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ARCA biopharma, Inc. (ABIO)

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Last Post: 9/19/2018 1:35:56 AM - Followers: 100 - 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: Proxy Statement (definitive) (def 14a) 09/20/2018 04:09:26 PM
ABIO News: Current Report Filing (8-k) 09/18/2018 04:12:50 PM
ABIO News: ARCA biopharma Submits Special Protocol Assessment Request to FDA for Gencaro Phase 3 Atrial Fibrillation Clinical Trial 09/18/2018 08:30:00 AM
ABIO News: Proxy Statement - Notice of Shareholders Meeting (preliminary) (pre 14a) 09/10/2018 05:19:16 PM
ABIO News: Current Report Filing (8-k) 08/09/2018 04:39:36 PM
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#2012   Combined with phase 3 results this may be Klinsmann 09/19/18 01:35:56 AM
#2011   MR CEO THE SHARE HOLDERS WANT TO THANK stock king 1 09/18/18 03:59:32 PM
#2010   Good morning Ranza. You can find it on Curt D 08/22/18 10:10:32 AM
#2009   Good morning?Where I can find or buy REAL Ranza 08/22/18 10:00:45 AM
#2008   i agree 0,50-0,56 toro bravo 08/16/18 09:13:28 AM
#2007   will be a strong buy if it holds DAD2 08/16/18 09:09:22 AM
#2006   Boom up today.Get ready,it going more than 1$ toro bravo 08/10/18 07:27:33 AM
#2005   After trading a High of $1.28 on July Necropolis 08/09/18 01:31:56 PM
#2004   We should get the Quarter 2 earnings report Monday. Curt D 08/03/18 10:42:15 AM
#2003   Next week more than 1,20.HOLD OR BUY HERE NOW toro bravo 08/03/18 09:13:26 AM
#2002   Definitely! ABIO $$$ Joeymc77 08/03/18 09:00:35 AM
#2001   you think we can be back at 1.20 taldhaliwal05 08/02/18 08:38:39 PM
#2000   Could be! Nice momentum this morning. Curt D 08/02/18 10:31:59 AM
#1999   Back to 1$ ??! Obelax 08/02/18 10:29:16 AM
#1998   82‘ looking good Obelax 08/02/18 09:59:09 AM
#1997   Nice buys going through this morning! Curt D 08/02/18 09:50:08 AM
#1996   Next red day Obelax 08/02/18 09:35:45 AM
#1995   Thank you very much! toro bravo 08/02/18 09:01:33 AM
#1994   Monday should be earnings report. Curt D 08/02/18 08:58:13 AM
#1993   When they take the results of the quarter?Someone? toro bravo 08/01/18 04:19:51 PM
#1992   How does this open with a gap up bryanmm 08/01/18 04:00:05 PM
#1991   Yesterday 25MVolumen today 1,5M total newbie fail push invest Obelax 08/01/18 01:35:00 PM
#1990   0,68-0,69 as we see today toro bravo 08/01/18 10:59:39 AM
#1989   Buy yesterday :-/ ... where is the support piont? Obelax 08/01/18 10:14:40 AM
#1988   I’m buying :) Joeymc77 08/01/18 10:06:19 AM
#1987   whats going on here ? taldhaliwal05 08/01/18 09:51:44 AM
#1986   * * $ABIO Video Chart 07-31-18 * * ClayTrader 07/31/18 04:58:27 PM
#1985   Let’s go Abio !! Close above $1 Joeymc77 07/31/18 02:48:18 PM
#1984   nice buyers here IMHO 66428 prints 3 times MTNBIRD 07/31/18 01:48:00 PM
#1983   Yes 76 was a good entry point :-) Obelax 07/31/18 01:08:40 PM
#1982   Looking good so far! Curt D 07/31/18 01:04:29 PM
#1981   wmih check it out ajrum 07/31/18 12:20:34 PM
#1980   Up we go again .. ! 1.30 close Joeymc77 07/31/18 12:10:53 PM
#1979   Running of the Bulls around the corner? IMHO MTNBIRD 07/31/18 12:04:15 PM
#1978   It's looking to have bottomed and is bouncing Curt D 07/31/18 11:16:32 AM
#1977   Close 1,50?? Big red coming... Obelax 07/31/18 11:04:42 AM
#1976   Gap will fill at .817. Almost there! I'm Curt D 07/31/18 11:00:50 AM
#1975   we will close at 1.50 today taldhaliwal05 07/31/18 10:58:34 AM
#1974   Ouch... Obelax 07/31/18 10:56:51 AM
#1973   Feed me these cheap shares.. see you at Joeymc77 07/31/18 10:34:02 AM
#1972   Pos trial news yet pps going down micar 07/31/18 09:52:53 AM
#1971   ABIO screaming this morning. Curt D 07/31/18 09:39:37 AM
#1970   $30 are you serious, do you think it laplova 07/30/18 08:49:38 PM
#1969   * * $ABIO Video Chart 07-30-18 * * ClayTrader 07/30/18 05:38:32 PM
#1968   just buy and hold. Easy money here. aristotelisonassis 07/30/18 05:12:47 PM
#1967   Yes impressive list. Seems these days almost anything RLBTrader 07/30/18 04:58:45 PM
#1966   Read somewhere could be trading for $30 next Acheron1 07/30/18 04:26:51 PM
#1965   Nice volume spike at 3:30 could be the RLBTrader 07/30/18 04:13:59 PM
#1964   ABIO - Nice volume today. Tim Tim 07/30/18 10:55:37 AM
#1963   Headed up a small amount every week, no DAD2 07/30/18 10:52:54 AM
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