« Return to News | Clinical Intelligence

Grifols initiates safety study of inhaled alpha1-proteinase inhibitor for CF

Thursday, July 19, 2012 01:18 PM

Grifols, a global healthcare company based in Barcelona, Spain, plans to initiate a safety trial of a novel, inhaled formulation of alpha1-proteinase inhibitor [human] later this year.  In April, the FDA granted orphan drug designation for Grifols' inhaled alpha1 formulation as a treatment for cystic fibrosis, an inherited disease that can cause life-threatening lung infections. Orphan drug designation is granted to encourage the development of treatments that prevent, diagnose or treat rare diseases that affect fewer than 200,000 people per year in the U.S.

"Grifols is committed to developing new therapies that address the debilitating symptoms of chronic lung disease," said Kim Hanna, vice president of clinical research development. "The orphan drug designation represents another milestone in the growth of our alpha1 program, and we're excited to pursue clinical trials with an aerosol formulation of this important therapy."

Grifols currently has the intravenous therapy PROLASTIN-C (Alpha1-Proteinase Inhibitor [Human])(A1-PI), indicated for the treatment of alpha1-antitrypsin (AAT) deficiency. This rare, genetic disorder can result in the development of emphysema due to low circulating levels of the alpha1 protein in the lungs.

PROLASTIN, the predecessor to PROLASTIN-C, was the first FDA-approved product to treat AAT deficiency and remained so for nearly 17 years. Grifols is developing its next-generation alpha­1-proteinase inhibitor as an inhaled formulation.

 

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

Already a subscriber?
Log in to your digital subscription.

Purchase the January issue.

Subscribe to The CenterWatch Monthly.

December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

Already a subscriber?
Log in to your digital subscription.

Purchase the December issue.

Subscribe to The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.