Stratatech Eyes Phase 3 Trial Of Regenerative Tissue For Burn Wounds

Xconomy Wisconsin — 

Stratatech moved closer this week to commercializing its skin-like tissue intended to coax patients with burn wounds to naturally regrow skin.

The Madison, WI-based company on Tuesday announced top-line results from a mid-stage clinical trial evaluating the safety and effectiveness of its “StrataGraft” skin tissue in patients with deep second-degree burns. Each patient received a graft of the company’s tissue at the site of a burn and an autograft—a graft of his or her own healthy skin taken from another part of the body—on another burn in order to compare results.

Stratatech was encouraged by the outcomes of the 28 patients who completed the trial. After 28 days, none of the wounds treated with Stratatech’s tissue required autografting. Within three months, the wounds were completely closed in 27 of the 28 patients; the 28th person had 85 percent skin regrowth at that time, the company said.

In addition, StrataGraft DNA couldn’t be detected in any of the patients after three months, which the company said shows the patients’ skin had been regenerated with their own cells. There were no signs of infection from the StrataGraft treatment, and those wound sites were generally left with a “smooth, supple appearance” that surpassed expectations and was “superior” to the cosmetic appearance of the autograft sites in some patients, Stratatech said.

“Patient outcomes in this study far exceeded our expectations, and are unprecedented in this patient population,” Stratatech CEO B. Lynn Allen-Hoffmann said in a press release.

The company intends to submit full results of the trial for publication in a medical journal, and it will apply to the FDA soon to start a Phase 3 study. If that trial is successful, the company would apply for approval to start selling the regenerative tissue to treat burn victims.

Severe burns that aren’t expected to heal on their own are usually treated with autografting, but that can potentially result in scarring and a risk of infection at the site of the healthy skin that was removed, among other drawbacks, Stratatech said.

The company designed a cellular therapeutic that imitates natural human skin and can be cryopreserved to extend its shelf life. The technology uses human keratinocyte progenitor cells and other biological materials that try to coax the patient’s body to begin regenerating its own skin.

Stratatech’s burn-healing product received orphan drug status from the FDA in 2012. The company is also developing an anti-microbial tissue meant to treat non-healing ulcers, including diabetic foot ulcers. That product has not yet entered clinical testing.

Founded in 2000, Stratatech has raised at least $3.6 million from investors, SEC documents show. It has won a number of grants over the years, the largest being a $47.2 million federal award in 2013.