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NEOMED Researcher Makes Breakthrough in Regenerative Therapy for Those Suffering Heart Failure

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ROOTSTOWN, Ohio, June 9 -- Northeast Ohio Medical University (formerly the Northeastern Ohio Universities Colleges of Medicine and Pharmacy) issued the following news release:

Northeast Ohio Medical University (NEOMED) researcher Marc Penn, M.D., Ph.D.,FACC has a novel approach to regenerative medicine focused on inducing the bodies own stem cells to repair tissue, rather than injecting stem cells, and his recent clinical trial with patients who have experienced advanced heart failure is showing significant results.

Dr. Penn recently shared the results of his Phase II study that evaluates the safety and efficacy of a gene therapy approach in patients with a type of heart disease called symptomatic ischemic cardiomyopathy at the European Society of Cardiology- Heart Failure Congress in Athens, Greece. The study showed that the gene therapy approach which is under development by Juventas Therapeutics (Cleveland, Ohio) is safe and improved cardiac function in patients with advanced heart failure, who on average had their last heart attacks more than a decade ago.

A heart attack results in a weakening of the heart muscle, causing the heart to increase in size, which actually decreases the level of blood being pumped through the body. Ultimately patients can develop fatigue and have difficulties performing the activities of daily living. Dr. Penn's recent clinical trial, STOP-HF, enrolled patients who were on average 65 years old, had symptomatic heart failure and had experienced a heart attack approximately 11 years prior. JVS-100 (a piece of DNA that makes a protein called SDF-1) was injected into the heart tissue of some of the patients. The result of the trial showed that JVS-100 reduced the size of the heart by over 30 ml compared to patients who received placebo.

"This is an important milestone in our development of SDF-1 as a first-in-class therapy for heart failure," said Dr. Penn, professor of integrative medical sciences in the College of Medicine at NEOMED and director of cardiovascular research at Summa Health System, Akron, Ohio. Dr. Penn is also the founder and chief medical officer for Juventas Therapeutics, Inc. in Cleveland, Ohio, which is developing SDF-1 over-expression for the prevention and treatment of injured tissue. "We've observed consistent and positive responses that provide strong support for JVS-100 bioactivity in patients with a history of a heart attack that have progressed to symptomatic heart failure. The level of improvement we observed is consistent with that seen in stem cells trials for heart failure. The constellation of our findings go a long way to validating our hypothesis of 15 years ago that activating stem cells already present in the body is sufficient to induce cardiac repair, and that stem cell injections may ultimately prove unnecessary. We are proud of the our ability translate our bench science to offer hope to patients with symptomatic heart failure, and we are grateful to the NEOMED and Summa Health System for the support as well as the investors and collaborators at Juventas Therapeutics, without whom this clinical translation would not have been possible."

About JVS-100

JVS-100, is a non-viral plasmid that encodes for stromal cell-derived factor-1 (SDF-1). SDF-1 promotes cardiac function and tissue repair following a heart attack through activation of the body's natural stem-cell based regenerative repair processes. JVS-100 is the subject of active clinical programs in heart failure (HF) and critical limb ischemia (CLI). JVS-100 is the focus of an on-going Phase II blinded, randomized, placebo-controlled trial, RETRO-HF, which is currently enrolling patients similar to those enrolled in STOP-HF with delivery via coronary sinus infusion.

About the STOP-HF Phase II Trial

STOP-HF is an exploratory Phase II study of 93-patients in a double-blind, randomized, placebo-controlled trial being conducted at 15 centers in the United States to evaluate safety and efficacy of a single treatment of JVS-100, a plasmid stromal cell-derived factor 1 (SDF-1) delivered via injection to the endocardium and myocardium of patients with ischemic heart failure.

Patients enrolled in STOP-HF have a prior history of a heart attack and years later developed symptomatic heart failure as defined by an ejection fraction (a measurement of how well your heart is pumping) less than or equal to 40 percent and poor quality of life and exercise tolerance as measured by the Minnesota Living with Heart Failure Questionnaire (MLWHQ) and six minute walk distance (6MWD), respectively.

Endpoints of STOP-HF include objective echocardiographic parameters of left ventricular remodeling and biomarkers as well as subjective clinical measures of clinical status in heart failure patients.

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