Regenerative medicine startup Juventas Therapeutics has begun enrollment in a phase 2a trial of critical limb ischemia patients.
The Cleveland-based company, which recently secured an important investment from Takeda Pharmaceuticals, is planning to enroll 48 patients and complete enrollment early next year, CEO Rahul Aras said.
Juventas’ technology, called JVS-100, works by recruiting stem cells from the bone marrow to create new blood vessels. 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.
Critical limb ischemia (CLI) patients are enrolling at several U.S. hospitals, as well as three in India. CLI is a severe obstruction of the arteries that greatly decreases blood flow to the extremities.
About 3 million Americans suffer from the condition and the prognosis for many patients isn’t good: 25 percent mortality and 35 percent major amputation rates within a year of diagnosis, according to a statement from Juventas.
“CLI has become a very exciting clinical opportunity,” Aras said. “It’s becoming a growing area of interest for a number of biotech and pharma companies.”
Other companies pursuing CLI treatment include Aastrom Biosciences, Arteriocyte and Biomet.
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.
Among the top advantages of Juventas’ CLI therapy is its simplicity and cost-effectiveness, Aras said. Patients can be injected with the company’s therapeutic in an easy procedure at a physician office, and the approach doesn’t require bone marrow aspiration to obtain patients’ own stem cells or complex cell processing as some competing therapeutics do.
Juventas also has a phase 2 trial underway to investigate its therapy with heart failure patients.
The company is expected to shortly announce a series B round of investment, which includes the funding from Takeda, that totals around $20 million or $25 million.
[Photo from flickr user Horia Varlan]
