF is a 501(c)(3) nonprofit organization, founded in 2001 to accelerate research efforts leading to a cure for pulmonary fibrosis (PF), while educating, supporting, and advocating for the community of patients, families, and medical professionals fighting this disease. The CPF funds promising research into new approaches to treat and cure PF; provides patients and families with comprehensive education materials, resources, and hope; serves as a voice for national advocacy of PF issues; and works to improve awareness of PF in the medical community as well as the general public. The CPF's nonprofit partners include many of the most respected medical centers and healthcare organizations in the U.S. With more than 17,000 members nationwide, the CPF is the largest nonprofit organization in the U.S. dedicated to advocating for those with PF. For more information please visit www.coalitionforpf.org or call (888) 222-8541.
 

Source: Coalition for Pulmonary Fibrosis

CONTACT: Teresa Barnes of the Coalition for Pulmonary Fibrosis, Mobile:
+1-303-521-4080 or +1-888-222-8541, ext. 702, tbarnes@coalitionforpf.org
 

Web Site: http://www.coalitionforpf.org/
 

Posted: February 2009

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