Regenerative medicine company Juventas Therapeutics Inc. has received regulatory approval to begin a Phase 2 clinical trial of critical limb ischemia patients.
Juventas hopes to begin enrolling patients in a trial of its regenerative medicine technology beginning in the second quarter, and complete enrollment by the end of the year, CEO Rahul Aras said.
Critical limb ischemia (CLI) is a severe obstruction of the arteries that decreases blood flow to the extremities and can result in amputation. Juventas is able to forego a Phase 1 trial for CLI patients because it’ll leverage its clinical data from a Phase 1 trial of heart failure patients. The heart failure clinical trial began enrollment in April.
Juventas’ technology, called JVS-100, is based on a growth factor that in adults recruits stem cells from the bone marrow to create new blood vessels. The factor acts as a “beacon,” recruiting stem cells to repair a damaged organ, Aras said.
The company’s technology was pioneered by Dr. Marc Penn, medical director of the Cleveland Clinic’s cardiac intensive care unit. Penn is Juventas’ chief medical officer. Aras was previously an executive with Cleveland Clinic Innovations, the health system’s technology transfer unit.
Aside from the trial, much of Juventas’ focus in 2011 will be on fundraising. The company will need between $25 million and $30 million to fund the CLI and heart-failure trials, Aras said.
So far, four-employee Juventas has raised about $10 million through angel funding, venture capital and grants since its 2007 inception, Aras said. Investors include Triathlon Medical Ventures and Blue Chip Venture Co., both in Cincinnati, plus JumpStart Inc. and North Coast Angel Fund.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Aras projected 2015 or 2016 for when Juventas would get its first product on the market. It’s not yet clear whether the company will look to first market JVS-100 to CLI or heart failure patients, he said.
