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ARCA biopharma, Inc. (ABIO)

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Last Post: 4/5/2018 10:14:56 AM - Followers: 99 - 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: Current Report Filing (8-k) 04/23/2018 04:12:30 PM
ABIO News: ARCA biopharma and Medtronic Extend Gencaro Clinical Trial Collaboration Agreement 04/23/2018 08:30:00 AM
ABIO News: Additional Proxy Soliciting Materials (definitive) (defa14a) 04/18/2018 12:07:33 PM
ABIO News: Proxy Statement (definitive) (def 14a) 04/18/2018 12:02:58 PM
ABIO News: Current Report Filing (8-k) 04/16/2018 05:17:33 PM
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#1938   Nice bounce looks great so far. DAD2 04/05/18 10:14:56 AM
#1937   Schedule 13D out, maybe someone smarter than me stoprun 03/05/18 05:20:14 PM
#1936   I'm here 25% is 25% . simmons420 03/05/18 06:27:26 AM
#1935   Could be a small 25% run this coming DAD2 03/04/18 07:51:56 PM
#1934   What news???? stoprun 03/02/18 10:06:31 AM
#1933   News! Kylef 03/02/18 09:04:02 AM
#1932   Most of insiders sold their shares. What happened? Agserina 03/01/18 09:04:16 PM
#1931   MM's (Market Manipulators) having a field day with stoprun 03/01/18 10:41:40 AM
#1930   What's with all the selling of shares here stoprun 02/28/18 07:47:29 PM
#1929   Thank you 867moneytime 02/28/18 02:16:55 PM
#1928   Nice when was that its showing the 52 DAD2 02/28/18 12:38:23 PM
#1927   Resistance for now seem's to be .90 cents, stoprun 02/28/18 12:10:28 PM
#1926   next resistance 1.00 then will fly to fill gap nokomis 02/28/18 10:43:22 AM
#1925   Thanks for the heads up pal. Best of 867moneytime 02/28/18 10:30:45 AM
#1924   Nice, there's room for pullback in there. It Migs123 02/28/18 10:30:17 AM
#1923   My buy is in at .24 for 120k 867moneytime 02/28/18 10:26:43 AM
#1922   Nice bounce could top $1 today. DAD2 02/28/18 10:25:03 AM
#1921   Thank you. Will do. 867moneytime 02/28/18 10:25:01 AM
#1920   I'd like to have your problem....take look at bpmx Migs123 02/28/18 10:24:48 AM
#1919   Heheheheh in at .51 yesterday morning. Only problem 867moneytime 02/28/18 10:21:27 AM
#1918   Thank You! hope this continues on the way stoprun 02/28/18 09:52:05 AM
#1917   that's the MMs signalling one another that they nokomis 02/28/18 09:28:27 AM
#1916   * * $ABIO Video Chart 02-27-18 * * ClayTrader 02/27/18 04:57:57 PM
#1915   Who keeps buying 100 shares at a time, stoprun 02/27/18 02:00:19 PM
#1914   My. .45 looking gooddddd steez 02/27/18 11:37:30 AM
#1913   * * $ABIO Video Chart 02-26-18 * * ClayTrader 02/26/18 05:08:07 PM
#1912   A Gamble: Red or black...the result of the BollixMeArse 02/15/18 03:04:31 AM
#1911   * * $ABIO Video Chart 11-16-17 * * ClayTrader 11/16/17 05:18:02 PM
#1910   Nice moves here this morning on good news! Curt D 11/16/17 10:02:48 AM
#1909   Thank you. Taking a bow...heheheheh 867moneytime 08/10/17 02:10:18 PM
#1908   LMAO. nice post ScapeGoat 08/10/17 01:38:16 PM
#1907   Not to buy a pos scam. Now GFY 867moneytime 08/10/17 01:21:22 PM
#1906   I watched. What was I supposed to learn? marriedtoolong 08/10/17 10:44:02 AM
#1905   Very good news indeed, certainly when we know alexander77 08/10/17 07:05:06 AM
#1904   Fly time tomorrow at bell!! PR mid morning!! 867moneytime 08/09/17 10:52:10 PM
#1903   Looks like someone is leaking bad news on data. willlbone 07/31/17 10:31:25 AM
#1902   Says 51 shareholders. willlbone 07/27/17 01:12:55 PM
#1901   Might be about that time to put it wiredawg 12/20/16 01:01:33 PM
#1900   $3.47 ClearlyStocks 05/20/16 01:24:05 PM
#1899   $3.38 on watch for $4+ ClearlyStocks 05/20/16 01:20:15 PM
#1898   Heading back to dallorville TaperT2 01/14/16 12:36:48 AM
#1897   New 13G filer Franklin Resources 18% http://www.sec.gov/Archives/edgar/data/9076 RealGenius 01/08/16 01:11:48 PM
#1896   So glad I passed on this POS Pure_Greatness 11/24/15 05:35:34 PM
#1895   ABIO 6.16 [SMART MONEY] 11/24/15 10:53:08 AM
#1894   ABIO took a starter here.. BoilerRoom 11/24/15 10:07:18 AM
#1893   This is going to take off! Setting up Dreamboyz 11/23/15 03:20:57 PM
#1892   Id say the way things are going we TaperT2 09/25/15 04:56:21 PM
#1891   Thats just Great TaperT2 09/04/15 03:25:12 PM
#1890   1:7 split harmsen 09/04/15 01:21:28 AM
#1889   You can see the trend .... Lower lower TaperT2 07/22/15 01:40:41 PM
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