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Dec. 12, 2012, 10:30 a.m. EST
CORRECTING AND REPLACING Gencaro(TM) Cardiovascular Effect on Patients with Atrial Fibrillation Paper Published in European Journal of Heart Failure

BROOMFIELD, Colo., Dec 12, 2012 (BUSINESS WIRE) -- First graph of release should read: ARCA biopharma, Inc. ABIO -24.68% , a biopharmaceutical company developing genetically-targeted therapies for atrial fibrillation and other cardiovascular diseases, today announced that the paper "Effect of Bucindolol (Gencaro) on Heart Failure Outcomes and Heart Rate Response in Patients with Reduced Ejection Fraction Heart Failure and Atrial Fibrillation" was published in the European Journal of Heart Failure ( www.escardio.org/journals/european-journal-heart-failure ), a publication of the Heart Failure Association of the European Society of Cardiology (sted ARCA biopharma, Inc. (Nasdaq: ABIO) announces the paper "Effect of Bucindolol (Gencaro) on Heart Failure Outcomes and Heart Rate Response in Patients with Reduced Ejection Fraction Heart Failure and Atrial Fibrillation" was published).

The corrected release reads:

GENCARO(TM) CARDIOVASCULAR EFFECT ON PATIENTS WITH ATRIAL FIBRILLATION PAPER PUBLISHED IN EUROPEAN JOURNAL OF HEART FAILURE

ARCA biopharma, Inc. ABIO -24.68% , a biopharmaceutical company developing genetically-targeted therapies for atrial fibrillation and other cardiovascular diseases, today announced that the paper "Effect of Bucindolol (Gencaro) on Heart Failure Outcomes and Heart Rate Response in Patients with Reduced Ejection Fraction Heart Failure and Atrial Fibrillation" was published in the European Journal of Heart Failure ( www.escardio.org/journals/european-journal-heart-failure ), a publication of the Heart Failure Association of the European Society of Cardiology.

The paper discusses post-hoc analyses of data from the Phase 3 clinical study of Gencaro in heart failure, known as the Beta-Blocker Evaluation of Survival Trial (BEST), which was sponsored by the National Heart, Lung and Blood Institute of the National Institutes of Health, and the Cooperative Studies Program of the Department of Veterans Affairs. These data demonstrate that patients with established atrial fibrillation (AF) in BEST who received Gencaro had improvements in heart failure clinical endpoints. Compared to placebo, the effects of Gencaro on improving heart failure clinical endpoints in the 303 patients in BEST with established AF were generally similar to the effects of Gencaro on these endpoints in the 2,176 patients in BEST with normal sinus rhythm.

The data also demonstrate that Gencaro made it more likely for patients with established AF to achieve ventricular rate control, and that Gencaro improved cardiovascular clinical endpoints for those AF patients who did achieve rate control. 67% of AF patients who received Gencaro achieved ventricular response rate control, defined as a resting heart rate of less than or equal to 80 beats per minute without symptomatic bradycardia (p < 0.005). In AF patients who achieved ventricular response rate control, Gencaro produced a 39% reduction (p = 0.025) in cardiovascular mortality/cardiovascular hospitalizations. In addition, Gencaro also improved cardiovascular clinical endpoints for those AF patients possessing the genotype which ARCA believes is most favorable for Gencaro response. In a substudy of 1,040 patients in BEST in which patient genotypes were analyzed, Gencaro was associated with a 72% decrease (p = 0.039) in cardiovascular mortality/cardiovascular hospitalizations in those 52 AF patients in the substudy with the beta-1 389 arginine homozygous genotype. ARCA believes that this genotype predicts a favorable response to Gencaro, and is estimated to be present in about 50% of the population in the U.S. These data are in contrast to the data reported for studies of other beta-blockers, including carvedilol, in which AF patients with the beta-1 389 arginine homozygous genotype who received those drugs exhibited evidence of resistance to heart rate reduction.

Christopher O'Connor, MD, Professor of Medicine and Cardiologist, Duke University Medical Center, and a co-author of the paper commented, "In placebo controlled trials of patients with heart failure and reduced left ventricular ejection fraction (HFREF) who also have permanent AF, currently approved beta blockers have not shown benefit by improving clinical endpoints. In this study, Gencaroexhibited evidence of efficacy against clinical endpoints in patients with HFREF and AF. In addition, this efficacy appears to be pharmacogenetically enhanced in patients with the beta-1 389 arginine homozygous genotype, and rate control was also effective in this genotype. This evidence of rate control by Gencaro in this genotype is important because it has been reported that other beta-blockers do not provide adequate rate control in AF patients with this genotype."

Michael Bristow, MD, PhD, President and CEO of ARCA biopharma and Professor of Medicine (Cardiology) at the University of Colorado Anschutz Medical Campus, and a senior author of the paper added, "These data from the BEST study suggest that Gencaro may be safe and effective in patients with permanent AF. ARCA would be able to further test this hypothesis in its proposed trial of Gencaro in AF prevention."

ARCA has been granted patents in the U.S., Europe, and other jurisdictions for methods of identifying and treating patients with the beta-1 389 arginine homozygous genotype. The Company plans to conduct a Phase 3 clinical trial to evaluate Gencaro as a potential treatment for the prevention of AF in patients with this genotype, subject to receiving the necessary funding.

About ARCA biopharma

ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases. The Company's lead product candidate, Gencaro(TM) (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted atrial fibrillation prevention treatment. ARCA has a collaboration with the Laboratory Corporation of America (LabCorp), under which LabCorp has developed a companion genetic test for Gencaro. For more information please visit www.arcabiopharma.com .

Safe Harbor Statement

This press release and the associated presentation may contain "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the ability of genetic variations to predict individual patient response to Gencaro, Gencaro's potential to treat atrial fibrillation, and the potential for Gencaro to be the first genetically-targeted atrial fibrillation prevention treatment. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: the Company's financial resources and whether they will be sufficient to meet the Company's business objectives and operational requirements; results of earlier clinical trials may not be confirmed in future trials, the protection and market exclusivity provided by the Company's intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA's filings with the SEC, including without limitation the Company's annual report on Form 10-K for the year ended December 31, 2011 and subsequent filings. The Company disclaims any intent or obligation to update these forward-looking statements.

SOURCE: ARCA biopharma, Inc.


       
       ARCA biopharma, Inc.
       Christopher D. Ozeroff
       Senior Vice President and General Counsel
       720-940-2100
       



Copyright Business Wire 2012  

Jan. 3, 2013, 9:00 a.m. EST
Gencaro(TM) Effect on Reducing Ventricular Arrhythmias Paper Published in Circulation: Arrhythmia and Electrophysiology

BROOMFIELD, Colo., Jan 03, 2013 (BUSINESS WIRE) -- ARCA biopharma, Inc. ABIO -24.68% , a biopharmaceutical company developing genetically-targeted therapies for atrial fibrillation and other cardiovascular diseases, today announced that the paper "Adrenergic Receptor Polymorphisms and Prevention of Ventricular Arrhythmias with Bucindolol in Patients with Chronic Heart Failure" was published in the journal Circulation: Arrhythmia and Electrophysiology [ http://circep.ahajournals.org/content/early/recent ], a publication of the American Heart Association. The lead author on the paper is cardiologist-electrophysiologist Ryan G. Aleong of the University of Colorado Anschutz Medical Campus.

The paper analyzes the overall and pharmacogenetic effects of Gencaro (bucindolol) in reducing the incidence of serious ventricular arrhythmias. The authors based their conclusions on post-hoc analyses of clinical data from a 1040 patient DNA substudy of the Phase 3 clinical trial Beta-Blocker Evaluation of Survival Trial (BEST). The BEST Trial was sponsored by the National Heart, Lung and Blood Institute of the National Institutes of Health, and the Cooperative Studies Program of the Department of Veterans Affairs.

The paper shows that patients in the BEST Trial who received Gencaro experienced a 58% reduction in the incidence of ventricular tachycardia or fibrillation ("VT/VF") (p = 0.00006), adjusted for the competing risk of mortality. In addition, the authors determined that Gencaro reduced the incidence of VT/VF by 74% (p = 0.00005) in patients with the beta-1 389 arginine homozygous genotype, believed to be present in about 50% of the U.S. population.

The study also analyzed the effect of two other genotypes on Gencaro's effect on VT/VF. Based on a statistically significant test for interaction (p = 0.03), the three genotypes provide a potential method for identifying VT/VF patients for therapy. The first group is the approximately 50% of patients with the beta-1 389 arginine homozygous genotype, who had an enhanced response (event rate reduction by 74%); the next group is the approximately 40% of patients with a second genotype (beta-1 389 glycine carriers + alpha-2C 322-325 wild type homozygous) who had an intermediate response (event rate reduction by 49%) to Gencaro; and the remaining group is the approximately 10% of patients with a third genotype (beta-1 389 glycine carriers + alpha-2C 322-325 Deletion carriers), that had no response. This pharmacogenetic approach therefore defines a target population for Gencaro that has a potentially enhanced response, as well as a small subpopulation that may not benefit from therapy; the genetic identification of such "outliers" in drug response is a major goal of pharmacogenetics.

Stuart Connolly, M.D., of McMaster University, an electrophysiologist-cardiologist, commented: "I believe that beta-blockers have only modest effects on prevention of serious ventricular arrhythmias, but in the Aleong et al study, patients with the higher activity beta-1 receptor genetic variant (389 arginine homozygous) had a significant (by 74%, p = 0.00005) and genotype specific reduction in the risk of ventricular tachycardia or fibrillation. This suggests that bucindolol may have clinically important anti-ventricular arrhythmic effects in the roughly 50% of patients who have the beta-1 389 arginine homozygous genotype, and I believe that further study of bucindolol in additional clinical trials is warranted."

Will Sauer, M.D., from the University of Colorado Anschutz Medical Campus, an electrophysiologist-cardiologist and a co-author on the paper, said: "While the use of beta-blockers as a class of drugs for prevention of ventricular arrhythmias is not well studied, it is commonly thought that any beta-blocker is potentially helpful for any at-risk patient. However, the research presented in our Circulation AEP paper shows that patients with the beta-1 389 arginine homozygous adrenergic receptor polymorphism experienced a 74% reduction in VT/VF events with the beta-blocker/sympatholytic agent bucindolol. I believe that these findings have important implications for the personalized treatment of patients at risk for arrhythmias. In the future, physicians may look at a patient's genotype prior to the initiation of a particular beta-blocker or other anti-arrhythmic. I believe that this is particularly important in the prevention of lethal arrhythmias like VT or VF, where the current practice of assuming that any beta-blocker may work could be harmful; for example, if the prescribed beta blocker is not efficacious or if a more efficacious beta-blocker for that patient is available."

Michael Bristow, M.D., Ph.D., Cardiologist/clinical pharmacologist and senior author on the paper, CEO of ARCA, also commented: "This 74% reduction in VT-VF in the beta-1 389 Arg/Arg subpopulation suggests that Gencaro warrants further study, such as in heart failure/reduced left ventricular ejection fraction patients at risk for ventricular arrhythmias, who have implanted cardioverter-defibrillators that are having appropriate firing. This could constitute another indication for Gencaro beyond those of atrial fibrillation prevention and heart failure."

Ventricular tachycardia and ventricular fibrillation are serious, potentially life-threatening arrhythmias, and the most common cause of sudden cardiac arrest.

ARCA has been granted patents in the U.S., Europe, and other jurisdictions for methods of identifying and treating patients with the beta-1 389 arginine homozygous genotype. The Company plans to conduct a Phase 3 clinical trial to evaluate Gencaro as a potential treatment for the prevention of AF in patients with this genotype, including measuring VT/VF data as a secondary endpoint, subject to receiving the necessary funding.

About ARCA biopharma

ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases. The Company's lead product candidate, Gencaro(TM) (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted atrial fibrillation prevention treatment. ARCA has a collaboration with the Laboratory Corporation of America (LabCorp), under which LabCorp has developed a companion genetic test for Gencaro. For more information, please visit www.arcabiopharma.com .

Safe Harbor Statement

This press release and the associated presentation may contain "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the ability of genetic variations to predict individual patient response to Gencaro, Gencaro's potential to treat atrial fibrillation, Gencaro's potential to treat ventricular tachycardia or ventricular fibrillation, and the potential for Gencaro to be the first genetically-targeted atrial fibrillation prevention treatment. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: the Company's financial resources and whether they will be sufficient to meet the Company's business objectives and operational requirements; results of earlier clinical trials may not be confirmed in future trials, the protection and market exclusivity provided by the Company's intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA's filings with the SEC, including without limitation the Company's annual report on Form 10-K for the year ended December 31, 2011 and subsequent filings. The Company disclaims any intent or obligation to update these forward-looking statements.

SOURCE: ARCA biopharma, Inc.


       
       ARCA biopharma, Inc.
       Christopher D. Ozeroff, 720-940-2100
       Senior Vice President and General Counsel
       



Copyright Business Wire 2013  

Jan. 29, 2013, 5:00 p.m. EST
New Adaptive Phase 3 Trial Planned for Gencaro(TM) in Atrial Fibrillation

BROOMFIELD, Colo., Jan 29, 2013 (BUSINESS WIRE) -- ARCA biopharma, Inc. ABIO -24.68% , a biopharmaceutical company developing genetically-targeted therapies for atrial fibrillation, heart failure and other cardiovascular diseases, today provided an update on a proposed, genetically-targeted clinical trial in atrial fibrillation ("AF") of the Company's lead developmental drug, Gencaro (bucindolol hydrochloride). The Company also announced that Medtronic, Inc., a leader in medical technologies to improve the treatment of chronic diseases, including cardiac rhythm disorders, has signed a non-binding Letter of Intent to collaborate on the initial, Phase 2B portion of the proposed trial.

The Proposed GENETIC-AF Phase 3 Adaptive Design Clinical Trial

The trial, known as GENETIC-AF, is projected to be a 620-patient, Phase 3 study comparing Gencaro to metoprolol CR/XL for prevention of AF in patients with heart failure and left ventricular dysfunction ("HFREF"). The Trial is planned to be genetically enriched by enrolling only those patients who possess the cardiac beta-1 adrenergic receptor genotype 389 arginine homozygous, which in the Beta Blocker Evaluation of Survival Trial ("BEST") was associated with an enhanced response to Gencaro in preventing atrial fibrillation. The Company estimates that this genotype is present in about 50% of the U.S. population. The primary endpoint of GENETIC-AF is planned to be the combination endpoint of recurrent symptomatic AF and all-cause mortality, over 24 weeks post electrical cardioversion for persistent AF. Commencement of the GENETIC-AF is conditional on receipt of the necessary funding, which ARCA intends to secure through equity financing or a strategic partnership.

ARCA has created an adaptive design for GENETIC-AF, under which the Company plans to initiate a Phase 2B study in approximately 200 HFREF patients. Depending on the results of the Phase 2B portion, the trial could then be expanded to a Phase 3 study by enrolling an estimated additional 420 patients. A secondary endpoint of the proposed Phase 2B portion of the trial will be AF burden, defined as a patient's actual time in AF, regardless of symptoms. Under the Company's proposed design, all 200 patients in the Phase 2B portion of the trial will have AF burden measured by continuous monitoring, either by previously implanted cardiac resynchronization or defibrillation devices, or newly or previously inserted implantable loop recorders. At the end of enrollment of the first 200 patients, the primary endpoint of recurrent symptomatic AF and all-cause mortality, and the secondary endpoint of AF burden will be evaluated by the trial's Data and Safety Monitoring Board for evidence of an efficacy signal. If a sufficient efficacy signal is detected and acceptable safety is observed, the trial would then proceed to the Phase 3 portion and full enrollment.

ARCA believes that Gencaro has potential as a treatment for AF, based on placebo-controlled data from the Phase 3 heart failure BEST study. A retrospective analysis of data from the BEST Trial shows that patients with the genotype that ARCA plans to enroll in GENETIC-AF had a 74% reduction in the risk of AF compared to placebo (p = 0.0003). These same patients experienced a 38% reduction in the risk of all cause mortality (p < 0.05) and statistically significant improvements on other major clinical efficacy endpoints.

AF is considered an epidemic cardiovascular disease with an estimated prevalence of at least 2.7 million Americans in 2010. In HFREF patients, the approved therapies for the treatment or prevention of AF have disadvantages, such as toxic or cardiovascular adverse effects, and most of the approved drugs are contra-indicated or have warnings in their prescribing information. ARCA believes there is an unmet medical need for new AF treatments that are safe and more effective in the HFREF population at risk for AF.

ARCA has received guidance from the Food and Drug administration ("FDA") regarding a Phase 3 clinical study comparing Gencaro to metoprolol for the prevention of AF in approximately 600 HFREF patients, with a design similar to GENETIC-AF, but without an adaptive feature. Based on this FDA guidance, the Company believes that a successful Phase 3 clinical study similar to GENETIC-AF, with a p-value of less than 0.01, could be sufficient evidence of efficacy upon which to base a New Drug Application ("NDA") for the approval of Gencaro for an AF indication in HFREF patients. ARCA plans to obtain further guidance from the FDA, which may affect the trial's design.

The proposed collaboration with Medtronic involves a substudy of the Phase 2B portion of GENETIC-AF that will measure the AF burden data by means of the continuous monitoring devices. Under the proposed collaboration, Medtronic would provide support associated with the AF burden substudy and with collection and analysis of the substudy data.

Dr. Michael Bristow, MD, PhD., President and Chief Executive Officer of ARCA, said, "We at ARCA are excited about the new adaptive design for GENETIC-AF and the potential to use AF burden measured by previously implanted devices as well as by newly inserted implantable loop recorders, which we believe represent the next generation of diagnosis and treatment options for patients at risk for AF. AF is a serious disorder that increases the risk of stroke and mortality, and in HFREF patients often heralds the worsening of heart failure. There is a need for new treatment options, particularly for patients with HFREF. The GENETIC-AF trial has the potential to result in an approvable new therapy that is safe and effective for HFREF patients at high risk for AF. We believe that the use of continuous monitoring devices including implantable loop recorders to monitor AF burden in the Phase 2B substudy will result in many more clinically-relevant events, which will potentially increase the power and usefulness of the data. We believe that AF burden used in conjunction with drug therapy will become an increasingly important tool in the diagnosis and treatment of AF."

About ARCA biopharma

ARCA biopharma is dedicated to developing genetically-targeted therapies for cardiovascular diseases. The Company's lead product candidate, Gencaro(TM) (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for atrial fibrillation. ARCA has identified common genetic variations that it believes predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted atrial fibrillation prevention treatment. ARCA has a collaboration with the Laboratory Corporation of America (LabCorp), under which LabCorp has developed a companion genetic test for Gencaro. For more information please visit www.arcabiopharma.com .

Safe Harbor Statement

This press release and the associated presentation may contain "forward-looking statements" for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements regarding the ability of likelihood of completing a definitive agreement with Medtronic for support of the planned trial, genetic variations to predict individual patient response to Gencaro, Gencaro's potential to treat atrial fibrillation, future treatment options for patients with atrial fibrillation, the number of events recorded by implantable loop recorders, the role of AF burden in diagnosis and treatment of atrial fibrillation and the potential for Gencaro to be the first genetically-targeted atrial fibrillation prevention treatment. Such statements are based on management's current expectations and involve risks and uncertainties. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including, without limitation, the risks and uncertainties associated with: the Company's financial resources and whether they will be sufficient to meet the Company's business objectives and operational requirements; results of earlier clinical trials may not be confirmed in future trials, the protection and market exclusivity provided by the Company's intellectual property; risks related to the drug discovery and the regulatory approval process; and, the impact of competitive products and technological changes. These and other factors are identified and described in more detail in ARCA's filings with the SEC, including without limitation the Company's annual report on Form 10-K for the year ended December 31, 2011 and subsequent filings. The Company disclaims any intent or obligation to update these forward-looking statements.

http://cts.businesswire.com/ct/...06796r1&sid=cmtx4&distro=nx

SOURCE: ARCA biopharma, Inc.


       
       ARCA biopharma, Inc.
       Christopher D. Ozeroff, 720-940-2100
       Senior Vice President and General Counsel
       



Copyright Business Wire 2013  

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