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ARCA biopharma, Inc. (ABIO)

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Last Post: 4/17/2014 6:04:17 PM - Followers: 92 - Board type: Free - Posts Today: 0

 

Company Profile
 


Corporate Profile
ARCA biopharma, Inc. is a Colorado-based biopharmaceutical company developing genetically-targeted therapies for cardiovascular diseases.
ARCA was founded on the belief that a personalized medicine approach to drug development, tailoring medical treatment to the individual genetic characteristics of each patient, can enable more effective therapies, improve patient outcomes and reduce healthcare costs. ARCA’s lead development program is intended to be a direct implementation of those ideas. 
The Company's lead product candidate, GencaroTM (bucindolol hydrochloride), is an investigational, pharmacologically unique beta-blocker and mild vasodilator being developed for the prevention of atrial fibrillation in patients with heart failure. ARCA has identified common genetic variations in the cardiovascular system that it believes interact with Gencaro’s pharmacology and may predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted atrial fibrillation prevention treatment.

We are planning to initiate GENETIC-AF, a Phase 2B/3 clinical study of Gencaro in AF patients with heart failure and reduced left ventricular ejection fraction ("HFREF"). We believe AF is an attractive indication for Gencaro because data from BEST, the previously conducted Phase 3 heart failure trial involving Gencaro in 2,708 HF patients, suggest Gencaro may have a potentially significant effect in reducing and/or preventing AF. Based on the BEST trial, we believe Gencaro's prevention of AF in HF patients is pharmacogenetically regulated, similar to the effects on HF clinical endpoints.
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. The Company now anticipates that patient enrollment in GENETIC-AF will begin in the first quarter of 2014. The Company is collaborating with Medtronic, Inc. on the Phase 2B portion of GENETIC-AF.

Dr. Bristow Arca's President/Ceo was the founder of Myogen, and in 2006 Gilead Sciences Buys Myogen for $2.5 Billion.

Source: http://www.nytimes.com/2006/10/03/business/03drugs.html?_r=0





ARCA biopharma Provides Business Update:
 

Current: ARCA and Medtronic, Inc. are Collaborating on Phase 2B Portion of GENETIC-AF

Pipeline: GENETIC-AF Trial Evaluating Gencaro™ as Potential Treatment for Atrial Fibrillation Planned to Begin Patient Enrollment in Q1 2014


***ARCA has identified common genetic variations that it believes may predict individual patient response to Gencaro, giving it the potential to be the first genetically-targeted AF prevention treatment. AF is considered an epidemic cardiovascular disease with an estimated prevalence of at least 2.7 million Americans in 2010.


***Now have the resources to advance Gencaro into Phase 2B clinical evaluation


***In June, the Company completed an equity offering, raising net proceeds of approximately $18 million. As of June 30, 2013, the Company had approximately $20.4 million in cash and cash equivalents.


***ARCA and Medtronic, Inc. (MDT), a leader in medical technologies to improve the treatment of chronic diseases, including cardiac rhythm disorders, have entered into a collaboration agreement for the Phase 2B portion of GENETIC-AF, the Company’s Phase 2B/3 trial evaluating Gencaroas a potential treatment for AF.

 

Upcoming GENETIC-AF Trial Implementation Milestones

    -     GENETIC-AF Implementation Team Additions     July 2013
    -     GENETIC-AF Steering Committee Formalization     July 2013
    -     GENETIC-AF Data Safety Monitoring Board Formalization     Aug 2013
    -     Gencaro AF Investigational New Drug (IND) Application Submission     Q3 2013
    -     GENETIC-AF Clinical Research Organization Selection     Q3/Q4 2013
    -     GENETIC-AF Patient Enrollment Initiation     Q1 2014


***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. The Company now anticipates that patient enrollment in GENETIC-AF will begin in the first quarter of 2014.

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





IMPORTANT:

 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'S Gencaro is forcasting to take-ver Metoprolol's market consisting of 1+ billion


source: http://assets.aarp.org/www.aarp.org_/articles/bulletin/interactive/powerof50/oct09/





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™.











http://www.nuvelo.com/assets/File/ACC_2012_Gencaro_AF_PNE_poster-_3-20-12.pdf
















PostSubject
#868  Sticky Note ABIO~ has giant partners~~ NEW DD WITH LINK ~ Blue ~ 07/24/13 07:09:28 PM
#1374   Once they announce that they have 200 people baller on a budget 04/17/14 06:04:17 PM
#1373   Was waiting for trial related news but surprised allspice 04/17/14 10:09:02 AM
#1372   WESTMINSTER, Colo.--(BUSINESS WIRE)-- harmsen 04/17/14 09:26:02 AM
#1371   News!!!!!! harmsen 04/17/14 09:24:45 AM
#1370   Beautiful day we could see 1.33 tomorrow but baller on a budget 04/15/14 03:26:00 PM
#1369   Pps got close in the afternoon. Yes millman 04/14/14 09:12:12 PM
#1368   I am a cheap skate and 1.54 looked baller on a budget 04/14/14 06:39:59 PM
#1367   Ya millman, she is looking good 1.46 to baller on a budget 04/14/14 02:02:01 PM
#1366   B.O.B, The way this is correcting the answer is millman 04/12/14 06:41:41 PM
#1365   Millman, you looking at getting in under the baller on a budget 04/12/14 02:29:23 PM
#1364   ABIO caught up with a lot of other millman 04/11/14 07:54:01 PM
#1363   Wow, A lot of great deals popping up baller on a budget 04/11/14 04:40:08 PM
#1362   Yeah not bad - considering. millman 04/11/14 08:01:38 AM
#1361   With the raping of the biotech sector today baller on a budget 04/10/14 04:45:35 PM
#1360   HOD countdown in 3...2....... Biggeoff 04/02/14 10:29:58 AM
#1359   ABIO news. http://clinicaltrials.gov/ct2/show/NCT01970501?term=ARCA&rank=1 JBD24 03/29/14 04:25:14 PM
#1358   Waiting to see some progress made with the millman 03/22/14 09:40:28 AM
#1357   how much more please ? sam1807 03/21/14 01:57:42 PM
#1356   Today's 10k indicates the number is a little millman 03/20/14 08:36:40 PM
#1355   remember float only 11 Millions, adding all i the_little_farmer 03/19/14 11:34:32 AM
#1354   ARCA biopharma CEO Michael R. Bristow to Be BollixMeArse 03/19/14 09:28:19 AM
#1353   $ABIO those holding long have already done DD, JBD24 03/19/14 01:13:08 AM
#1352   Very good close today Marvy 03/18/14 04:35:02 PM
#1351   http://www.thestreet.com/story/12527111/1/small-cap-biotech-on-the-verge-of-a-breakout-abio.html?puc the_little_farmer 03/17/14 10:31:01 AM
#1350   $ABIO on the Verge of a Breakout, Be the_little_farmer 03/17/14 10:29:26 AM
#1349   $ABIO date approaches, be sure of it, that the_little_farmer 03/17/14 10:28:41 AM
#1348   Pps is still perking! millman 03/17/14 10:25:31 AM
#1347   $ABIO added 3500 more $ABIO on this dip, the_little_farmer 03/14/14 12:24:17 PM
#1346   I think so, been watching it for a Marvy 03/14/14 11:36:39 AM
#1345   80 % buy I believe 03/14/14 10:05:35 AM
#1344   So far not in the cards today. millman 03/13/14 12:50:09 PM
#1343   Yes indeed... 500K shares traded in 1st BHawksFan77 03/13/14 09:32:54 AM
#1342   LOL they are going to burn their winds, the_little_farmer 03/13/14 09:26:57 AM
#1341   Per Finra 1.2M shorted yesterday alone... BHawksFan77 03/13/14 09:17:08 AM
#1340   See why $ABIO is going to EXPLODE! the_little_farmer 03/13/14 08:53:28 AM
#1339   BE really attentive of this little pic i the_little_farmer 03/13/14 08:51:24 AM
#1338   Hi subs. Nice start! Should be millman 03/13/14 07:57:46 AM
#1337   Currently pre trading @ 2.35. Lets continue this subslover 03/13/14 07:41:47 AM
#1336   Thanks. I've been holding for some time, this ~DoughBoy~ 03/12/14 11:43:58 PM
#1335   Oh yes bud, hope you have your safety the_little_farmer 03/12/14 11:08:08 PM
#1334   Great day for ABIO. Looking forward to much more. ~DoughBoy~ 03/12/14 10:57:13 PM
#1333   Good after market trades. Gapper in the morning I believe 03/12/14 10:13:19 PM
#1332   Good looking chart! I believe 03/12/14 05:45:06 PM
#1331   Pps starting to perk!!! millman 03/12/14 05:26:47 PM
#1330   Very nice! Thanks for posting the story. subslover 03/12/14 04:09:51 PM
#1329   $ABIO here is the chart from the article the_little_farmer 03/12/14 03:22:31 PM
#1328   I bought more shares today. I have millman 03/05/14 05:16:38 PM
#1327   Purpose of Current Study: This study is being breezy1 03/05/14 10:50:32 AM
#1326   The Trial number for ARCA is NCT01970501 breezy1 03/05/14 10:43:35 AM
#1325   Have been in, but currently out. Citrati 03/01/14 06:23:12 PM
PostSubject