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ARCA biopharma, Inc. (ABIO)

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Last Post: 3/2/2015 6:36:49 PM - Followers: 101 - Board type: Free - Posts Today: 0


***These patients experienced a 74% (p = 0.0003) reduction in risk of AF versus no detectable reduction in patients who had alternative genotypes (beta1389 Gly carriers; 53% of the patients) who had received placebo. The Company believes this data supports the potential ability of Gencaro to prevent AF in patients who have the genotype the Company believes responds most favorably to Gencaro.


The Science:

GENETIC-AF Clinical Trial

GENETIC-AF is planned as a Phase 2B/3, multi-center, randomized, double-blind clinical trial comparing Gencaro to metoprolol CR/XL for prevention of AF in patients with heart failure and reduced left ventricular ejection fraction (HFREF). ARCA plans to enroll only patients with the genetic variant of the beta-1 cardiac receptor which the Company believes responds most favorably to Gencaro. GENETIC-AF has an adaptive design, under which the Company plans to initiate it as a Phase 2B study in approximately 200 patients and then, depending on the results of an interim analysis by the trial Data Safety Monitoring Board (DSMB), expand the trial to a Phase 3 study by enrolling an estimated additional 420 patients.

Under the collaboration with Medtronic, ARCA plans to conduct a substudy that will include continuous monitoring of the cardiac rhythms of all 200 patients enrolled during the Phase 2B portion of GENETIC-AF. Each patient will have heart rhythm monitoring via a Medtronic device, either a previously implanted cardiac resynchronization or defibrillation device, or a previously or newly inserted Reveal® loop recorder. The collaboration substudy will measure AF burden, defined as a patient’s actual time in AF regardless of symptoms. For the DSMB interim analysis, AF burden and the primary endpoint of the study, time to recurrence of symptomatic AF after electrical cardioversion, or death, will be reviewed by the DSMB to determine if there is sufficient potential for a statistically significant efficacy signal to be determined for all patients enrolled in the Phase 2B/3 study. 

 

Gencaro Data in Atrial Fibrillation

Clinical data analysis from a post-hoc review of patient forms from the from BEST trial, a Phase 3 trial in 2,708 patients with advanced heart failure, indicate that Gencaro may have a potentially enhanced and pharmacogenetically-influenced effect in reducing and preventing AF. In that trial, patients in the Gencaro arm had a reduction in the risk of new onset AF time to event compared to patients in the placebo arm of 41% (AF measured as an adverse event/serious adverse event or as detected on surveillance ECGs, time to event analysis, p = 0.0004). In a 1,040 patient DNA substudy of BEST, Gencaro exhibited potential pharmacogenetic enhancement and differentiation for AF prevention in patients with a specific genotype (beta1389 arginine homozygous (Arg/Arg) adrenergic receptor (AR); approximately 47% of the patients). These patients experienced a 74% (p = 0.0003) reduction in risk of AF versus no detectable reduction in patients who had alternative genotypes (beta1389 Gly carriers; 53% of the patients) who had received placebo. The Company believes this data supports the potential ability of Gencaro to prevent AF in patients who have the genotype the Company believes responds most favorably to Gencaro.

In prior placebo controlled trials of beta blockers in chronic HFREF, most studies comparing beta-blockers to placebo have detected a positive signal for prevention of AF, with an event rate reduction averaging approximately 27%, although AF had not been a pre-specified primary or secondary endpoint in these studies. Currently, no beta-blocker has been approved by the U.S. Food and Drug Administration for the prevention of
AF in heart failure patients.

Gencaro™ [Bucindolol Hydrochloride]
ARCA is currently developing Gencaro™ (tradename pending FDA approval) (bucindolol hydrochloride) for the prevention of atrial fibrillation and the treatment of chronic heart failure. Gencaro™ is a pharmacologically unique beta-blocker and mild vasodilator. Gencaro™ is considered part of the beta-blocker class because of its property of blocking beta-1 as well as beta-2 receptors in the heart, preventing these receptors from binding with other molecules that would otherwise activate the receptor. Because of its mild vasodilator effects, the Company believes Gencaro™ is well-tolerated in patients with advanced HF. ARCA has identified common genetic variations, or genetic markers, that it believes predict patient response to Gencaro™.

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ABIO News: Prospectus Filed Pursuant to Rule 424(b)(4) (424b4) 02/23/2015 05:10:10 PM
ABIO News: Current Report Filing (8-k) 02/23/2015 04:51:08 PM
ABIO News: Statement of Changes in Beneficial Ownership (4) 02/17/2015 06:22:31 PM
ABIO News: Statement of Changes in Beneficial Ownership (4) 02/17/2015 06:19:49 PM
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PostSubject
#1728   Man itake off for 18 mo. and come TaperT2 03/02/15 06:36:49 PM
#1727   Still watch this one regularly. Took a loss allspice 02/26/15 10:48:43 AM
#1726   nothing new yet? Updated 02/16/15 03:43:28 AM
#1725   any update about the US clinical study sites? Updated 02/05/15 03:20:22 AM
#1724   WESTMINSTER, Colo.--(BUSINESS WIRE) harmsen 02/04/15 08:44:42 AM
#1723   it seems they are waiting on some results Updated 02/01/15 09:31:31 AM
#1722   Anything development in the drugs advancements? fmd 01/23/15 03:39:31 PM
#1721   loading zone here ... brancoo0 01/23/15 09:45:12 AM
#1720   in today's vegas market, expect no explanation... Updated 01/21/15 08:47:08 PM
#1719   .7 the bottom? Bucknasty614 01/21/15 09:42:40 AM
#1718   Anything new or explanation of the plunge is fmd 01/20/15 08:26:50 PM
#1717   is there something in the pipeline here ?? brancoo0 01/13/15 04:49:22 PM
#1716   thank you, BOL to you too Updated 01/07/15 03:57:47 PM
#1715   Thanks. Grabbed some today. BOL Bucknasty614 01/07/15 03:50:08 PM
#1714   I have about 39k sbares at 1.15 and Updated 01/07/15 03:49:57 PM
#1713   let's hope Updated 01/07/15 03:44:37 PM
#1712   yes, we should hear some updates about Updated 01/07/15 03:44:07 PM
#1711   This is going to pop real soon get fmd 01/07/15 04:40:05 AM
#1710   Deadline on patience? Or just waiting forever? Bucknasty614 01/06/15 08:44:17 PM
#1709   patience Updated 01/06/15 08:42:57 PM
#1708   What's the deal here? Bucknasty614 01/06/15 05:50:07 PM
#1707   Making that noticeable cup and handle on the TradeSmart 12/30/14 06:09:29 AM
#1706   Support seems to be more at low .90's now. Optimystic 12/18/14 10:50:27 AM
#1705   .98 looks to be support here TradeSmart 12/16/14 01:23:56 PM
#1704   I was thinking the same thing. where do pauljack13 12/16/14 12:46:42 PM
#1703   Looking good today, $ABIO next leg up? TradeSmart 12/16/14 12:00:20 PM
#1702   Is that $1.14 at ask? GreenThumb Investor 12/16/14 11:23:34 AM
#1701   Anything new? fmd 12/15/14 10:06:06 PM
#1700   No AH trades yesterday, look >http://www.nasdaq.com/symbol/abio/after-hours .cha beerput 12/13/14 07:23:01 AM
#1699   If support holds at that .80 to .85 pauljack13 12/13/14 06:11:44 AM
#1698   After hour trading Optimystic 12/12/14 10:36:46 PM
#1697   Close 1,02 ? http://www.nasdaq.com/symbol/abio/time-sales beerput 12/12/14 07:07:25 PM
#1696   here are my 0,95, next shares i buy smul 12/12/14 03:50:16 PM
#1695   Happy Friday ABIOers GreenThumb Investor 12/12/14 09:08:47 AM
#1694   Lol do I hear a Phoenix? MrPoppaGeorgeo 12/11/14 08:42:14 PM
#1693   Good close GreenThumb Investor 12/11/14 03:59:41 PM
#1692   Next week 1,80!!!! harmsen 12/11/14 03:41:09 PM
#1691   Staying above $1 all day GreenThumb Investor 12/11/14 03:34:40 PM
#1690   i will load a few at 0,95, that's smul 12/11/14 01:36:12 PM
#1689   Ca caawwwww Vita Nova Stocks 12/11/14 12:47:33 PM
#1688   ABIO....Nice dip, loaded a few !!! Wallst_junkie 12/11/14 12:43:52 PM
#1687   ABIO...support set at 13's....could be go time!!! Wallst_junkie 12/11/14 11:44:34 AM
#1686   Big time bid just showed up, $30K @ swamprat2 12/11/14 11:44:26 AM
#1685   they will be cleared ...go abio brancoo0 12/11/14 11:32:12 AM
#1684   ABIO...Are we ever going to clear these 15's. :) Wallst_junkie 12/11/14 11:27:58 AM
#1683   What a "POP"!!! DD 12/11/14 11:07:27 AM
#1682   40% is awesome. Congrats, and I hope this BigGold 12/11/14 11:00:32 AM
#1681   Maybe 2$ EOW! GERMONEY 12/11/14 10:47:22 AM
#1680   Moving back up to daily highs! Go ABIO GreenThumb Investor 12/11/14 10:47:03 AM
#1679   maybe 1.40 eod ...go abio brancoo0 12/11/14 10:40:11 AM
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