Juventas Therapeutics announced that the Food and Drug Administration (FDA) has granted Fast Track designation to JVS-100 for the treatment of advanced ischemic chronic heart failure.
The FDA has also approved 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 STOP-HF2 trial will enroll up to 180 patients in a double-blinded, 1:1 randomized, sham-controlled study evaluating the impact of two administrations of 30mg doses of JVS-100 in heart failure patients with low ejection fraction (≤35%) and elevated serum biomarkers (NTproBNP ≥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.
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