Groundbreaking Study of Regenerative Medicine Therapy for Heart Failure

Posted Date: 7/31/2013

Michigan CardioVascular Institute Research Department at Covenant HealthCare Joins Groundbreaking Study of Novel Regenerative Medicine Therapy for Heart Failure

First-of-its-Kind Investigational Drug May Enhances Body’s Stem Cell Response at Site of Cardiovascular Injury

Saginaw, MI – Michigan CardioVascular Institute (MCVI) cardiovascular disease specialists at Covenant HealthCare announced this week they have enrolled their first patient into a clinical trial of a novel gene therapy technique to promote regeneration of the heart in patients suffering from heart failure. 

The study, being conducted by MCVI Research Department at Covenant HealthCare is exploring the efficacy of an experimental gene drug designed to heal a damaged heart by encouraging the body to deploy more stem cells to site of the injury than it normally would.

Heart failure (HF) occurs when the muscle of the heart becomes weakened and cannot pump blood sufficiently throughout the body. The injury is most often caused by inadequate blood flow to the heart resulting from chronic or acute ischemic cardiovascular disease, including heart attacks. Affecting more than five million people in the United States alone, heart failure is a leading cause of death, disability and hospitalization. 

Considerable scientific evidence has emerged over the past decade demonstrating the high therapeutic potential of stem cell-based regenerative medicine for a host of diseases. Stem cells are the building blocks for every organ, tissue and cell in the human body. They have the unique ability to develop into many different cell types, and in many tissues serve as an internal repair system, dividing essentially without limit to replenish other cells.

According to Principal Investigator, Dr. Safwan Kassas, “the way the human body deals with protein regulation will be the wave of the future for all of mankind’s significant incapacitating diseases, the STOP-HF Trial; is of paramount importance for the future of this type of therapy.”

Sponsored by Juventas Therapeutics, the STOP-HF Trial is a randomized, placebo-controlled, double blinded Phase II study evaluating the safety and efficacy of the drug JVS-100 in patients with late-stage heart failure.  JVS-100 is a gene therapy that directs the heart muscle to produce Stromal cell-Derived Factor 1 (SDF-1), a protein which has been shown to repair damaged tissue in the body through the recruitment of circulating stem cells to the site of injury, prevention of ongoing cell death and restoration of blood flow.

Earlier this year, Juventas reported 12-month results from its Phase I study of JVS-100 in Class III ischemic heart failure patients. In addition to meeting the primary safety endpoint, patients in the study who received the drug demonstrated clinically significant improvements at 12 months in exercise

MCVI with Covenant HealthCare is one of just a dozen leading US medical sites participating in the STOP-HF Trial.  Other prominent institutions involved include the Center for Therapeutic Angiogenesis (Birmingham, Alabama), Columbia University Medical Center, the University of Utah Medical Center, Summa Health System and the University of South Florida.  The study will enroll 90 patients nationwide.

Media Inquiries:

Contact:            Kristin Knoll, Covenant HealthCare Public Relations 989.583.7655

                        Katie Mostek, MCVI Research Department 989.754.3555 extension 4187

About Juventas Therapeutics:

Juventas Therapeutics, headquartered in Cleveland, OH, is a privately held clinical-stage biotechnology company developing a pipeline of regenerative therapies to treat life–threatening diseases. Founded in 2007 with an exclusive license from Cleveland Clinic, Juventas has transitioned its therapeutic platform from concept to initiation of mid-stage clinical trials for treatment of heart failure and critical limb ischemia. Investors include New Science Ventures, Takeda Ventures, Triathlon Medical Venture Partners, Venture Investors, Early Stage Partners, Fletcher Spaght Ventures, Reservoir Venture Partners, Glengary, The Global Cardiovascular Innovation Center, Tri-State Growth Fund, North Coast Angel Fund, X Gen Ltd., JumpStart Inc., and Blue Chip Venture Co. The company has received non-dilutive grant support through the Ohio Third Frontier-funded Cleveland Clinic Ohio BioValidation Fund, Global Cardiovascular Innovation Center and Center for Stem Cell & Regenerative Medicine.

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