Groundbreaking Avera-backed therapy cleared for clinical trials

A technology to treat peripheral vascular disease that was developed in a Sioux Falls lab and acquired by Avera has been approved for clinical trials.

The U.S. Food and Drug Administration is allowing phase one clinical trials of the Natural Vascular Scaffolding, or NVS, therapy developed by Alumend.

The NVS therapy combines balloon angioplasty with a pharmaceutical process and is the first combination product for vascular medicine to enter the FDA approval process.

“As a health care organization, we have two choices. We can either accept everyone else’s medical research or contribute to the knowledge base through our own research and see those discoveries put into practice at other sites,” said Dr. Dave Kapaska, CEO of Avera McKennan Hospital & University Health Center.

“Cutting-edge technology, rather than the status quo, is what sets leading health care institutions apart. When recruiting world-class physicians, we know that they will have a high degree of interest and curiosity, and this encourages us to take on further research opportunities.”

Now that the therapy is entering human clinical trials, it will be marketed through the name Alucent Medical Inc., an owned subsidiary of Alumend.

The technology has been in development for two decades. Alumend was a tenant years ago at the South Dakota Technology Business Center, now the Zeal Center for Entrepreneurship. It was acquired by Avera in 2011.

In the U.S., 8.5 million people are affected by peripheral vascular disease, with symptoms including severe leg pain, loss of mobility, numbness and weakness.

Balloon angioplasty is a proven medical therapy to open peripheral vascular arteries and other arteries that are blocked by plaque. But the procedure stretches the artery wall and requires a structure to keep it open so blood can flow. That involves placing stents, which often require retreatment, or drug-coated balloons, which might not keep the vessel open.

NVS represents a significant departure, according to Alucent. It’s a light-activated, chemical therapy designed to build natural scaffolding to keep the vessel open, possibly replacing the need for a stent.

“NVS has the potential to leap-frog current treatments for peripheral vascular disease,” said Dr. Myles Greenberg, CEO of Alucent.

While Alucent is licensed to test and market NVS to treat peripheral vascular disease, the therapy could have broader applications in other areas of the vascular system.

The therapy was developed by a team of Avera scientists led by Ron Utecht, chief scientific officer of Alumend and former professor of chemistry and biochemistry at SDSU.

“With Alumend’s development of NVS therapy through the invention of Dr. Ron Utecht, we saw very early on an opportunity to take basic science and bring about something very special,” Kapaska said.

“Alumend scientists have developed what we believe to be a very effective treatment for peripheral vascular disease – a potentially debilitating condition, which has marginal treatment options available. And there are possibilities for other applications of this chemistry, which the Alumend team will continue to work toward. This level of research takes considerable commitment because these discoveries don’t happen overnight. Yet we anticipate that this will benefit many lives, so it fits well within the Avera mission. Clinical trials of NVS have the potential to bring this novel product, developed right here in South Dakota, to a national stage.”

The phase one clinical trials will start this summer in Ohio, Pennsylvania and Tennessee. It is not being tested in Sioux Falls to avoid any conflicts of interest, although the hope is that Avera vascular surgeons will one day be able to offer it to patients.

“The promise of this novel therapy is extraordinary. We believe NVS could deliver a quantum advancement in the treatment of peripheral vascular disease, with the potential of totally eliminating vascular implants,” said James Corbett, who is chairman of the board of Alucent and has 30 years of experience in the medical device field. “There has never before been a cardiovascular application to the FDA for a new drug/device combination, and we feel there has never been an FDA application of this scope.”

The development is significant for the state’s growing biotech industry, said Scott Stern, commissioner of the Governor’s Office of Economic Development.

There are 5,800 people in 420 businesses employed in biotech-related jobs, and it has been an area of emphasis for economic developers.

“We’re excited that Alumend scientists continue their quest for more advancements with this novel light-activated chemical essential to NVS,” Stern said. “We commend Dr. Utecht’s work and the work of his entire team at Alumend.”

This post also featured on SiouxFalls.Business: https://siouxfalls.business/groundbreaking-avera-backed-therapy-cleared-for-clinical-trials/