Capricor Therapeutics Inc (CAPR)

[CDut1]

Capricor Therapeutics Reports Second Quarter 2014 Financial & Business Highlights

Recent Operational Highlights:

Company announced that MRI data collected on the patients in the Phase I open-label dose-escalation study of the allogeneic CDC product (CAP-1002) revealed that those patients who would be included in the Phase II clinical study by virtue of dose and tissue type compatibility, exhibited measurable improvements in ejection fraction, a global measure of the heart's pumping ability. In those patients, ejection fraction improved from an average of 38.9% at baseline to 44.1% at six-month follow-up. Measurements of infarct (scar) size, viable mass, and regional function also showed quantifiable improvements;
CNN aired a story during Sanjay Gupta's program discussing Capricor's ALLSTAR clinical trial. For the full story click here: http://www.cnn.com/2014/07/11/health/stem-cells-heart-damage/index.html?hpt=he_c1
Company entered into an Exclusive License with Cedars-Sinai Medical Center for its exosomes-related IP portfolio.
Dr. Linda Marban, Chief Executive Officer of Capricor, said, "During this past quarter we continued to execute on our strategy as we announced encouraging analysis of the MRI data at the six-month time point from our Phase I ALLSTAR trial. We are pleased with the six-month data as there are indications of both myocardial regeneration as well as possible functional improvements. We are progressing with Phase II of our ALLSTAR clinical trial and look forward to reporting on our next milestone. With our initiatives to advance our lead candidate, CAP-1002, we are clearly positioning Capricor strategically to be a leader in the cardiac therapy space."

Dr. Marban further stated, "We continue to gain recognition in the industry and have presented findings at notable symposiums and forums over the past few months. In May, we presented findings from a preclinical study on exosomes, Capricor's newly licensed platform technology, at the 11th International Symposium on Stem Cell Therapy and Cardiovascular Innovations. The preclinical study sponsored by Cedars-Sinai Medical Center showed that exosomes were able to improve cardiac function and reduce the damage resulting from a heart attack. Dr. Rachel Ruckdeschel Smith, Ph.D., Vice President of Research and Development at Capricor, outlined the study findings, which were published in the May issue of Stem Cell Reports, the official journal of the International Society for Stem Cell Research (ISSCR)."

In June, the Company announced that Dr. Rachel Ruckdeschel Smith participated in a panel discussion on the regulation of therapeutic products derived from human stem cells at the Drug Information Association (DIA) 2014 50th Annual Meeting. The forum, titled "FDA Regulation of Therapeutic Products Derived from Human Stem Cells: Successfully Navigating the Regulatory Hurdles" (#135), addressed the basic regulatory requirements for therapeutic products derived from human stem cells as biological drugs, common hurdles that arise in research and development, and options for addressing those hurdles.

In late June, during the BIO International Convention, Dr. Marban presented during a panel at the first, all-day Regenerative Medicine Forum organized by the California Institute for Regenerative Medicine (CIRM), in association with the Alliance for Regenerative Medicine (ARM) and the International Society for Stem Cell Research (ISSCR). The panel, titled "Commercializing a New Therapeutic Modality—Case Studies", was moderated by Randall Mills, President and CEO of CIRM. It focused on the importance of clinical data in bringing cell-based therapies to market, the role of clinical data at every step of the process, the importance of involving regulators early and often in the pathway to market, as well as how the players in reimbursement in this field are responding to these new approaches.

http://finance.yahoo.com/news/capricor-therapeutics-reports-second-quarter-141855371.html