Juventas Therapeutics, Inc. Demonstrates JVS-100 Delivery to Patients with Heart Failure is Safe and Provides Clinical Benefit
Published: May 25, 2011
The 17-person, open-label, dose-escalation study targeted New York Heart Association (NYHA) class III heart failure patients. Class III patients 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.
"We wanted to target truly sick patients for whom there are currently no real therapeutic options," states Marc Penn, M.D., Ph.D., scientific founder and Chief Medical Officer for Juventas. "These patients tend to have a rapidly deteriorating quality of life and the potential to provide clinical benefit is meaningful."
The clinical trial met its safety endpoints and JVS-100 was well-tolerated by all patients at all doses tested. At four months post-treatment, patients in the targeted therapeutic dose range, are showing clinically-relevant and statistically-significant median improvements of 36 meters for 6 minute walk distance (6MWD) and 22 points in the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Nearly half of the patients improved a full NYHA heart class and, importantly, no patients worsened in heart class. Echocardiographs demonstrated that the patients' cardiac function stabilized with dose-dependent trends toward improvement in left ventricular end systolic volume (LVESV) and left ventricular ejection fraction (LVEF).
"While the focus of the trial was safety, it is encouraging to see such robust clinical benefit in the treated patients," states Douglas Losordo, M.D., principal investigator for the trial and Director of the Feinberg Cardiovascular Research Institute at the Northwestern University School of Medicine. "These are exciting results for the cardiovascular regenerative medicine field."
Patients in the trial were also enrolled at Cardiology, P.C. (Birmingham, AL) , Rush University Medical Center (Chicago, IL), and Columbia University Medical Center(New York, NY).
"We're very pleased with the outcome of this study, which builds on more than ten years of research surrounding SDF-1, its role in stem cell homing and tissue repair," indicates Rahul Aras, Ph.D., President & Chief Executive Officer for Juventas. "We believe JVS-100 provides a clinically attractive means through which to provide regenerative therapy without the complexity often associated with cell therapy. It has the potential to simplify the treatment paradigm for both the physician and patient."
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 lifethreatening 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 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.
The company's lead product, JVS-100 encodes Stromalcell Derived Factor 1 (SDF1). 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 organdamage in a broad range of preclinical disease models.
SOURCE Juventas Therapeutics, Inc.