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HOPE-2 Trial Underway
Capricor, Inc. has initiated the HOPE-2 clinical trial to test the safety and efficacy of Capricor’s novel cellular therapy, CAP-1002, in boys and young men with Duchenne muscular dystrophy (DMD).

Up to 84 boys and young men with DMD will be enrolled in HOPE-2, a Phase II, randomized, double-blind, placebo-controlled trial that will test CAP-1002 in participants with advanced stages of DMD.
 
Participants in the HOPE-2 trial will be randomized to receive either CAP-1002 or placebo, delivered intravenously every three months for a total of four administrations. Participants will be followed for a one-year period following randomization. An open label extension is planned for the placebo group if trial evidence suggests an appropriate risk/benefit profile of CAP-1002. For more information, please visit www.HOPE2Trial.com or the ClinicalTrials.gov site.
Want to Enroll in HOPE-2?
Please visit our website to get the latest information on sites where the trial will be conducted. We currently have sites in Davis, CA; Salt Lake City, UT; Aurora, CO, and St. Louis, MO. We will be adding more sites as they get activated. So keep checking.
Please Join Us for a PPMD Webinar on HOPE-2
When: 1 p.m. ET, July 18, 2018
Access code: 9449985
Phone: 866.740.1260
Access code: 9449985
For more information and to register for the webinar, please click here.
Replays of the webinar will be available by visiting the PPMD website.
Learn More about HOPE-2
Watch PBS TV Interview with Capricor President and CEO Linda Marbán
PBS recently broadcast its interview with Dr. Marbán, and you can watch it online by clicking here. She discussed DMD, the HOPE-2 trial and Capricor's investigational therapy for DMD, CAP-1002.
HOPE-Duchenne Trial Results: Single Dose of CAP-1002 Produced Signals of Significant and Sustained Improvements In  Heart and Skeletal Muscle Function
Capricor’s previous clinical trial, the HOPE-Duchenne trial, evaluated the safety and efficacy of a single dose of CAP-1002 in boys and young men with heart disease related to DMD. It found CAP-1002 was generally safe, well tolerated and demonstrated significant and sustained signals of improvement in cardiac and skeletal muscle function.

"Because Duchenne muscular dystrophy is a devastating, muscle-wasting disease that causes physical debilitation and eventually heart failure, the improvements in heart and skeletal muscle in those treated with a single dose of CAP-1002 are very promising and show that a subsequent trial is warranted," said Ronald G. Victor, M.D., associate director for clinical research at the Smidt Heart Institute at Cedars-Sinai Medical Center and a lead investigator for the HOPE-Duchenne trial. "These early results provide hope for the Duchenne community, which is in urgent need of a major therapeutic breakthrough."

The HOPE-Duchenne trial was funded in part by the California Institute of Regenerative Medicine.

For more information, please click here.
 
Open Label Trial for HOPE-Duchenne Participants
Capricor is offering an open-label trial of CAP-1002 to HOPE-Duchenne clinical trial participants who received placebo, rather than CAP-1002. Participants eligible for the open-label trial will be contacted by the study site where they participated in the original trial.
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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 biological therapeutics for the treatment of rare disorders. Capricor’s lead candidate, CAP-1002, is an allogeneic cell therapy that is currently in clinical development for the treatment of Duchenne muscular dystrophy.

Capricor has also established itself as one of the leading companies investigating the field of extracellular vesicles and is exploring the potential of CAP-2003, a cell-free, exosome-based candidate, to treat a variety of disorders. For more information, please visit www.capricor.com .  
Cautionary Note Regarding Forward-Looking Statements
Statements in this newsletter 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; regulatory developments involving products, including the ability to obtain regulatory approvals or otherwise bring products to market; 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, 2017 as filed with the Securities and Exchange Commission on March 22, 2018, in its Registration Statement on Form S-3, as filed with the Securities and Exchange Commission on September 28, 2015, together with the prospectus included therein and prospectus supplements thereto and in its Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, as filed with the Securities and Exchange Commission on May 14, 2018. 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. CAP-2003 has not yet been approved for clinical investigation.

 
Capricor Therapeutics Inc.| www.Capricor.com