Salt Lake City-based Alucent Medical Inc. reported it has been granted FDA approval to begin phase I trials of a combination drug/device intended to treat peripheral vascular disease (PVD). Called Natural Vascular Scaffolding (NVS), it is the first offering of privately held Alucent, which was formed to develop and market NVS.

Myles Greenberg, Alucent president and CEO, said he sees NVS as breaking new ground in treating patients with PVD, potentially reaching further than traditional devices used to treat the disease. While standard treatment for PVD includes balloon angioplasty, drug-coated stents and bioabsorbable stents among other options, NVS utilizes a light-activated drug delivered to the area. No temporary or permanent device is implanted, and the drug is intended to eliminate the need for retreatment by strengthening the area.

"It's really a biotechnology solution for what has traditionally been a device and mechanical application market," Greenberg told BioWorld Today. "We are intending to offer a product which can treat arterial disease and we think that we have the potential for it to be a market-leading superior approach to treating that disease."

Unlike the traditional devices, Alucent's novel drug is delivered via "a specialized vascular delivery catheter," explained Greenberg. At the same time, the drug is added to the area, an angioplasty balloon is inflated in the vessel, enlarging it as in traditional methods. "While we are doing that, we put a specialized light fiber into the balloon and shine the appropriate wavelength of [blue] light onto the area to activate the drug," he added.

NVS' drug action then cross-links collagen in the affected vessel thereby strengthening the area.

The combination therapy "naturally creates scaffolding in the vessel without the need for either temporary or permanent implantable hardware," said Greenberg. In addition, the collagen formed by "the action of the drug on the vessel causes it to retain its natural elasticity" compared with a potentially more rigid form of a stent.

SEEKING TO IMPROVE PVD CARE

NVS has the potential to reduce additional treatments and improve overall options for PVD patients, said Greenberg. "The treatments [for PVD] are not that great; they are not typically durable and they often require patients [to] have a lot of retreatments during the course of the disease," he explained.

In addition to an existing $2.5 billion market for PVD treatment – due to the estimated 9 million patients in the U.S. and 200 million worldwide who are diagnosed with PVD, and incidence as high as 20 percent in patients ages 65 to 70 – according to Greenberg, there may also be an unmet need in untreated patients. "We think that there may also be patients that suffer from the disease who are not currently getting interventions because the interventions that are out there are suboptimal," he said "So we think the market opportunity is quite large and the unmet need is quite large.

"It's key as a clinician to keep the patients at the top of your mind here, and they're a lot of patients who are out there suffering from limb ischemia and claudication, which are not good diseases [and] they are usually associated with other vascular diseases as well," said Greenberg.

NVS was developed under Avera Health, a five state health system which is guided in outlook by Benedictine and Presentations Sisters ministry. Avera's scientists were led by Ron Utecht, a former chemistry professor at South Dakota University, in the therapy's development. Utecht worked under the Alumend organization, a subsidiary of Avera Health, for several years in development of the drug/device therapy. Research was funded by Avera with an investment of more than $20 million.

After R&D was completed, Avera launched Alucent to specifically handle the therapy's next steps. "Now that it's ready for formal clinical development and commercialization, Avera Health decided that it made sense to spin out the vascular applications of it into a company that would be solely focused on that," said Greenberg.

Alucent has planned initial phase I studies of NVS, which will be held beginning this summer at three locations across the country. The company foresees moving NVS forward in successive studies at this time.

"We intend, obviously, to follow that [phase I study] with additional trials as the FDA will require and we'll need to prove that the product is safe and effective for the marketplace," said Greenberg.

No approvals have been gained outside the U.S., and no outside investors are involved, though Alucent may consider such investments in the future. "Our intention is at the right time to go out and probably broaden the investor base with others in addition to Avera who will continue to support the company but we've not definitively decided on the exact amount of money we'd be raising or when we'd be raising it," said Greenberg.