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ARCA biopharma, Inc. (ABIO)

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Last Post: 7/7/2015 7:24:05 PM - Followers: 109 - 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: Securities Registration Statement (simplified Form) (s-3) 07/07/2015 04:40:47 PM
ABIO News: Statement of Beneficial Ownership (sc 13d) 06/29/2015 04:51:17 PM
ABIO News: Statement of Ownership (sc 13g) 06/25/2015 04:42:34 PM
ABIO News: Small Company Offering and Sale of Securities Without Registration (d) 06/25/2015 04:25:05 PM
ABIO News: Statement of Ownership (sc 13g) 06/25/2015 03:06:13 PM
News News Alert: Securities Registration Statement (simplified Form) (s-3) 07/07/2015 04:40:47 PM
PostSubject
#1861   yes, it is good... some idiot sold Updated 07/07/15 07:24:05 PM
#1860   nobody read the filings here? hardtogetnewalias 07/07/15 05:19:24 PM
#1859   Ok... hardtogetnewalias 07/07/15 02:13:38 AM
#1858   this >>> http://www.insidermonkey.com/blog/ra-capital-is-expecting-a-breakthroug balamidas 07/06/15 11:30:36 PM
#1857   yo I can't find anything about any clinical hardtogetnewalias 07/06/15 05:23:59 PM
#1856   :) it is. But we might need to hardtogetnewalias 07/06/15 03:38:54 PM
#1855   looks Up to me today balamidas 07/06/15 03:36:58 PM
#1854   Starting to think that the run from .7x hardtogetnewalias 07/06/15 01:06:13 PM
#1853   do we have a 5% spread today?? or hardtogetnewalias 07/06/15 09:43:08 AM
#1852   no news 2day. looks like it may drop hardtogetnewalias 07/06/15 09:22:20 AM
#1851   article was talking about a Cancer breakthrough drug ! balamidas 07/05/15 01:13:21 AM
#1850   whats coming here Armani 07/05/15 12:18:08 AM
#1849   Super! Thanx hardtogetnewalias 07/04/15 05:02:42 PM
#1848   i will check it bro ,thanks balamidas 07/04/15 04:56:52 PM
#1847   Just read that the results arent ecpected before 2016. hardtogetnewalias 07/04/15 04:54:58 PM
#1846   Ok. Thanks. That can pretty mich end up however hardtogetnewalias 07/04/15 04:40:13 PM
#1845   clinical trials results balamidas 07/04/15 04:37:38 PM
#1844   What news might we get? hardtogetnewalias 07/04/15 03:04:55 AM
#1843   Bought some of this TopPick 07/02/15 12:06:51 AM
#1842   with NEWS way higher ! looks like the balamidas 06/30/15 11:26:15 PM
#1841   Sounds about right. 1st key level @ 1.18 KingErik999 06/30/15 04:51:35 PM
#1840   major price breakout is ahead ,with the right balamidas 06/30/15 04:18:49 PM
#1839   You're right, thought it was gonna close at outnabout 06/30/15 04:16:18 PM
#1838   nice close today ,looks good for tomorrow balamidas 06/30/15 04:13:51 PM
#1837   ABIO, IMO,get past this 1.05 and we could outnabout 06/30/15 11:55:05 AM
#1836   Great read. Thanks. outnabout 06/30/15 09:20:15 AM
#1835   ABIO looks very appealing >>>> http://www.insidermonkey.com/blog/ra-capital-is-e balamidas 06/30/15 01:13:21 AM
#1834   Entered on Friday. Chart looks like it's outnabout 06/29/15 09:45:28 AM
#1833   the institutional investors has seen some solid data balamidas 06/29/15 12:13:36 AM
#1832   this week could confirm the new uptrend balamidas 06/28/15 11:27:32 PM
#1831   I agree B.E for me is still over TaperT2 06/28/15 01:52:44 AM
#1830   ABIO has been trading for almost 10 days balamidas 06/27/15 11:55:07 PM
#1829   Yea gettin ready to run here been watchin tooincredible52 06/27/15 02:50:45 PM
#1828   ABIO is just starting its breakout ,we could balamidas 06/27/15 12:28:39 AM
#1824   on watch Armani 06/26/15 02:30:56 PM
#1823   it seems you are right.ABIO always has been ash111 06/26/15 11:44:30 AM
#1822   This breakout looks better than the last couple. SPM555 06/26/15 11:43:34 AM
#1821   If $1 will not hold again.god help this one. ash111 06/26/15 10:00:44 AM
#1820   nice. ash111 06/26/15 06:34:02 AM
#1819   Nice run AH 1,18! harmsen 06/26/15 01:22:12 AM
#1818   News out. $37 Million Private Placement ash111 06/17/15 09:18:39 AM
#1817   time pyramide3465 06/15/15 06:39:44 PM
#1816   I figured it was B.S. In future I'll BollixMeArse 06/08/15 03:43:33 AM
#1815   Sierra always blogs about secret meetings and buy outs. hardtogetnewalias 06/06/15 06:38:22 AM
#1814   The price action tells me that the fast DOGONE 06/05/15 11:24:06 AM
#1813   The problem here is that ABIO can't break ash111 06/05/15 09:42:44 AM
#1812   new to this stock. what news are u hardtogetnewalias 06/05/15 09:15:53 AM
#1811   a tip when Sierra writes anything. it bogus hardtogetnewalias 06/05/15 09:15:29 AM
#1810   Meeting With Pfizer - June 5th, 2015 ?? BollixMeArse 06/04/15 10:04:07 PM
#1809   ITS back to 1$ tom before the afternoon news!! NILDIP007 06/04/15 09:19:38 PM
PostSubject