A Colorado-based biopharmaceutical company, Arca Biopharma (NASDAQ:ABIO), has a genetically-targeted drug, Gencaro (bucindolol hydrochloride), for Atrial fibrillation (AF) in patients with heart failure (HF). The drug offers a personalized medicine approach for the treatment of AF in HF, treating only individuals with certain genetic characteristics. This approach enables the selection of individuals who would most probably respond to the drug through excluding the expected non-responders, thus reducing a statistically failed trial outcome, in addition to decreasing clinical trial and healthcare costs.
Gencaro (bucindolol hydrochloride) is a pharmacologically unique beta-blocker and mild vasodilator aimed at preventing atrial fibrillation in patients with heart failure. The drug is created based on Arca's identification of common genetic variations in the cardiovascular system that it believes predict individual patient response to Gencaro, which will have the potential to be the first genetically-targeted AF prevention treatment. LabCorp and Arca have developed a companion diagnostic test for Gencaro to identify patient genotypes based on these genetic variations of the beta-1 cardiac receptor. LabCorp will provide the patient genetic testing for Arca's GENETIC-AF clinical trial of Gencaro, which is expected to begin enrolling patient at any time now.
By early December 2013, Laboratory Corporation of America (LabCorp) submitted an Investigational Device Exemption (IDE) application to the FDA for the companion diagnostic test for Gencaro so it could be used in the GENETIC-AF clinical trial.
Yesterday, the FDA approved the companion diagnostic test. Arca can and will soon initiate GENETIC-AF - a Phase 2B/3 multi-center, randomized, double-blind clinical trial comparing Gencaro with metoprolol CR/XL for prevention of AF in AF patients with heart failure and reduced left ventricular ejection fraction ("HFREF"). Previously conducted Phase 3 heart failure trial involving Gencaro in 2,708 HF patients suggest the drug may have a potentially significant effect in reducing and/or preventing AF.
Collaborating with Medtronic, Inc. on a Phase 2B portion of GENETIC-AF.
Under the collaboration with Medtronic, Arca will 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.
Our Word: It is a fact that the cardiology clinic is in dire need for more effective specific therapeutics, especially for atrial fibrillation and heart failure - both are chronic debilitating life-threatening diseases that have yet to be perfectly controlled. Atrial fibrillation is the most common heart rhythm disorder. Although it might be symptomless, it is often associated palpitation, chest pain and congestive heart failure. Atrial fibrillation may occur in episodes lasting from minutes to days ("paroxysmal"), or be permanent. It is said that the risk of stroke is increased five-fold in individuals with atrial fibrillation.
As mentioned above, a successful outcome of Arca's drug Gencaro will make it the first genetically-targeted AF prevention treatment.
Several studies have been published about bucindolol hydrochloride (Gencaro) demonstrating promising results. You can read these studies by clicking, or copying and pasting the following links: here, here, here.
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