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"Although we remain disappointed with last week's interim results from the ALLSTAR clinical trial of CAP-1002 in the heart attack setting, in which a signal on the parameter of change in cardiac scar size was not observed, the inconsistency of the placebo response with the well-established natural history of this disease process as well as the divergence from the extensive record observed with our cell technology together warrant the conduct of further analyses to understand the factors that led to these unexpected observations," added Dr. Marbán. "The observed reductions in left ventricular volume measures in the CAP-1002 treated patients, an important indicator of reverse remodeling of the heart, support the biological activity of CAP-1002." The Company reported a net loss of approximately $3.7 million, or $0.17 per share, for the first quarter of 2017, compared to a net loss of approximately $4.3 million, or $0.26 per share, for the first quarter of 2016. As of March 31, 2017, the Company's cash, cash equivalents and marketable securities totaled approximately $11.7 million compared to approximately $16.2 million on December 31, 2016. Capricor believes that its current financial resources, including the proceeds from the recently-completed private placement, should be sufficient to fund its operations and meet its financial obligations through the first quarter of 2018 based on the Company's current projections. Capricor Therapeutics, Inc. (NASDAQ: CAPR) is a clinical-stage biotechnology company developing first-in-class biological therapies for cardiac and other medical conditions. Capricor's lead candidate, CAP-1002, is a cell-based candidate currently in clinical development for the treatment of Duchenne muscular dystrophy, myocardial infarction (heart attack), and heart failure. Capricor is exploring the potential of CAP-2003, a cell-free, exosome-based candidate, to treat a variety of disorders. For more information, visit www.capricor.com. The ALLSTAR and HOPE-Duchenne clinical trials are funded in part by the California Institute for Regenerative Medicine. Statements in this press release regarding the efficacy, safety, and intended utilization of Capricor's product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of 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, expectations with respect to the expected use of proceeds from the recently completed offerings and the anticipated effects of the offerings, 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 is set forth in Capricor's Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the Securities and Exchange Commission on March 16, 2017, and in its Registration Statement on Form S-3, as filed with the Securities and Exchange Commission on September 28, 2015, together with prospectus supplements thereto. 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. CAP-1002 is an Investigational New Drug and is not approved for any indications. Capricor's exosomes technology, including CAP-2003, has not yet been approved for clinical investigation. For more information, please contact: To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/capricor-therapeutics-reports-first-quarter-2017-financial-results-and-provides-corporate-update-300457779.html


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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