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Enrollment in Phase 1/2 heart failure trial completed.

CLEVELAND, Ohio, August. 12, 2014 -- Privately held Juvcntas Therapeutics, Inc., has completed the Phase 1 arm of the RETRO-HF clinical trial, and fully enrolled the Phase 2 arm that is evaluating the safety and preliminary clinical efficacy for retrograde infusion of JVS-100 in patients with heart failure.

JVS-100 is a non-viral plasmid that encodes for stromal cell-derived factor-1 (SDF-l). SDF-1 promotes cardiac function and tissue repair in patients who have had a heart attack and have heart failure years later through activation of the body's natural stem cell based regenerative repair processes.

Juventas recently reported interim results from its Phase 2 STOP-HF trial which demonstrated that JVS-100 delivered via endo-ventricular injection using the BioCardia Helical Infusion Catheter is safe and demonstrated clinically meaningful improvements in objective measures of cardiac function and biomarker parameters in patients with advanced heart failure.

Retrograde infusion is a minimally invasive technique in which a catheter is inserted through the venous system into a patient's coronary sinus. A balloon is then inflated in order to temporarily block blood flow in the vein of the heart so that the gene therapy can be infused directly into the heart. The technique employs commonly used balloons and catheters that are already approved for delivery of therapeutic agents to the heart.

The Phase 1 RETRO-HF trial is a 12-person open-label, dose-escalation study to evaluate the safety of performing retrograde infusion of JVS-100 dosed at 30 mg or 45 mg to patients with ischemic symptomatic heart failure. The procedure was safely performed in all 12 patients with 11 receiving the full JVS-100 dose. There were no unanticipated procedural or drug related adverse events. Upon meeting a one-week safety endpoint, an independent Data Safety Monitoring Committee (DSMC) allowed commencement of the Phase 2 RETRO-HF arm, a 60-patient randomized, double-blinded, placebo-controlled arm in which patients will receive JVS-100 at 30 mg or 45 mg or a placebo infusion.

The Phase 1 RETRO-HF trial is the first FDA-allowed study to demonstrate that retrograde infusion can be used to safely deliver gene therapy to the heart, the company said.


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Title Annotation:In The Clinic ...
Publication:Stem Cell Research News
Date:Sep 15, 2014
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