Navigation Links
Corthera's Relaxin Receives FDA Fast Track Designation for the Treatment of Acute Heart Failure
Date:10/1/2009

SAN MATEO' Calif.' Oct. 1 /PRNewswire/ -- Corthera Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to relaxin, the company's investigational drug for the treatment of acute heart failure (AHF). The Fast Track program facilitates the development and expedites the review of new drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

"Fast Track designation for the relaxin heart failure program is an important acknowledgement by the FDA of the need for advancements in the treatment of AHF," said Stan Abel, CEO of Corthera. "We are excited to be launching Phase 3 given our goal of advancing the development of relaxin as rapidly as possible for the benefit of patients who are in need of new treatment options."

Corthera's completed Pre-RELAX-AHF study is the Phase 2 portion of a Phase 2/3, multicenter, randomized, double-blind, placebo-controlled, parallel-group, international trial designed to evaluate the efficacy and safety of relaxin for the treatment of AHF. In Pre-RELAX-AHF, the objective was proof-of-concept and dose and endpoint selection. Data from the Phase 2 study were presented at the American College of Cardiology conference earlier this year and published in the medical journal, The Lancet. These data from 234 patients in eight countries showed that when administered with standard-of-care therapy for AHF, patients receiving relaxin had greater and longer-lasting relief of dyspnea (shortness of breath). Relaxin treatment was associated with consistent trends in improvement of the hospital course of patients, prevention of heart failure worsening during hospitalization, shortening of in hospital stay and improved longer-term outcomes following discharge when compared to placebo. Corthera is currently initiating enrollment in the Phase 3 RELAX-AHF study, the objective of which is to confirm the promising safety and efficacy of relaxin seen in these patients. The Pre-RELAX-AHF / RELAX-AHF study was designed and conducted in collaboration with Momentum Research, headed by Dr. Gad Cotter, a noted heart failure expert.

"Patients with acute heart failure remain a major clinical challenge with very high morbidity and mortality rates and limited treatment options," said John R. Teerlink, M.D., Professor of Medicine, University of California San Francisco, Director of Heart Failure, Veterans Affairs Medical Center, San Francisco, and co-principal investigator of the studies. "The importance of this Fast Track designation is two-fold as it acknowledges a significant unmet medical need and recognizes relaxin's potential as an important treatment option for patients with AHF."

According to U.S. data, there are more than 3 million hospital discharges each year with heart failure as a diagnosis, with significant short-term rehospitalization and one-year mortality rates. It is the single largest expense to Medicare, accounting for more than $13 billion in hospitalization costs. The great majority of acute heart failure patients have fluid accumulation in the lungs (congestion) that causes shortness of breath (dyspnea) and other complications. For these patients, the current standard of care includes diuretics and vasodilators. Available agents from both of these classes of agents have been associated with renal impairment, hypotension and adverse outcomes.

About Relaxin

Relaxin is a naturally occurring peptide hormone that acts as a systemic and renal vasodilator. Elevated levels of relaxin modulate increases in renal and cardiac function that meet the increased hemodynamic demands of pregnancy. Consistent with this natural role of the hormone, pharmaceutically manufactured relaxin has been shown to have these effects in multiple human studies of men and non-pregnant women, including patients with heart failure.

About Corthera

Corthera Inc. is a private biopharmaceutical company committed to acquiring, developing and commercializing therapies for illnesses in the acute care setting. Corthera's lead product candidate, relaxin, is currently being evaluated in clinical trials for the treatment of acute heart failure. The company has worldwide rights to develop and commercialize relaxin. For more information, visit www.corthera.com.

    Contact:   Andreas Marathovouniotis or David Schull
               Russo Partners
               (212) 845-4235
               (212) 845-4271
               andreas.marathis@russopartnersllc.com
               david.schull@russopartnersllc.com

SOURCE Corthera Inc.


'/>"/>
SOURCE Corthera Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Results and Additional Analyses From Study Show That Cortheras Relaxin for Acute Heart Failure is the Strongest Predictor of Improved Longer-Term Outcomes Following Hospital Discharge When Compared to Other Variables
2. Results and Additional Analyses From Efficacy and Safety Study of Cortheras Relaxin in Acute Heart Failure to be Presented at Heart Failure Congress 2009
3. Results From Study Show Promising Efficacy and Safety Results for Cortheras Relaxin in Acute Heart Failure
4. Results From Efficacy and Safety Study of Cortheras Relaxin in Acute Heart Failure to be Presented at Late-Breaking Clinical Trials Session at ACC 58th Annual Scientific Session
5. Corthera Initiates Phase II Clinical Trial of Relaxin in Acute Heart Failure
6. Sigma-Aldrich(R) Receives Award From Michael J. Fox Foundation to Develop Parkinsons Disease Research Models
7. Mylan Receives FDA Approval for Generic Version of Parkinsons Treatment Sinemet(R)
8. GenVec Receives National Cancer Institute Grant to Expand Cancer Program
9. Hologic Receives CE Marking for the ThinPrep(R) Integrated Imager
10. Oxygen Biotherapeutics, Inc. Receives Phase II Trial Approval in Israel
11. Childrens Hospital Receives Six-Year Federal Contract to Study Antibiotic Use in Children With Urinary Tract Infections
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/25/2016)... MedDay, a biotechnology company focused on the treatment ... "High doses of biotin in progressive multiple sclerosis: extension phase ... Ayman Tourbah , Principal Investigator of the Phase 3 ... Neurology (EAN) in Copenhagen, Denmark . The ... on Sunday, 29 May 2016 from 14:45 to 16:15 CEST ...
(Date:5/25/2016)... , May 25, 2016 ... 2016"market research report that provides an overview on ... analysis at various stages, therapeutics assessment by drug ... (RoA) and molecule type, along with latest updates, ... reviews key players involved in the therapeutic development ...
(Date:5/24/2016)... 24, 2016 Cirujanos holandeses han ... a los médicos a compartir sus mejores prácticas por ... mundial. Profesionales médicos de Europa, África, Asia ... a la aplicación, que combina la transmisión en vivo ... seguro. Educación   "Imagine un médico ...
Breaking Medicine Technology:
(Date:5/27/2016)... ... May 27, 2016 , ... W.S. Badger Co. Inc ., the ... has been recognized as one of the best small businesses for new dads by ... of nine small businesses providing progressive benefits to new parents on the organization’s ...
(Date:5/27/2016)... ... , ... With over 60 percent of acute stroke survivors being left unable ... aid in the rehabilitation process has steadily increased. Ekso Bionics had been working to ... to stroke. , Ekso Bionics has now received clearance from the U.S. Food and ...
(Date:5/27/2016)... (PRWEB) , ... May 27, 2016 , ... ... readers, this installment is bolstered by inspiring human-interest stories, courtesy of awareness-driven celebrities ... within the industry, from leading advocates, associations and industry leaders such as Bioness. ...
(Date:5/27/2016)... , ... May 27, 2016 , ... Beleza Medspa ... body fat composition regulations. This is the first time that Coolsculpting is being ... at least every six months to ensure they meet the prescribed body-fat standard, measured ...
(Date:5/27/2016)... ... May 27, 2016 , ... Aimed at nurses and ... stories, which come courtesy of leaders in the nursing and health care industry. It ... advocates and associations—namely Abilene Christian University. , As the nursing industry is coming ...
Breaking Medicine News(10 mins):