Navigation Links
Results and Additional Analyses From Study Show That Corthera's Relaxin for Acute Heart Failure is the Strongest Predictor of Improved Longer-Term Outcomes Following Hospital Discharge When Compared to Other Variables

Data from Phase II/III Study Presented at Heart Failure Congress 2009 Demonstrate Promising Safety and Efficacy Results for Relaxin

SAN MATEO¿ Calif.¿ June 1 /PRNewswire/ -- Corthera Inc. today announced that the results and additional statistical analyses conducted from Pre-RELAX-AHF, the Phase II portion of a Phase II/III multicenter, randomized, double-blind, international study, showed that relaxin, the company's investigational drug for the treatment of acute heart failure (AHF), was the strongest independent predictor of improved longer-term outcomes following hospital discharge when compared to other variables.

The new analyses of predictors of 60-day and 180-day outcomes, which included univariate and multivariate regression analyses, were presented today by Marco Metra, M.D., professor of cardiology at the University of Brescia, Italy, and co-principal investigator of the Pre-RELAX-AHF study, during a late-breaking clinical trials session at the annual meeting of the Heart Failure Association of the European Society of Cardiology (HFA-ESC 2009) in Nice, France.

Several variables, including baseline patient characteristics, early improvement in dyspnea (breathlessness) to day five, physician-determined occurrence of worsening of heart failure (WHF) during hospitalization, increased serum creatinine during hospitalization and relaxin administration, were included in the model to determine the important predictors of the two outcome measures: 60-day cardiovascular (CV) death or re-admission for heart failure and 180-day CV death. In the 60-day multivariate analysis, relaxin treatment was the strongest predictor of less CV death or heart failure re-admission (p<0.01). Blood urea nitrogen (BUN) on admission (p=0.02) and WHF during hospitalization (p=0.02) were also significant predictors. Relaxin treatment was the only significant variable (p<0.01) in both the multivariate and univariate analyses predicting CV death at 180 days.

"These new analyses, when added to the main results of Pre-RELAX-AHF, provide further indications that relaxin may be an important new therapy for patients admitted to hospital with acute heart failure," said Dr. Metra.

Five peer-reviewed posters with data and analyses from Pre-RELAX-AHF were also presented today. The insights from these analyses provided further evidence on the types of patients who might benefit from therapy with relaxin, as well as the mechanisms by which relaxin causes these clinical benefits.

"There is a clear and urgent need for improved therapies for patients with acute heart failure," said Piotr Ponikowski, M.D., Ph.D, head of the department of cardiology at the Clinical Military Hospital in Wroclaw, Poland, a principal investigator of the Pre-RELAX-AHF study and president-elect of the Heart Failure Association of the European Society of Cardiology. "We are encouraged by the preliminary results of the Pre-RELAX-AHF study, and we look forward to confirming them in the larger Phase III study, RELAX-AHF-1."

Stan Abel, CEO of Corthera, added, "Acute heart failure is a global medical problem. The recognition of this problem by the international cardiology community underscores the important need for new therapies and the promise that relaxin holds for patients."

Dr. Metra also presented the main results from Pre-RELAX-AHF for the first time in Europe on May 31 at the Judges' Choice oral abstracts session at HFA-ESC 2009. These results were previously presented at the American College of Cardiology's (ACC) 58th Annual Scientific Session and published in the Lancet. The data from 234 patients in eight countries showed that when relaxin was administered with standard-of-care therapy for acute heart failure, relaxin caused rapid, substantial and sustained relief from dyspnea (breathlessness). Relaxin also demonstrated 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'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. Patients selected for the study presented to the hospital with dyspnea due to AHF and with normal or elevated blood pressure. In the Phase III RELAX-AHF study, the objective is to confirm safety and efficacy. 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 in the Pre-RELAX-AHF study were randomly assigned to receive intravenous relaxin at doses of 10, 30, 100, or 250 mcg/kg/day or placebo for two days. The study indicated that the 30-mcg/kg dose of relaxin (relaxin-30) was the most effective. More patients, approximately 40%, reported moderate or marked improvements in dyspnea at six, 12 and 24 hours when treated with relaxin-30, as compared to 23% of patients assigned to placebo (p=0.04). Relief remained significantly greater at day 14. Researchers also noted trends with relaxin toward greater weight loss, less need for intravenous diuretics, and less worsening of heart failure in the hospital. When all of the doses of relaxin were compared with placebo, hospital stay was one to two days shorter. Relaxin had a good safety profile in the study.

Following 60 days, 3% of patients in the relaxin-30 group had been rehospitalized for heart failure and no patients died of cardiovascular causes, as compared to 17% in the placebo group (p=0.06), a greater than 80% reduction. After an average follow-up of four-and-a-half months, no patients in the relaxin-30 group had died of cardiovascular causes, as compared to 14% of those in the placebo group (p=0.046).

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

    Contact:    David Schull or Andreas Marathovouniotis
                Russo Partners
                (212) 845-4271
                (212) 845-4235

SOURCE Corthera Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
2. Lexicon to Present Research Results at American Chemical Society Meeting Regarding Target of LX1031 Drug Candidate
3. Positive Kuvan(TM) Pivotal Phase 3 Trial Results Published in The Lancet
4. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
5. Tapestry Reports Second Quarter 2007 Results
6. Phosphagenics Announces Positive Phase 1b Transdermal Insulin Clinical Trial Results
7. Emisphere Technologies, Inc. Announces 2007 Second Quarter Financial Results
8. Amicus Therapeutics Announces Second Quarter 2007 Financial Results
9. Genta Incorporated Announces Second Quarter 2007 Financial Results and Corporate Highlights
10. Vical Reports Second Quarter 2007 Financial Results, Allowance of Pandemic Influenza IND and Other Advances in Product Development Programs
11. MicroDose Announces Positive Results From the QDose Inhaled Insulin Glucose Clamp Study
Post Your Comments:
(Date:10/9/2015)... Oct. 9, 2015  Eli Lilly and Company (NYSE: ... has acquired worldwide rights to Locemia,s intranasal glucagon, a ... treated with insulin. Intranasal glucagon, which is currently in ... needle-free rescue treatment for severe hypoglycemia. ... a proprietary glucagon nasal powder formulation that is delivered ...
(Date:10/9/2015)... HILL, N.C. , Oct. 9, 2015 /PRNewswire/ ... or Medical Device environments, corporate communications is perpetually ... communications, corporations and professionals must continuously adjust their ... effectiveness of these adjustments is difficult, but also ... today,s communication options. --> ...
(Date:10/9/2015)... -- Regulatory affairs groups within medical device organizations face a ... These specialized groups are charged with ensuring that their ... to the development and marketing of medical device products. While ... their own internal effectiveness and efficiencies to remain productive and ... --> Optimal resourcing and staffing help ...
Breaking Medicine Technology:
... 2011 SinoFresh® HealthCare, Inc., (Pink Sheets: ... with three high volume sales agencies. These sales brokerage ... long term sales and distribution along the Eastern Corridor ... Homeopathic Nasal and Sinus Care Spray available to a ...
... 29, 2011 McNeil Consumer Healthcare, Division of McNEIL-PPC, ... Hour Extended Release Caplets 150 count bottles distributed in ... part of our ongoing surveillance and monitoring efforts that ... or moldy odor. The uncharacteristic odor is thought to ...
Cached Medicine Technology:
(Date:10/9/2015)... ... October 09, 2015 , ... The American ... Dean for Graduate Medical Education J. Michael Finley, DO, as the recipient of ... selected for his impact on graduate medical education opportunities for osteopathic residents, and ...
(Date:10/9/2015)... WASHINGTON, NH (PRWEB) , ... October 09, 2015 , ... ... Sore Throat Home Exam Aid, is now available online ( ) – just ... and Prevention (CDC) says officially begins in October. However, for many in the U.S., ...
(Date:10/9/2015)... , ... October 09, 2015 , ... ... a special promotion on Invisalign, the orthodontic system that uses clear, plastic aligners. ... are almost invisible against the teeth, which allow patients to complete treatment in ...
(Date:10/9/2015)... ... 09, 2015 , ... The Asthma and Allergy Foundation of America (AAFA) has ... Prevention (CDC) to improve the knowledge and skills of underserved adults with asthma. This ... by the CDC and allows AAFA to continue vital efforts to educate people living ...
(Date:10/9/2015)... Columbus, Ohio (PRWEB) , ... October 09, 2015 ... ... the United States, is welcoming individuals from all walks of life to save ... For the set price of $25 per month per medication, individuals and families ...
Breaking Medicine News(10 mins):
... BEIJING, June 9 /PRNewswire-Asia/ -- RainEarth Inc.,(OTC ... partner in China, Beijing RainEarth Technology Co. Ltd., ("China,RainEarth"), ... of,blood dialysis. , This second ... include: a lower broken membrane rate, a higher gap ...
... issued a position paper on the safety of HCA as ... of extracts and GarCitrin(R). This paper, which reviews and analyzes ... component hydroxycitric acid and its salts, is available to download ... . , , ...
... , WOODCLIFF LAKE, N.J., June 9 Par Pharmaceutical Companies, ... began shipping calcitonin-salmon nasal spray to the trade. Calcitonin-salmon ... . Annual U.S. sales of Miacalcin were approximately $112 ... , , Important information about calcitonin-salmon nasal spray ...
... , Center will be the first in the world to ... to deliver blood and complementary imaging tests for solid tumor ... Canary Foundation, a nonprofit organization that funds research in early ... announced their commitment of $20 million to create the Canary ...
... Electronic Pharmacy Record (EPR) to Integrate with Microsoft(R) HealthVault(TM) ... PDX and have entered into a strategic agreement ... for multiple chain and independent pharmacy clients, available to ... aggregated prescription data. The agreement enables any pharmacy using ...
... Corporation, a leader in improving caregiver workflow in healthcare environments, ... J. Rizzo to its board of directors. , , ... our board to help broaden the business and operating base ... CEO of ThinIdentity. "Both Bill and Carol will bring strong ...
Cached Medicine News:
... national reference laboratory and a worldwide leader ... offers an extensive test menu of highly ... and anatomic pathology. Owned by the University ... than half of the nation's university teaching ...
... ARUP Laboratories is a national reference ... laboratory research and development. ARUP offers an ... unique medical tests in clinical and anatomic ... ARUP Laboratories' clients include more than half ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... a national reference laboratory and a worldwide ... ARUP offers an extensive test menu of ... clinical and anatomic pathology. Owned by the ... more than half of the nation's university ...
Medicine Products: