Navigation Links
Interim Analysis of Top-Line Data From Phase II/III Study Shows Favorable Efficacy & Safety for Corthera's Relaxin in Acute Heart Failure
Date:11/10/2008

SAN MATEO‚ Calif.‚ Nov. 10 /PRNewswire/ -- Corthera Inc. today announced that an interim analysis of top-line data from Pre-RELAX-AHF, the Phase II portion of a Phase II/III multicenter, randomized, double-blind, international study, showed favorable efficacy and safety for relaxin, the company's investigational drug for treatment of acute heart failure.

The interim Phase II results were presented by John R. Teerlink, M.D., Professor of Medicine, University of California San Francisco, in a satellite symposium at the American Heart Association's (AHA) Scientific Sessions 2008 in New Orleans. The data from the first 209 patients enrolled in the trial demonstrated beneficial trends in acute heart failure (AHF) signs, symptoms and outcomes with no evidence of renal toxicity. Relaxin appeared safe and well-tolerated over a wide dose range.

"The data indicate that relaxin is a very promising treatment for AHF," said Teerlink, co-principal investigator of the study. "Compared to placebo, relaxin's effect on the important endpoint of relieving dyspnea, breathlessness, was apparent within 6 hours after start of treatment. These initial effects lasted up to 14 days after treatment, something not previously seen with other therapies for AHF. Relaxin's safety profile in the study's patient population was benign during and following drug treatment, while blood pressure effects were predictable and manageable. There were also encouraging trends in other in-hospital endpoints, including weight-loss due to diuresis, incidence of worsening heart failure and length of hospital stay. The consistency of these improvements across multiple measures of outcomes is very encouraging."

Corthera's Pre-RELAX-AHF/RELAX-AHF study is a Phase II/III, 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 the Phase II Pre-RELAX-AHF study, the objective was proof-of-concept and dose and endpoint selection. In Phase III RELAX-AHF, the objective is to confirm safety and efficacy. Patients selected for the study presented to the hospital with dyspnea (breathlessness) due to AHF and with elevated blood pressure and renal dysfunction. The Pre-RELAX-AHF/RELAX-AHF study was designed and conducted in collaboration with Momentum Research, headed by Dr. Gad Cotter.

Marco Metra, M.D., Professor of Cardiology at the University of Brescia, Italy, and co-principal investigator of the Pre-RELAX-AHF study, was also a speaker at the symposium. "Patients with AHF remain a major clinical challenge with extremely high morbidity and mortality rates. Promising new agents such as relaxin are needed to treat these patients and improve their outcomes. The data from the Phase II study met the objectives of the proof-of-concept Pre-RELAX-AHF study, allowing the selection of the appropriate dose and endpoints for further study. Progression to the Phase III portion of the study is now clearly warranted," said Dr. Metra.

According to the AHA, heart failure is a costly syndrome contributing to more than three million hospitalizations each year in the U.S. The great majority of patients with acute heart failure 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. 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. Data from the Pre-RELAX study, as well as a pilot study in patients with heart failure, support the expectation that these effects may be beneficial in relieving the signs and symptoms of heart failure.

About Corthera

Corthera Inc. is a 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 acute heart failure. Corthera has worldwide rights to develop and commercialize relaxin.

About Momentum Research

Momentum Research, Inc. is a consulting and management organization with clinical expertise and leadership dedicated to the development of cardiovascular products and studies. For more information go to http://www.momentum-research.com

Contact: Andreas Marathovouniotis or Ian Stone

Russo Partners

212.845.4235 or 619.814.3510

andreas.marathis@russopartnersllc.com

ian.stone@russopartnersllc.com


'/>"/>
SOURCE Corthera Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Interim Analysis of Data from e-HEALING Registry of OrbusNeichs Genous(TM) Bio-engineered R stent(TM) to be Presented at AHA Scientific Sessions 2008
2. Oncolytics Biotech Inc. Investigators Present Interim U.S. REOLYSIN(R) Phase II Sarcoma Trial Data
3. Misonix Announces Interim Distribution Agreement for Italy
4. Nile Therapeutics Announces Positive Interim Data from Phase 2a Study of CD-NP in Patients with Heart Failure
5. Exiqon A/S: Interim Report for the Period 1 January - 30 June 2008 (Unaudited)
6. Arpida Reports Interim Results for Six Months to 30 June 2008
7. Bavarian Nordic A/S - Interim Report for the Period 1 January to 30 June 2008
8. LPBP Inc. - Re-filing certification of interim filings
9. Fufeng Announces 2008 Interim Results With Strong Sign of Recovery
10. BioMS Medical announces positive interim analysis on phase III trial of dirucotide (MBP8298) for multiple sclerosis
11. Chromos obtains interim order in connection with arrangement, announces annual and special meeting of shareholders and confirms mailing of information circular
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... ... 2016 , ... Charm Sciences, Inc. is pleased to announce ... Research Institute approval 061601. , “This is another AOAC-RI approval of the Peel ... President of Regulatory and Industrial Affairs. “The Peel Plate methods perform comparably to ...
(Date:6/23/2016)... ON (PRWEB) , ... June 23, 2016 , ... STACS ... DNA Technical Leader at the Arkansas State Crime Laboratory, has joined STACS DNA as ... the STACS DNA team,” said Jocelyn Tremblay, President and COO of STACS DNA. “In ...
(Date:6/23/2016)... On Wednesday, June 22, 2016, the NASDAQ Composite ... Jones Industrial Average edged 0.27% lower to finish at 17,780.83; ... has initiated coverage on the following equities: Infinity Pharmaceuticals Inc. ... NKTR ), Aralez Pharmaceuticals Inc. (NASDAQ: ARLZ ), ... more about these stocks by accessing their free trade alerts ...
(Date:6/23/2016)... , June 23, 2016 ... market research report to its pharmaceuticals section with ... product details and much more. Complete ... across 151 pages, profiling 15 companies and supported ... at http://www.reportsnreports.com/reports/601420-global-cell-culture-media-industry-2016-market-research-report.html . The ...
Breaking Biology Technology:
(Date:5/20/2016)...  VoiceIt is excited to announce its new ... By working together, VoiceIt and VoicePass will offer ... take slightly different approaches to voice biometrics, collaboration ... usability. Both ... "This marketing and technology partnership allows ...
(Date:5/9/2016)... , UAE, May 9, 2016 ... it comes to expanding freedom for high net worth ... Even in today,s globally connected world, there is still ... system could ever duplicate sealing your deal with a ... second passports by taking advantage of citizenship via investment ...
(Date:4/28/2016)... , April 28, 2016 First quarter ... (139.9), up 966% compared with the first quarter of 2015 ... totaled SEK 589.1 M (loss: 18.8) and the operating margin was ... (loss: 0.32) Cash flow from operations was SEK 249.9 ... 2016 revenue guidance is unchanged, SEK 7,000-8,500 M. The ...
Breaking Biology News(10 mins):