Cleveland Clinic spinoff Juventas Therapeutics has successfully completed a phase 1 clinical trial of its regenerative medicine technology in heart failure patients.
Cleveland-based Juventas’ technology, JVS-100, works by recruiting stem cells from the bone marrow to create new blood vessels. In addition to heart failure patients, the company is investigating the treatment of patients suffering from critical limb ischemia (CLI), a severe obstruction of the arteries that reduces blood flow to hands, feet or legs.
“The focus of the trial was safety, and we have seen clear safety for the doses that we’ve evaluated for all the patients, but we’ve also seen some encouraging signs of efficacy,” CEO Rahul Aras said.
The company’s next step is to begin a phase 2 trial for CLI patients. Juventas has already received the go-ahead from the U.S. Food and Drug Administration to begin the trial. Aras also hopes to begin a phase 2 study of heart failure patients by the end of the year.
To fund the phase 2 trials, Aras is looking to raise a $25 million series B round of investment by the end of the year. The company is in talks with investors for the round, Aras said.
“After those trials, we’ll be in a good position to talk with strategic partners to take us through phase 3,” he said.
Juventas formed in 2007 under the name AcelleRX Therapeutics and has raised about $10.5 million in investment funding and grants. Existing investors include Early Stage Partners, Triathlon Medical Ventures and Blue Chip Venture Co., plus JumpStart and North Coast Angel Fund.
The JVS-100 technology was pioneered by Dr. Marc Penn, medical director of the Cleveland Clinic’s cardiac intensive care unit and Juventas’ chief science officer. It’s based on Stromal Cell-Derived Factor-1 (SDF-1), a naturally produced molecule that attempts to repair the heart immediately following a heart attack.