Juventas Therapeutics initiates Phase II RETRO-HF clinical trial enrollment for patients with heart failure
CLEVELAND, Feb. 4, 2014 /PRNewswire-USNewswire/ -- Juventas Therapeutics, a privately-held, clinical-stage company developing novel regenerative therapies for the treatment of cardiovascular disease, announced today that it has initiated enrollment of the Phase II RETROHF clinical trial to evaluate safety and efficacy of JVS-100 delivered via retrograde infusion to patients with symptomatic heart failure. Coprincipal investigators for the trial are Drs. Amit Patel, M.D., Director of Cardiovascular Regenerative Medicine at the University of Utah, and Eugene Chung, M.D., Director of Heart Failure Program at the Ohio Heart and Vascular Center.
This Phase II study follows the successful enrollment of the open-label, dose-escalation Phase I portion of the RETRO-HF program. The multi-center trial enrolled 12 patients with heart failure who received JVS-100 at 30 mg or 45 mg via retrograde infusion. RETRO-HF is the first clinical trial in the world to use the minimally invasive technique of retrograde infusion via the coronary sinus for delivery of a gene therapy to the heart.
"The Phase I study demonstrated that retrograde infusion is a safe procedure through which we can deliver biologics to the heart," states Dr. Patel. "We are excited to collaborate with additional clinical centers to initiate and complete the Phase II component of the trial."
The randomized, double-blinded, placebo-controlled Phase II RETRO-HF trial will enroll 60 patients with symptomatic heart failure to receive JVS-100 at 30 mg or 45 mg or placebo. Heart failure affects nearly six million Americans, with an estimated annual cost to our healthcare system of $40 billion. The patients targeted for treatment with JVS-100 have advanced stages of heart failure where their therapeutic options are usually limited to a heart transplant or a mechanical assist device. The trial will enroll at 15 centers across the United States.
"JVS-100 has been safely delivered to over 125 patients in three different randomized, double-blinded, placebo-controlled clinical trials," states Dr. Chung. "We are excited to study JVS-100's clinical potential in symptomatic heart failure patients. The novel retrograde delivery method may provide additional delivery options for patients for whom there are few therapeutic options."
"JVS-100 is a non-viral plasmid that expresses stromal cell-derived factor 1 (SDF-1), which has been shown to activate natural stem cell based repair pathways and improve cardiac function in pre-clinical and Phase I clinical studies," states Dr. Marc Penn, M.D., Ph.D., Chief Medical Officer for Juventas Therapeutics, Director of the Skirball Laboratory for Cardiovascular Cellular Therapeutics, and Director of Cardiovascular Research at Summa Health System. "It's a fundamental biology that we identified several years ago and are targeting to improve patients' lives."
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. The first clinical targets will be treatment of patients with symptomatic heart failure and critical limb ischemia. The company has demonstrated in pre-clinical models 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, Juventas is also developing JVS-100 for additional indications including acute myocardial infarction, chronic angina, and muscle regeneration.