LOS ANGELES, June 19, 2014 (GLOBE NEWSWIRE) -- Capricor Therapeutics, Inc. (OTCBB:CAPR), a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, today announced that Dr. Rachel Ruckdeschel Smith, Ph.D., Vice President of Research and Development at Capricor, participated in a panel discussion on the regulation of therapeutic products derived from human stem cells at the DIA 2014 50th Annual Meeting, being held June 15-19, 2014 in San Diego, California.
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. The forum was chaired by Torrey Cope, JD, Partner at Sidley Austin LLP and co-paneled by Dr. Ruckdeschel Smith and two other panelists.
Commenting on the discussion, Dr. Ruckdeschel Smith said, "Stem cell-derived therapeutic products are a largely new challenge for regulators across the globe. At Capricor, we strive for open communication with U.S. regulators to discuss trial objectives and designs, a strategy that helps ensure we are in tune with what regulators are most interested in learning from our studies. This early and often communications philosophy with the FDA also enables us to actively manage every aspect of our trials and optimally gear them toward success. Cell therapy has immense potential for therapeutic benefit and we look forward to continuing our constructive relationship with regulators."
About Capricor Therapeutics
Capricor Therapeutics, Inc. (CAPR), a publicly-traded biotechnology company, is focused on the development of novel therapeutics to prevent and treat cardiovascular diseases. Capricor Therapeutics has two leading product candidates: CAP-1002 and Cenderitide. Capricor Therapeutics was formed through the November 2013 merger between Capricor, Inc., a privately-held company whose mission is to improve the treatment of heart disease by commercializing cardiac stem cell therapies for patients, and Nile Therapeutics, Inc., a clinical-stage biopharmaceutical company developing innovative products for the treatment of cardiovascular diseases. Capricor Therapeutics' stock began trading under the symbol "CAPR" on December 20, 2013. For additional information, please 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; 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 our business are set forth in our Form 10-K for the year ended December 31, 2013, as filed with the Securities and Exchange Commission on March 31, 2014, our Form 10-Q for the quarter ended March 31, 2014, as filed with the Securities and Exchange Commission on May 15, 2014, and in our Amendment No. 1 to Registration Statement on Form S-1, as filed with the Securities and Exchange Commission on May 23, 2014. All forward-looking statements in this press release are based on information available to us as of the date hereof, and we assume no obligation to update these forward-looking statements.
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