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LONDON, UK / ACCESSWIRE / April 26, 2017 / Active Wall St. blog coverage looks at the headline from Capricor Therapeutics, Inc. (NASDAQ: CAPR) as the Company announced positive top-line results from a safety and exploratory efficacy analysis of six-month data from the randomized 12-month Phase I/II HOPE Clinical Trial of CAP-1002 (allogeneic cardiosphere-derived cells), an investigational candidate for the treatment of patients with Duchenne muscular dystrophy, or DMD. Register with us now for your free membership and blog access at: One of Capricor Therapeutics' competitors within the Biotechnology space, BioMarin Pharmaceutical Inc. (NASDAQ: BMRN), announced on April 20, 2017, that Jean-Jacques Bienaimé, the Company's Chairman and CEO, will host a conference call and webcast on Thursday, May 04, at 4:30 p.m. ET to discuss Q1 2017 financial results and provide a general business update. AWS will be initiating a research report on BioMarin Pharma in the coming days. Today, AWS is promoting its blog coverage on CAPR; touching on BMRN. Get all of our free blog coverage and more by clicking on the link below: The randomized HOPE (Halt cardiomyOPathy progression in Duchenne) clinical Trial was designed to evaluate the safety and exploratory efficacy of CAP-1002 in patients 12 years and older with DMD and who had cardiomyopathy, or heart disease, secondary to DMD as evidenced by scar in four or more left ventricular segments as detected by late gadolinium-enhancement MRI. Twenty-five patients were randomized to receive either a single dose of CAP-1002 or usual care. CAP-1002 was infused into each of the three main coronary arteries at a total dose of 75 million cells. Capricor stated that in exploratory efficacy analyses, statistically-significant improvements in systolic thickening of the inferior wall of the heart, and in the function of the middle and distal upper limb according to a PUL responder analysis, were observed in patients treated with CAP-1002 as compared to usual care control patients. Additionally, differences observed in several other cardiac and skeletal muscle measures, including cardiac scar were consistent with a treatment effect. CAP-1002 was generally safe and well-tolerated over the initial six-month follow-up period. Capricor has submitted a meeting request to the US Food and Drug Administration, or FDA, to discuss potential product registration strategies for CAP-1002 in the DMD indication. "These initial positive clinical results build upon a large body of preclinical data which illustrate CAP-1002's potential to broadly improve the condition of those afflicted by DMD, as they show that cardiosphere-derived cells exert salutary effects on cardiac and skeletal muscle," said Linda Marbán, Ph.D., Capricor's President and Chief Executive Officer. Capricor has submitted an FDA meeting request to discuss these results as well as next steps in its development of CAP-1002 for Duchenne muscular dystrophy, which includes plan to begin a clinical trial of intravenously-administered CAP-1002 in the latter half of this year. The Company believes the interim HOPE results may enable it to pursue one of the FDA's Expedited Programs for Serious Conditions, and that Capricor will apply for either or both of the Breakthrough Therapy and Regenerative Medicine Advanced Therapy (RMAT) designations for CAP-1002. The RMAT designation, intended to expedite the approval of safe and effective cell therapies, was created by the US Congress as part of the recently-enacted 21st Century Cures Act. Capricor expects to report top-line 12-month results from the HOPE-Duchenne Trial in Q4 2017. At the close of trading session on Tuesday, April 25, 2017, following the announcement, Capricor Therapeutics' stock price rose 4.53% to end the day at $3.23. A total volume of 3.24 million shares were exchanged during the session, which was above the 3-month average volume of 68.45 thousand shares. The Company's share price has surged 41.65% in the past three months and 21.43% on an YTD basis. The stock currently has a market cap of $72.45 million. Active Wall Street (AWS) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and micro-cap stocks. AWS has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below. AWS has not been compensated; directly or indirectly; for producing or publishing this document. The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third party research service company (the "Reviewer") represented by a credentialed financial analyst, for further information on analyst credentials, please email info@activewallst.com. Rohit Tuli, a CFA® charterholder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable-effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by AWS. AWS is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way. AWS, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. AWS, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, AWS, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice. This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither AWS nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://www.activewallst.com/disclaimer/. For any questions, inquiries, or comments reach out to us directly. If you're a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at: CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute. LONDON, UK / ACCESSWIRE / April 26, 2017 / Active Wall St. blog coverage looks at the headline from Capricor Therapeutics, Inc. (NASDAQ: CAPR) as the Company announced positive top-line results from a safety and exploratory efficacy analysis of six-month data from the randomized 12-month Phase I/II HOPE Clinical Trial of CAP-1002 (allogeneic cardiosphere-derived cells), an investigational candidate for the treatment of patients with Duchenne muscular dystrophy, or DMD. Register with us now for your free membership and blog access at: One of Capricor Therapeutics' competitors within the Biotechnology space, BioMarin Pharmaceutical Inc. (NASDAQ: BMRN), announced on April 20, 2017, that Jean-Jacques Bienaimé, the Company's Chairman and CEO, will host a conference call and webcast on Thursday, May 04, at 4:30 p.m. ET to discuss Q1 2017 financial results and provide a general business update. AWS will be initiating a research report on BioMarin Pharma in the coming days. Today, AWS is promoting its blog coverage on CAPR; touching on BMRN. Get all of our free blog coverage and more by clicking on the link below: The randomized HOPE (Halt cardiomyOPathy progression in Duchenne) clinical Trial was designed to evaluate the safety and exploratory efficacy of CAP-1002 in patients 12 years and older with DMD and who had cardiomyopathy, or heart disease, secondary to DMD as evidenced by scar in four or more left ventricular segments as detected by late gadolinium-enhancement MRI. Twenty-five patients were randomized to receive either a single dose of CAP-1002 or usual care. CAP-1002 was infused into each of the three main coronary arteries at a total dose of 75 million cells. Capricor stated that in exploratory efficacy analyses, statistically-significant improvements in systolic thickening of the inferior wall of the heart, and in the function of the middle and distal upper limb according to a PUL responder analysis, were observed in patients treated with CAP-1002 as compared to usual care control patients. Additionally, differences observed in several other cardiac and skeletal muscle measures, including cardiac scar were consistent with a treatment effect. CAP-1002 was generally safe and well-tolerated over the initial six-month follow-up period. Capricor has submitted a meeting request to the US Food and Drug Administration, or FDA, to discuss potential product registration strategies for CAP-1002 in the DMD indication. "These initial positive clinical results build upon a large body of preclinical data which illustrate CAP-1002's potential to broadly improve the condition of those afflicted by DMD, as they show that cardiosphere-derived cells exert salutary effects on cardiac and skeletal muscle," said Linda Marbán, Ph.D., Capricor's President and Chief Executive Officer. Capricor has submitted an FDA meeting request to discuss these results as well as next steps in its development of CAP-1002 for Duchenne muscular dystrophy, which includes plan to begin a clinical trial of intravenously-administered CAP-1002 in the latter half of this year. The Company believes the interim HOPE results may enable it to pursue one of the FDA's Expedited Programs for Serious Conditions, and that Capricor will apply for either or both of the Breakthrough Therapy and Regenerative Medicine Advanced Therapy (RMAT) designations for CAP-1002. The RMAT designation, intended to expedite the approval of safe and effective cell therapies, was created by the US Congress as part of the recently-enacted 21st Century Cures Act. Capricor expects to report top-line 12-month results from the HOPE-Duchenne Trial in Q4 2017. At the close of trading session on Tuesday, April 25, 2017, following the announcement, Capricor Therapeutics' stock price rose 4.53% to end the day at $3.23. A total volume of 3.24 million shares were exchanged during the session, which was above the 3-month average volume of 68.45 thousand shares. The Company's share price has surged 41.65% in the past three months and 21.43% on an YTD basis. The stock currently has a market cap of $72.45 million. Active Wall Street (AWS) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and micro-cap stocks. AWS has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below. AWS has not been compensated; directly or indirectly; for producing or publishing this document. The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third party research service company (the "Reviewer") represented by a credentialed financial analyst, for further information on analyst credentials, please email info@activewallst.com. Rohit Tuli, a CFA® charterholder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable-effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by AWS. AWS is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way. AWS, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. AWS, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, AWS, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice. This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither AWS nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://www.activewallst.com/disclaimer/. For any questions, inquiries, or comments reach out to us directly. If you're a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at: CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute.


Patent
Capricor | Date: 2014-11-26

Medical systems and methods for treating kidney disease alone, heart failure alone, chronic kidney disease with concomitant heart failure, or cardiorenal syndrome are described. The systems and methods are based on delivery of a natriuretic peptide such as Vessel Dilator to a subject. Methods for increasing and maintaining peptide levels at a certain concentration include direct peptide delivery via either an external or implantable programmable pump.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 794.43K | Year: 2011

DESCRIPTION (provided by applicant): It was recently discovered that the adult human heart contains small numbers of resident cardiac stem cells. These stem cells are incapable of mounting a full-scale repair of the heart following a heart attack (or myocardial infarction). However, when cultivated in the lab and delivered to animals after a myocardial infarction, these cells can initiate repair processes, form new heart muscle and new vessels. Capricor, Inc. has a method to cultivate resident cardiac stemcells which is known as the cardiosphere method. Cardiospheres can be generated starting with only a small cardiac biopsy that can be obtained during an outpatient procedure. The cardiosphere method is being developed for commercialization as an autologoustreatment for cardiovascular disease in general. This project aims to make the cardiosphere method faster, cheaper, and simpler. Cell culture techniques will be modified and product equivalence demonstrated by flow cytometry.es will be applied to determine the efficacy of each cell product. This project will also explore the feasibility of product banking, such that a patient could preserve stem cells for a future application. Cells will be subjected to a controlled-rate freeze followed by a thaw process after a period of banking in liquid nitrogen. Measures of viability and potency will be made to identify any detrimental effects. Finally, with a focus on future clinical trials, we will develop assays that will allow us to predict the potency, or efficacy,of a particular patient's sample. Another series of animal studies will be conducted to measure potency in the setting of myocardial infarction, while a series of simple lab potency assays will be developed in parallel as candidate predictors. Cardiosphere-derived stem cells are already being moved toward a Phase I/II clinical safety trial. The specific aims of this project will move Capricor toward its goal of preparing for a Phase II/III clinical efo provide a possible cure for the disease or halt its progression, and to improve the health of the Nation.


The present disclosure relates generally to methods for the increased processing of tissue for the generation of cardiac stem cells, wherein the stem cells are suitable for use in cardiac stem cell therapy. In particular, several embodiments relate to the processing of allogeneic donor cardiac tissue for the generation of multiple patient doses of cardiac stem cells.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: STTR | Phase: Phase I | Award Amount: 1.68M | Year: 2016

DESCRIPTION provided by applicant One of the most complex forms of congenital heart disease hypoplastic left heart syndrome HLHS affects an average of in every newborns with a mortality rate of up to percent during the first year of life The overall goal f our research is to develop safe and effective ways to improve short term and long term survival rates in babies born with HLHS We aim to introduce a novel cell based therapeutic strategy in the three stage surgical procedure that HLHS patients typically undergo Our hypothesis is that injected allogeneic cardiosphere derived cells CDCs will boost and regenerate the myocardium of the single right ventricle in HLHS patients improving right ventricular function and thus short and long term clinical outcomes The aims of this Phase I clinical trials are to evaluate the feasibility and safety of direct intra coronary injection of allogeneic CDCs in these HLHS patients at the time of cauterization for their second operation This proposal will translate a series of basic and pre clinical observations into a potentially paradigm shifting therapy to meet an unmet medical need in HLHS patients In addition this study will bring a deeper insight into the biology of stem cells in human patients which have never been studied before in pediatric congenital heart patients PUBLIC HEALTH RELEVANCE Hypoplastic left heart syndrome is one of the most complex forms of congenital heart disease with a reported incidence of of children born with congenital heart disease Despite these strides in medical care during the last twenty years the mortality rate of these infants remain at during the first year of life because mostly of right ventricle dysfunction This proposal will translate a series of basic and pre clinical observations into a potentially paradigm shifting cell based therapy to improve the right ventricular function and thus improve clinical outcomes


Medical systems and methods for treating kidney disease alone, heart failure alone, kidney disease with concomitant heart failure, or cardiorenal syndrome are described. The systems and methods are based on delivery of a chimeric natriuretic peptide to a patient. Methods for increasing peptide levels include direct peptide delivery via either an external or implantable programmable pump.


Patent
Capricor | Date: 2015-12-03

The invention encompasses methods for generating stable exosome formulations and encompasses stable exosome formulations. The exosome formulations encompass stable liquid exosome formulations and stable lyophilized exosome formulations. In some embodiments, the exosome formulations can be generated by ultrafiltration and diafiltration. The exosome formulations can be suitable for administration to a human.


The invention encompasses methods for generating exosomes comprising culturing cells in less than 20% oxygen for at least 2 days and harvesting exosomes from the cells. The invention further encompasses exosome preparations generated from cells cultured in less than 20% oxygen for at least 2 days.


Methods of treating heart failure, or decreasing blood pressure, comprising administering an NP at an appropriate does, or in an amount sufficient to provide particular concentrations of NP, are provided.


Therapeutic compositions containing chimeric natriuretic peptides for treating chronic kidney disease alone, heart failure alone, or chronic kidney disease with concomitant heart failure are described. The therapeutic compositions have enhanced stability characteristics to facilitate storage and delivery by provisioning apparatuses under conditions of elevated temperature and mechanical stress. Methods for increasing the stability of therapeutic compositions containing chimeric natriuretic peptides are further described.

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