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ARCA biopharma, Inc. (ABIO)

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Last Post: 7/22/2015 1:40:41 PM - Followers: 108 - 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: ARCA biopharma to Present at the Rodman & Renshaw 17th Annual Global Investment Conference 08/26/2015 08:30:00 AM
ABIO News: Prospectus Filed Pursuant to Rule 424(b)(4) (424b4) 08/11/2015 04:42:34 PM
ABIO News: Quarterly Report (10-q) 08/11/2015 04:36:56 PM
ABIO News: Current Report Filing (8-k) 08/11/2015 04:18:02 PM
ABIO News: ARCA biopharma Announces Second Quarter 2015 Operating Results and Provides Update on Recent Accomplishments 08/11/2015 04:00:00 PM
#1889   You can see the trend .... Lower lower TaperT2 07/22/15 01:40:41 PM
#1888   look at volume before you embarrass yourself next time... Updated 07/16/15 11:57:50 PM
#1887   I guess those Financals that were loading TaperT2 07/16/15 03:02:52 PM
#1886   What a F..k! Damn bought 20k shares and Patrickwan1 07/16/15 11:30:41 AM
#1885   Morning AF. my understanding is that any FDA hardtogetnewalias 07/14/15 06:40:07 AM
#1884   how come some here thinks news about clinical hardtogetnewalias 07/14/15 06:31:36 AM
#1883   ABIO 1.52 the 52 week high is 1.56 AugustaFriends 07/13/15 02:30:41 PM
#1882   Moving nicely for a monday... More to come? declaes 07/13/15 02:18:40 PM
#1881   $Abio. dont know about, there's some serous resistance oogle 07/13/15 12:03:12 PM
#1880   looking great here!! let's get to 1.65 by Tuesday AugustaFriends 07/13/15 11:05:38 AM
#1879   Im accumulating. DOGONE 07/12/15 10:14:23 AM
#1878   very possible ,better SS here than PBMD that balamidas 07/11/15 12:07:46 AM
#1877   $10 Target if good FDA news AugustaFriends 07/11/15 12:05:32 AM
#1876   $10 Target if good FDA news AugustaFriends 07/11/15 12:05:32 AM
#1875   Some financials are loading BIG as of late.. AugustaFriends 07/11/15 12:04:57 AM
#1874   easy balamidas 07/11/15 12:02:50 AM
#1873   Yes, I think 1.60's next week.. Look at AugustaFriends 07/10/15 11:59:46 PM
#1872   breakout here ~ balamidas 07/10/15 11:56:04 PM
#1871   Agree we need to get the latest numbers AugustaFriends 07/10/15 10:45:01 PM
#1870   This is going much higher, Golden Cross break AugustaFriends 07/10/15 10:44:41 PM
#1869   $ABIO Franklin Templeton reports 13.7% stake AugustaFriends 07/10/15 10:43:57 PM
#1868   Agree with that Target AugustaFriends 07/10/15 10:43:33 PM
#1867   $4 ... It has a long way to TaperT2 07/10/15 02:15:37 PM
#1866   $ABIO recent news/filings stocktrademan 07/10/15 01:21:23 PM
#1865   I like the 84 share purchase in AH hardtogetnewalias 07/10/15 05:37:25 AM
#1864   Price action has been looking mighty healthy on SPM555 07/09/15 11:40:12 AM
#1863   bro. that's just a bloggers opinion. no cold hardtogetnewalias 07/09/15 07:14:35 AM
#1862   many funds have added millions upon millions of hardtogetnewalias 07/08/15 03:22:01 AM
#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 >>> 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