LOS ANGELES, Nov. 9, 2015 /PRNewswire/ -- Capricor Therapeutics, Inc. (NASDAQ: CAPR), a biotechnology company focused on the discovery, development and commercialization of first-in-class therapeutics, today announced positive six-month safety and adverse event data from its ongoing DYNAMIC (Dilated cardiomYopathy iNtervention with Allogeneic MyocardIally-regenerative Cells) clinical trial evaluating CAP-1002 in patients with advanced heart failure.  The data were highlighted in a poster presentation at the 2015 American Heart Association (AHA) Scientific Sessions taking place November 7-11, 2015 in Orlando, FL.  CAP-1002 is Capricor's lead investigational allogeneic, cardiosphere-derived cell (CDC) therapy.

Multi-vessel intracoronary infusion of CAP-1002 in subjects with dilated cardiomyopathy was shown to be safe in this study with no major adverse cardiac events reported at one month or at six months post-infusion. Though this trial was intended as an early safety study, the six-month data demonstrated encouraging and congruent preliminary efficacy signals in multiple parameters, including subjective well being, exercise capacity, ejection fraction and ventricular volumes.

Table 1

Parameter

Median

Baseline

(Range)

Median

Month 6

(Range)

Median

% Change

(Range)

p-value*

Ejection Fraction (%)

24

(17, 30)

28

(18, 41)

+14.3

(-20, 65)

0.02

LVESV (mL)**

169

(92, 384)

131

(79, 218)

-20.4

(-47, 35)

0.03

LVEDV (mL)**

208

(128, 509)

175

(109, 293)

-15.2

(-44, 37)

0.08

6 minute walk test (m)

375

(180, 525)

400

(225, 525)

0.0

(-13, 113)

0.68

VO2 Max (m/kg/min)

13.9

(4.4, 22.4)

13.7

(10.6, 28.5)

3.0

(-25, 141)

0.46

Minnesota Living with Heart Failure (MLHFQ)**

48

(7, 105)

18

(1, 69)

-38.1

(-98, 79)

0.01



Table 2





NYHA (Class)

n (%) Baseline

n (%) Month 6

p-value*


Class I**

0

(0)

2

(17)

0.006


Class II**

0

(0)

9

(75)



Class III**

14

(100)

1

(8)




* Based on t-tests or signed rank tests of null hypotheses of absolute change from baseline = 0. For NYHA, null hypothesis was probability of improvement = 0.5. All tests were two-sided and were post hoc.  Analyses were based only on subjects for whom complete data were available in time for the AHA presentation data cutoff. N = 13 or 14 at baseline, 11 or 12 at Month 6 (depending on parameter).

** Decreased values indicate improvement.

"I am absolutely delighted with the preliminary safety data and efficacy signals of the DYNAMIC trial in highly symptomatic patients with severe cardiac dysfunction. These data justify further investigation of the CDC cells in larger clinical trials of patients with advanced heart failure of multiple etiologies. Heart failure is a malignant disease and one of the greatest unmet needs in all of medicine" said Raj Makkar, M.D., Director, Interventional Cardiology and Cardiac Catheterization Laboratory, Cedars-Sinai Medical Center, and principal investigator of the trial.  Dr. Makkar added, "what is specifically encouraging in this data set beyond the safety is the concordance between the clinical improvement and the physiologic measurements of trends for improved ejection fraction and reverse remodeling. These data are based on a small cohort and need to be confirmed in larger trials, but we do know that advanced heart failure patients do not, in general, spontaneously improve."

Dr. Linda Marbán, Chief Executive Officer of Capricor, commented "these data from the DYNAMIC trial continue to support our prior published findings that CAP-1002 has great potential to improve the outcomes for patients with advanced heart failure. Currently, there are more than 6 million Americans suffering from this disorder. Capricor has programs in place for advanced heart failure in adults, as well as in the cardiomyopathy of Duchenne Muscular Dystrophy (DMD) in young men. The FDA has granted CAP-1002 orphan status for DMD cardiomyopathy and the company is planning to initiate the upcoming HOPE trial for this indication. We look forward to significant progress in our quest to provide a new class of therapeutics for a large spectrum of patients suffering with cardiac disease and to address the very large market opportunities."

Presentation details:

Title: Dilated cardiomYopathy iNtervention with Allogeneic MyocardIally-regenerative Cells (DYNAMIC): Six Month Safety and Exploratory Efficacy Results
Date & Time: Monday, November 9, 2015, from 5:30-6:45PM ET
Location: Poster Hall, A2, BS
Poster #: M 1041
Session ID: APS.06.02. Stem/Progenitor Cells II

About DYNAMIC
The Phase I DYNAMIC trial, also known as the "Dilated cardiomYopathy iNtervention with Allogeneic MyocardIally-regenerative Cells" trial, is evaluating CDCs (CAP-1002) in patients with advanced heart failure. The trial enrolled 14 patients with either ischemic or non-ischemic dilated cardiomyopathy with left ventricular ejection fraction (LVEF) of 35% or below and New York Heart Association (NYHA) Class III or Ambulatory Class IV heart failure. Suitable patients underwent sequential intracoronary infusion of CAP-1002 in up to three coronary territories.  The triple vessel infusion was designed to deliver cells to wide areas of myocardium since patients with advanced heart failure have significant fibrosis in all areas of the heart.  The primary safety endpoints were assessed at the one-month visit. Other safety and exploratory efficacy endpoints including ejection fraction, ventricular volumes and a six-minute walk test were evaluated at six months and will be evaluated at a 12-month follow-up. The Phase I trial is being funded in part through a grant of approximately $3 million from the National Institutes of Health (NIH).

Please visit ClinicalTrials.gov (NCT02293603) for more information regarding the ongoing DYNAMIC clinical trial.

About CAP-1002
CAP-1002, Capricor's lead product candidate, is a proprietary allogeneic adult stem cell therapy for the treatment of heart disease. The product is derived from donor heart tissue. The cells are expanded in the laboratory using a proprietary process and then introduced directly into a patient's heart via infusion into a coronary artery using standard cardiac catheterization techniques.

CAP-1002 is currently not an approved product and is strictly for investigational purposes.

About Capricor Therapeutics 
Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class therapeutics. The Company's lead programs target post myocardial infarction (heart attack), heart failure and Duchenne Muscular Dystrophy. The Company has two lead product candidates under investigation: CAP-1002, a cardiac cell therapy and Cenderitide, a natriuretic peptide receptor agonist. CAP-1002 is in development for the treatment of post myocardial infarction (heart attack), advanced heart failure and Duchenne muscular dystrophy associated cardiomyopathy. Cenderitide is in development for the outpatient treatment of heart failure as well as potential other indications. In addition, the Company is conducting research and development on its exosomes platform technology for cardiac diseases and other potential indications. For additional information visit www.capricor.com.

Cautionary Note Regarding Forward-Looking Statements 
Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor's product candidates; the conduct, size, timing and results of discovery efforts and clinical trials; plans regarding regulatory filings, future research and clinical trials; plans regarding current and future collaborative activities and the ownership of commercial rights; scope, duration, validity and enforceability of intellectual property rights; future royalty streams, and any other statements about Capricor's management team's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words "believes," "plans," "could," "anticipates," "expects," "estimates," "should," "target," "will," "would" and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor's business are set forth in Capricor's Annual Report on Form 10-K for the year ended December 31, 2014, as filed with the Securities and Exchange Commission on March 16, 2015, in its Registration Statement on Form S-3, as filed with the Securities and Exchange Commission on September 25, 2015, and in its Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, as filed with the Securities and Exchange Commission on August 14, 2015. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements.

For more information, please contact:

Corporate Contact
Capricor Therapeutics, Inc.
AJ Bergmann, Vice President of Finance 
+1-310-358-3200
abergmann@capricor.com  

Investor Relations:
Argot Partners 
Angeli Kolhatkar
+1-212-600-1902
angeli@argotpartners.com

 

To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/capricor-therapeutics-presents-positive-data-from-the-dynamic-clinical-trial-at-2015-american-heart-association-scientific-sessions-300174663.html

SOURCE Capricor Therapeutics, Inc.