A phase 1 clinical trial has shown that Juventas Therapeutics‘ regenerative medicine therapy provides clinical benefit to heart failure patients.
Phase 1 trials generally focus on safety, so the indication of clinical benefit is an encouraging sign for Cleveland-based Juventas. “We are excited to see strong signs of efficacy across multiple clinical parameters,” CEO Rahul Aras said.
The company’s technology, JVS-100, works by recruiting stem cells from the bone marrow to create new blood vessels and prevent ongoing cell death at the site of a patient’s injury.
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Four months after treatment, heart failure patients involved in the study showed improvements in their performance in a walking test, as well as better scores on the Minnesota Living with Heart Failure Questionnaire, according to a statement from the company.
Juventas recently presented data from the 17-patient trial at the annual meeting of the American Society of Gene & Cell Therapy.
Juventas has already received the go-ahead from the U.S. Food and Drug Administration to begin a phase 2 trial with critical limb ischemia patients, which it expects to start later this year. The company also hopes to begin a phase 2 study of heart failure patients by early next year year.
Heart failure affects approximately 5 million Americans.