Juventas Therapeutics Phase II Clinical Study Results to be Presented at 2014 American Heart Association Scientific Sessions
CLEVELAND, Ohio, Nov. 12, 2014—Juventas Therapeutics Inc., a privately-held, clinical-stage company developing novel therapies for treatment of cardiovascular disease, today announced that investigators will present results from two independent clinical trials that show JVS-100, a non-viral gene therapy expressing stromal cell-derived factor 1 (SDF-1), improves clinical status of patients with critical limb ischemia (CLI) and symptomatic ischemic heart failure at the American Heart Association Scientific Sessions 2014 on Nov. 17 in Chicago, Ill.
JVS-100, Juventas’ lead development asset, has been shown to promote tissue repair in multiple indications through activation of natural regenerative repair pathways. The findings from two randomized placebo controlled trials, STOP-CLI, testing JVS-100 in patients with critical limb ischemia, and STOP-HF, testing JVS-100 in patients with advanced heart failure, highlight the safety and potential efficacy of Juventas’ novel gene therapy strategy.
“More than 200 patients have received JVS-100 therapy to date, and the results show potential for clinically-meaningful benefit in treatment of cardiovascular diseases through JVS-100 ability to activate endogenous tissue repair,” said Marc Penn, MD, PhD, FACC, Founder and Chief Medical Officer of Juventas Therapeutics and Director of Research at Summa Cardiovascular Institute, Summa Health System in Akron, Ohio.
Leslie Miller, MD, of Florida Hospital Pepin Heart Institute, Co-Principal Investigator for STOP-HF, will provide an update on STOP-HF on Nov. 17 at 9:30 a.m. at the American Heart Association Scientific Sessions. STOP-CLI Principal Investigator Melina Kibbe, MD, of Northwestern University Feinberg School of Medicine, will present the results of STOP-CLI at 4:30 p.m.
About Juventas Therapeutics
Juventas Therapeutics, headquartered in Cleveland, Ohio, is a privately-held, clinical-stage biotechnology company developing regenerative therapies for cardiovascular disease. Founded in 2007 with an exclusive license from the Cleveland Clinic, Juventas has transitioned its therapeutic platform from concept to mid-stage clinical trials for treatment of heart failure and critical limb ischemia. Investors include New Science Ventures, Triathlon Medical Venture Partners, Takeda Ventures, Early Stage Partners, Fletcher Spaght Ventures, Venture Investors, Reservoir Venture Partners, The Cleveland Clinic, Glengary, North Coast Angel Fund, X Gen Ltd., JumpStart Inc., and Blue Chip Venture Co. The company has received support through the Ohio Third Frontier funded Cleveland Clinic Ohio BioValidation Fund, Global Cardiovascular Innovation Center, and Center for Stem Cell and Regenerative Medicine.
The company's lead product, JVS-100, encodes stromal–cell derived factor 1 (SDF-1). JVS-100 is a non-viral DNA plasmid that has been shown to protect and repair tissue following organ-injury in a broad range of pre-clinical disease models. Pre-clinical models have shown that JVS-100 therapy has the potential to repair tissue-damage following ischemic injury by recruiting the body's own stem cells to the damaged region, the prevention of cardiac cell death and promotion of new blood vessel growth in the heart. In addition to heart failure and critical limb ischemia, Juventas is also developing JVS-100 for additional indications including acute myocardial infarction, chronic angina, and muscle regeneration.