Earlier this week, the U.S. Food and Drug Administration cleared the company’s Investigational New Drug Application to allow the company to initiate clinical studies with Xeno-Skin, a product designed to provide help for patients who have suffered from significant burns.
When the term pigskin is mentioned, thoughts immediately go to football, or to pork cracklins’, a gastronomical delight in the American south. But for Boston-based XenoTherapeutics, pigskin means a potential treatment option for burn victims.
Earlier this week, the U.S. Food and Drug Administration cleared the company’s Investigational New Drug Application to allow the company to initiate clinical studies with Xeno-Skin, a product designed to provide help for patients who have suffered from significant burns. Xeno-Skin is a first-of-its-kind “xenotransplantation product,” the company said. XenoTherapeutics is planning to enroll patients in the first human trials with Xeno-Skin at Massachusetts General Hospital. The company hopes to have its first patient by the end of 2018.
Xeno-Skin is the first non-human organ transplant cleared by the FDA for investigational use, XenoTherapeutics Chief Executive Officer Paul Holzer said. The goal with the product, Holzer said, is to “advance the science of xenotransplantation for practical therapies” while addressing a “critically unmet need for burns.” Equally as important, Holzer said, is this trial can pave the way for “future organ transplant solutions.”
The current clinical standard of care is using human cadaver allograft. However, because of logistical and supply constraints, as well as infections agent concerns, the availability of this type of donor skin is severely limited. XenoTherapeutics’ Xeno-Skin uses porcine skin cells that have been genetically engineered to be designated pathogen free. Xeno-Skin is a topically applied, xenotransplantation product with the potential to provide a safe temporary coverage mechanism for patients with severe and extensive, deep partial and full thickness burn wounds. Unlike human graft material, Xeno-Skin can be mass-produced and stored for when needed.
In its announcement about the clinical trial, XenoTherapeutics said burn patients need immediate treatment options that will support them through the “acute phase” of their injuries. During this time period, the company said patients who have suffered severe burns are at risk to other complications due to the disrupted skin barrier. Those complications include infection from pathogens, impairment of the immune response and fluid loss from the burn site.
“These factors contribute to electrolyte, temperature and pH imbalances that if not addressed, ultimately contribute to organ failure, and unfortunately death,” the company said.
Curtis Cetrulo, chief medical officer for XenoTherapeutics, said having a skin barrier solution that can be cryopreserved and shipped globally “will help increase emergency preparedness for unexpected catastrophic events and fill current shortages experienced far too frequently around the world today.”
According to the World Health Organization, burns are responsible for approximately 180,000 deaths annually. In the United States, there are approximately 18,000 partial- and full-thickness burns each year.
