Juventas Therapeutics, Inc., a clinical-stage biotechnology company developing novel non-viral gene therapies that activate natural processes to repair the body, today announced that its product candidate, JVS-100, received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of advanced ischemic chronic heart failure. The FDA Fast Track process is designed to expedite the development and review of drugs to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. The FDA has also allowed the protocol for the company's Phase 2b double-blinded, randomized clinical trial of JVS-100 for the treatment of advanced ischemic chronic heart failure in patients with a prior history of heart attack, referred to as STOP-HF2. 

"The Fast Track designation by the FDA is intended to facilitate the development of drug candidates like JVS-100," stated Eugene Chung, M.D., FACC, director of heart failure, Ohio Heart and Vascular Center. "The patients we will be treating have advanced ischemic chronic heart failure that is being managed with optimal guideline-based therapy. In many cases, the next therapeutic option involves implantation of a left ventricular assist device (LVAD) or heart transplant. JVS-100 may provide a viable therapy for these patients that currently have no other non-surgical options." 

The STOP-HF2 trial is expected to enroll up to 180 patients at as many as 40 clinical centers in a double-blinded, 1:1 randomized, sham-controlled study evaluating the impact of two administrations of 30 mg doses of JVS-100 in heart failure patients with low ejection fraction (less than or equal to 35%) and elevated serum biomarkers (NTproBNP greater than or equal to 500 pg/mL). The first dose will be delivered at the time of patient enrollment and the second will be delivered six months later, each by endomyocardial injection catheter to the left ventricle of the heart.

For more details, go to: http://www.prnewswire.com/news-releases/juventas-therapeutics-granted-fda-fast-track-designation-and-phase-2b-protocol-allowance-for-novel-heart-failure-gene-therapy-300099342.html