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JVS-100 delivers favorable interim results in STOP-HF trial
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According to interim results from the phase 2 STOP-HF trial, non-viral gene therapy with JVS-100, which expresses stromal cell-derived factor-1, improved cardiac function in patients with advanced HF more than a decade after MI.
The top-line data were reported at the Heart Failure Congress 2014.
At the time of the interim analysis, 93 patients with ischemic symptomatic cardiomyopathy and prior history of MI were randomly assigned in a 1:1:1 ratio to a single treatment of 15 mg or 30 mg JVS-100 (Juventas Therapeutics) or matching placebo. The study drug was administered directly to the heart via the BioCardia helical infusion catheter, according to a press release.
At 4 months, researchers reported dose-dependent improvements in echocardiographic parameters and biomarkers in the group assigned JVS-100.
A subpopulation of high-risk patients who received JVS-100 30 mg demonstrated improvements relative to placebo in left ventricular end-systolic volume (P<.05), LV end-diastolic volume (P=.11), LV ejection fraction (P=.23) and NT-proBNP levels (P=.12), according to the release.
“We’ve observed consistent dose-dependent responses across multiple objective measures that provide strong support for JVS-100 bioactivity in patients with a history of a heart attack [who] have progressed to symptomatic heart failure,” Marc Penn, MD, PhD, founder and chief medical officer for Juventas and director of cardiovascular research at Summa Health System, Akron, Ohio, stated in the release. Penn presented the interim data at the meeting.
Eugene Chung, MD, FACC, co-principal investigator and director of the advanced heart failure program at The Christ Hospital, said the interim results “warrant further clinical investigation of JVS-100 as a potential therapy for heart failure.”
“The structural improvements to the heart in STOP-HF patients observed at 4 months in response to JVS-100 are compelling, especially in patients with more advanced disease, who represent a high-risk heart failure population. The data suggests that the [stromal cell-derived factor-1] pathway induces left ventricular remodeling leading to trends of clinically meaningful volume reductions in patients,” Chung stated.
JVS-100 was well tolerated in all patients. The researchers reported no serious adverse effects associated with the therapy.
To date, JVS-100 has been safety delivered to more than 150 patients across multiple clinical trials, according to the press release.
Besides the 4-month follow-up, patients will be evaluated for objective and subjective clinical parameters at 12 months.
For more information:
Penn M. Late breaking trials 3. Presented at: Heart Failure Congress 2014; May 17-20, 2014; Athens, Greece.
Disclosure: Cardiology Today could not confirm disclosures at the time of publication.