Juventas Therapeutics Presents Phase II Data at AHA Scientific Sessions That Shows JVS-100 is Safe, Potentially Effective in Patients with Critical Limb Ischemia
CLEVELAND, Ohio, Nov. 18, 2014—Juventas Therapeutics Inc., a privately-held, clinical-stage company developing novel therapies for treatment of cardiovascular disease, had clinical data presented at the American Heart Association Scientific Sessions 2014 that show JVS-100 was safe and well tolerated while demonstrating clinically meaningful improvement in patients with critical limb ischemia (CLI).
Melina Kibbe, MD, of Northwestern University Feinberg School of Medicine, presented the data, marking the first public presentation of this data. The primary objectives of the study were to evaluate the safety and tolerability of escalating doses of JVS-100, a non-viral gene therapy expressing stromal cell-derived factor 1 (SDF-1), delivered via direct intramuscular injection to patients with CLI.
Critical limb ischemia (CLI) is a severe form of peripheral artery disease that results from severe blockage of the arteries in the lower extremities, caused by atherosclerosis, the hardening and narrowing of the arteries over time due to the buildup of fatty deposits called plaque. CLI is a chronic condition that results in severe pain in the feet or toes, as well as skin ulcers. Left untreated, the complications of CLI may result in amputation of the affected limb. There are an estimated three million Americans that suffer with CLI.
STOP-CLI is a phase IIa, randomized, double blind, placebo-controlled dose escalation study to evaluate the safety and initial efficacy of JVS-100 in patients with CLI. With 48 subjects enrolled, JVS-100 met its primary safety endpoint and demonstrated consistent, dose-dependent improvement relative to placebo across multiple clinical efficacy parameters.
STOP-CLI data shows:
- JVS-100 delivery by intramuscular injection to subjects with CLI was safe with no unanticipated drug-related serious adverse events (SAEs).
- Patients treated with JVS-100 demonstrated consistent dose-dependent improvement across multiple clinical efficacy parameters, including quality of life (QoL), pain reduction and ulcer closure.
- There was no significant difference in amputation rates between the placebo and JVS-100 treated patients. The overall amputation rate for the study was less than 10% and larger studies will be needed to understand the effect of JVS-100 on amputation free survival.
“CLI is devastating disease that can lead to tissue death and limb amputation, and the patients who suffer from this disease have limited therapeutic options,” said Kibbe. “The safety and efficacy data from STOP-CLI demonstrate the potential of JVS-100 to stimulate the body’s natural repair system, and we look forward to further evaluation of this therapy in future clinical studies.”
Juventas also presented an update at the AHA Scientific Sessions from STOP-HF, a phase II study of 93 patients with symptomatic ischemic cardiomyopathy in a double-blind, randomized, placebo-controlled trial to evaluate safety and efficacy of JVS-100. These interim topline trial results showed that JVS-100 improves cardiac function in patients with advanced heart failure more than a decade after having a heart attack.
“JVS-100 has been administered to more than 200 patients across multiple clinical indications including critical limb ischemia and heart failure,” stated Rahul Aras, President and CEO of Juventas Therapeutics. “JVS-100 is proving safe and holds promise for therapeutic efficacy in treating cardiovascular disease.”
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.