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 results from its Phase I heart failure trial at the 14th Annual Meeting of the American Society of Gene and Cell Therapy.

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."

Source: Juventas Therapeutics, Inc