JVS-100: Interim Phase II data

Juventas reported interim 4-month data from the double-blind, U.S. Phase II STOP-HF trial in 93 patients with symptomatic ischemic cardiomyopathy showing that a single injection of 30 mg JVS-100 non-significantly improved left ventricular end systolic volume (LVESV) (-11.1 vs. 1.8 mL, p=0.44), left ventricular end diastolic volume (LVEDV) (-12.6 vs. -1 mL, p=0.44) and 6MWD (p=0.15) vs. placebo. Juventas said there was a "marked placebo effect" at 4 months. In patients with a baseline LVESV greater than the median of 151 mL, the 30 mg dose of JVS-100 significantly improved LVESV by 30.9 mL vs. placebo (p<0.05) and non-significantly improved LVEDV by 23.6 mL (p=0.11), LVEF by 5.3% (p=0.23) and levels of N-terminal pro-brain natriuretic peptide (NT-proBNP) by 741.9 pg/mL (p=0.12) vs. placebo.

JVS-100 was well tolerated with no serious adverse events reported. The trial enrolled patients with a prior history of a heart attack and who years later developed symptomatic heart failure to receive a single injection of placebo or 15 or 30 mg JVS-100 delivered via endomyocardial injection with the Helical Infusion Catheter (HIC) system from BioCardia Inc. (San Carlos, Calif.). The patients were on stable medical therapy with an ejection fraction of <=40%, a Minnesota Living with Heart Failure (MLHF) questionnaire score of >20 points and a 6MWD of <400 meters. The company declined to disclose data for the 15 mg dose. Data were presented at the Heart Failure meeting in Athens. All patients will also be assessed at 12 months post-injection. Juventas expects to report 6MWD data next half and 12-month data in 1Q15. ...