$CAPR: Capricor Therapeutics: CAP-1002 demonstrate
Post# of 22755
Posted On: 06/16/2016 10:45:08 AM
$CAPR: Capricor Therapeutics: CAP-1002 demonstrates durable efficacy signal over 12 months in patients with advanced heart failure
Co announced positive preliminary 12-month data from its DYNAMIC (Dilated cardiomYopathy iNtervention with Allogeneic MyocardIally-regenerative Cells) clinical trial, which evaluated CAP-1002 in patients with advanced heart failure. CAP-1002 is Capricor's investigational allogeneic cardiosphere-derived cell (CDC) therapy.
For the 12 patients available for follow-up at one year, improvements from baseline in key cardiac function and dimensional indices were directionally maintained. Importantly, the change in median left ventricular ejection fraction from baseline to 12 months maintained its level of statistical-significance at six months (p=0.02 at both timepoints) and, on an absolute basis, continued to improve from six to 12 months. Of the five NYHA Class III subjects who received the highest dose of CAP-1002, two subjects improved by two Classes (to Class I) and three improved by one Class (to Class II) at six months. At 12 months, three of these five subjects were assessed as Class I and two as Class II, demonstrating further improvement and indicating durability of the benefit of CAP-1002 on heart failure status for as long as 12 months following administration. This 75 million cell dose is currently being evaluated in Capricor's HOPE-Duchenne clinical trial in boys with Duchenne muscular dystrophy (DMD)-associated cardiomyopathy."Furthermore, the safety record of the triple-coronary infusion procedure used in DYNAMIC is supportive of the design of our randomized, 24-patient HOPE-Duchenne clinical trial, for which we expect top line data in the first quarter of 2017."
Co announced positive preliminary 12-month data from its DYNAMIC (Dilated cardiomYopathy iNtervention with Allogeneic MyocardIally-regenerative Cells) clinical trial, which evaluated CAP-1002 in patients with advanced heart failure. CAP-1002 is Capricor's investigational allogeneic cardiosphere-derived cell (CDC) therapy.
For the 12 patients available for follow-up at one year, improvements from baseline in key cardiac function and dimensional indices were directionally maintained. Importantly, the change in median left ventricular ejection fraction from baseline to 12 months maintained its level of statistical-significance at six months (p=0.02 at both timepoints) and, on an absolute basis, continued to improve from six to 12 months. Of the five NYHA Class III subjects who received the highest dose of CAP-1002, two subjects improved by two Classes (to Class I) and three improved by one Class (to Class II) at six months. At 12 months, three of these five subjects were assessed as Class I and two as Class II, demonstrating further improvement and indicating durability of the benefit of CAP-1002 on heart failure status for as long as 12 months following administration. This 75 million cell dose is currently being evaluated in Capricor's HOPE-Duchenne clinical trial in boys with Duchenne muscular dystrophy (DMD)-associated cardiomyopathy."Furthermore, the safety record of the triple-coronary infusion procedure used in DYNAMIC is supportive of the design of our randomized, 24-patient HOPE-Duchenne clinical trial, for which we expect top line data in the first quarter of 2017."
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