The regenerative medicine company Juventas Therapeutics, which had already said it added Takeda Pharmaceuticals to its roster of investors, said this weekend it has raised enough money to take its treatments for heart failure and a severe form of peripheral artery disease through its latest round of clinical trials.
The $22.2 million investment will be used to complete a pair of phase 2 trials — one for chronic heart failure and the other for critical limb ischemia. Juventas’ stem cell treatment, JVS-100, uses a protein naturally produced by the heart (stromal cell-derived factor 1) that attracts stem cells to damaged tissue, keeps cells from dying and restores blood flow.
Data from the trials should be available by late next year, at which point Juventas would begin seeking a partner to commercialize their treatment and talk with the U.S. Food and Drug Administration about further trials, CEO Rahul Aras said. If all goes well with clinical trials, FDA approval could come as soon as 2016.
Its current funding round should last the business into 2014, he said.
Juventas’ competitors include everyone from Michigan startup Aastrom Biosciences to the Israeli public company Pluristem Therapeutics. They’re chasing a massive market. Some estimates indicate 1 million people suffer from critical limb ischemia in the United States, which translates to a $3 billion market opportunity for companies hoping to treat it.
Aras said Juventas’ approach will be slightly more affordable, much less complex and easier to use by physicians than many of the other options.
Juventas, based in Cleveland, Ohio, said its new $22.2 million series B investment round includes new investors Takeda, Venture Investors, the Cleveland Clinic’s Global Cardiovascular Innovation Center, Tri-State Growth Fund and Glengary, as well as some angel investors. All of its previous investors participated in this round, which was lead by Triathlon Medical Venture Partners and New Science Ventures.
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 said Takeda has come on only as a strategic investor without any additional rights to the product or specific terms.
Previous Juventas investors include Fletcher Spaght Ventures, Reservoir Venture Partners and Early Stage Partners. The company has raised $32 million totally (including $2 million in grant money). As part of the round, Venture Investors George Arida and Somu Subramaniam of New Science Ventures will join Juventas’ board of directors. Takeda has received observer status.
[Photo courtest of Flickr user Aussiegall]
