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ARCA biopharma, Inc. (ABIO)

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Last Post: 5/26/2015 9:49:30 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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Option Chain for ABIO
ABIO News: Confidential Treatment Order (ct Order) 05/20/2015 11:30:13 AM
ABIO News: Prospectus Filed Pursuant to Rule 424(b)(4) (424b4) 05/12/2015 05:00:24 PM
ABIO News: Quarterly Report (10-q) 05/12/2015 04:44:35 PM
ABIO News: Confidential Treatment Order (ct Order) 04/22/2015 01:27:10 PM
ABIO News: Prospectus Filed Pursuant to Rule 424(b)(4) (424b4) 04/14/2015 05:31:02 PM
#1807   maybe tomorrow Updated 05/26/15 09:49:30 PM
#1806   going up! bullish divergence, and rsi at 40, raptormeat 05/26/15 01:15:46 AM
#1805   going up from 1$ as news on Monday. :-) NILDIP007 05/15/15 12:09:00 PM
#1804   Higher low higher high.I have been watching this ash111 04/21/15 11:31:59 AM
#1803   let's see if it get's above 1 dollar brancoo0 04/21/15 11:30:31 AM
#1802   Worth now 2+ per net assets+cash vs current cap. ash111 04/21/15 11:24:04 AM
#1801   what's your target here ?? brancoo0 04/21/15 11:13:57 AM
#1800   It should ash111 04/21/15 11:11:08 AM
#1799   could it be running ...?? brancoo0 04/21/15 10:59:19 AM
#1798   Thanks for your chart. ash111 04/14/15 10:53:14 AM
#1797   Why not reading recent posts? You will find ash111 04/14/15 10:32:34 AM
#1796   What do you base your opinion on? duderaja 04/14/15 09:53:07 AM
#1795   same old crap Johnnycash2013 04/14/15 09:37:15 AM
#1794   * * $ABIO Video Chart 04-13-15 * * ClayTrader 04/13/15 05:05:39 PM
#1793   true like most Biopharma's.the matket liking today's FDA ash111 04/13/15 04:16:39 PM
#1792   yep this traders prob.took profits. ash111 04/13/15 04:12:17 PM
#1791   They have no revenue at all. Just cash burning. kent3 04/13/15 04:11:56 PM
#1790   Ouch those last 5 minutes were ruff Johnnycash2013 04/13/15 04:10:09 PM
#1789   it's in Thousands.Check the 10k ash111 04/13/15 03:57:39 PM
#1788   Lol I retarded I read that as $15k. Johnnycash2013 04/13/15 03:56:13 PM
#1787   16m in cash vs 17m market cap.only ash111 04/13/15 03:53:37 PM
#1786   What's their monthly burn rate? Not a lot Johnnycash2013 04/13/15 03:52:30 PM
#1785   Market value $17,804,545 a/o Apr 10, 2015, vs: ash111 04/13/15 03:48:30 PM
#1784   What's mv? Johnnycash2013 04/13/15 03:43:37 PM
#1783   mid-term still low. ash111 04/13/15 03:39:32 PM
#1782   When do u expect to see $2? Johnnycash2013 04/13/15 03:28:26 PM
#1780   check my recent posts,per numbers this is going ash111 04/13/15 02:24:28 PM
#1779   I like that it filled the gap from Johnnycash2013 04/13/15 01:57:40 PM
#1778   $ABIO recent news/filings stocktrademan 04/13/15 01:44:38 PM
#1777   check the link from nasdaq calls/puts options.again ash111 04/13/15 01:39:31 PM
#1776   3/31/2015 shares shorted 960,293 check kent3 04/13/15 01:38:01 PM
#1775   Who told you that? You have some insider info?? Want2BMillionaire 04/13/15 01:35:18 PM
#1774   do you see options? ash111 04/13/15 01:34:32 PM
#1773   How is that possible? Johnnycash2013 04/13/15 01:31:53 PM
#1772   i have been told there are no options ash111 04/13/15 01:29:46 PM
#1771   Come on ABIO get to a NHD!!!!!! $$$$$$$$$$$$$$$$ Want2BMillionaire 04/13/15 11:41:30 AM
#1770   Cool! I am very excited about ATHX because Want2BMillionaire 04/13/15 11:10:12 AM
#1769   great.both are solid. will check it out the ash111 04/13/15 11:08:22 AM
#1768   Hello Ash! I do have ABIO, I didn't Want2BMillionaire 04/13/15 11:07:29 AM
#1767   you should have grabbed some.the market liking the ash111 04/13/15 10:34:04 AM
#1766   She should see 2+imo ash111 04/13/15 10:10:33 AM
#1765   Pre Market 1,12 + 36% harmsen 04/13/15 09:02:05 AM
#1764   Nice news!!!!!!! harmsen 04/13/15 09:00:54 AM
#1763   Really? I don't see this news on their website... TradinTom 04/05/15 07:22:59 PM
#1762   The news is on their website, thought they trinadad 04/02/15 01:40:53 PM
#1761   i'm thinking monday because of the holiday weekend. GraniteState 04/02/15 01:36:57 PM
#1760   I wonder why they haven't done a PR trinadad 04/02/15 11:54:55 AM
#1759   Thank you sutt!! Want2BMillionaire 04/01/15 06:50:57 PM
#1758 sutt 04/01/15 06:40:26 PM
#1757   Where did you see that?? Provide a link? Want2BMillionaire 04/01/15 06:23:16 PM