Juventas Therapeutics Reports One Year Data From Phase I Heart Failure Clinical Trial
CLEVELAND, Jan. 30, 2012 /PRNewswire-USNewswire/ -- Juventas Therapeutics is a privately-held, clinical-stage company developing novel regenerative therapies for treatment of cardiovascular disease. The Company's lead product, JVS-100, encodes Stromal cell-Derived Factor 1 (SDF-1) which has been shown to repair damaged tissue through recruitment of circulating stem cells to the site of injury, prevention of ongoing cell death and restoration of blood flow. Juventas recently presented the 12-month results from its Phase I heart failure trial at the 7th International Conference on Cell Therapy for Cardiovascular Disease.
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The 17-person, open-label, dose-escalation study targeted New York Heart Association (NYHA) class III heart failure patients, who represent approximately a quarter of the 6 million heart failure patients in the United States and account for half of all heart failure hospital admissions. The clinical trial met its primary safety endpoint with no serious adverse events deemed drug related. Fifteen of the 17 patients survived to a year. Importantly, patients receiving target therapeutic doses demonstrated clinically significant improvements at 12 months in 6 minute walk distance (6MWD) and the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Nearly half of the patients improved a full NYHA class, with multiple patients improving 2 full classes.
"The patient population we treated in this trial have a true unmet clinical need and tend to have rapidly deteriorating quality of life," states Marc Penn, M.D., Ph.D, Founder and Chief Medical Officer for Juventas and Director of Cardiovascular Research at the Summa Cardiovascular Institute at Summa Health System. "To see clinical symptomatic benefits of this magnitude maintained from 4 to 12 months after JVS-100 treatment suggests we are inducing fundamental changes in the heart of treated patients. We believe this is consistent with our understanding of the mechanisms associated with JVS-100 and warrants further investigation."
Based on these results, the company is preparing to enroll a placebo-controlled, randomized, double blinded Phase II heart failure clinical trial in the United States to further define the efficacy of JVS-100. Also, Juventas has received FDA clearance to enroll a Phase IIa trial evaluating safety and efficacy of JVS-100 in patients with critical limb ischemia. The CLI trial is enrolling patients in the United States and India. In addition to safety, the trial will assess time to amputation and other efficacy endpoints and will begin enrollment in the first quarter of 2012.
"We are thrilled by our Phase I data and excited to be transitioning into multiple mid-stage clinical trials," states Rahul Aras, Ph.D., President and CEO for Juventas. "We are excited about the platform potential for JVS-100 in a broad range of clinical indications."
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 the Cleveland Clinic, Juventas has transitioned its therapeutic platform from concept to initiation of mid-stage clinical trials. Investors include New Science Ventures, Takeda Ventures, Triathlon Medical Venture Partners, Early Stage Partners, Fletcher Spaght Ventures, Reservoir Venture Partners, 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.
About JVS-100
The company's lead product, JVS-100 encodes Stromal–cell Derived Factor 1 (SDF–1). SDF-1 promotes tissue repair through recruitment of endogenous stem cells to the damaged organ, promotion of new blood vessel formation and prevention of ongoing cell death. The SDF-1 repair pathway is well-conserved in a broad range of end organ systems, including the heart, vasculature, dermis, kidney, and eye. JVS-100 is currently being clinically evaluated for treatment of heart failure and late stage peripheral vascular disease and has been shown to protect and repair tissue following organ–damage in a broad range of pre–clinical disease models.
SOURCE Juventas Therapeutics
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