Juventas Therapeutics, a regenerative medicine company, has competed a Phase I clinical trial evaluating the safety and efficacy of JVS-100, an encoder of Stromal-cell Derived Factor (SDF-1) that can promote tissue repair through the recruitment of endogenous stem cells, in heart failure (HF) patients.
The Cleveland-based company enrolled 17 NYHA Class III HF patients with left ventricular ejection fractions less than 40 percent and an average time from MI of 7.3 years and evaluated three JVS-100 doses: 5 mg, 15 mg and 30 mg in three separate cohorts.
The researchers used major adverse cardiac event (MACE) rates at 30 days as the study’s primary endpoint. Researchers presented preliminary results from the clinical trial at this year’s American College of Cardiology scientific sessions in New Orleans and reported that the four-month safety data were collected and the primary endpoint was met without adverse events related to the drug.
At four months, the researchers said that patients are demonstrating “dose-dependent improvements in all clinical parameters with clinically relevant improvements compared to baseline in quality of life score and six-minute walk distance.” One month after dosing patients in cohort three--30 mg dose--showed similar improvements in quality of life and six-minute walk time and some patients improved a full NYHA class.
"The clinical responses observed are exciting and warrant further investigation of JVS-100 for treatment of heart failure in a Phase II clinical trial,” said Douglas Losordo, MD, principal investigator.
In addition to these preliminary results, Juventas said that it has also received FDA approval for a Phase II trial to evaluate the safety of JVS-100 to treat critical limb ischemia patients.
The company said that the complete results of the Phase I clinical trial will be presented at this year’s American Society for Gene & Cell Therapy meeting May 19 in Seattle.