FDA clears XenoTherapeutics’ IND application; Massachusetts General Hospital designated as study center for first-in-human trials
BOSTON–(BUSINESS WIRE)–December 7, 2018–
XenoTherapeutics, a life science company whose mission is to solve the global shortage of organs and tissues for transplants, announced today that the U.S. Food and Drug Administration has cleared the company’s Investigational New Drug application (IND #18914) allowing clinical studies of Xeno-Skin™ to be initiated. Xeno-Skin is a first-of-its-kind xenotransplantation product, designed to provide a safe temporary coverage mechanism for patients with severe burn wounds. The company is in active preparations to enroll patients for a first-in-human clinical study of Xeno-Skin at Massachusetts General Hospital (MGH) by the end of 2018.
“Xeno-Skin is the first non-human organ transplant cleared by the FDA for investigational use,” said Paul Holzer, CEO and Co-founder of XenoTherapeutics. “Our goal with this initial product is to advance the science of xenotransplantation for practical therapies that can benefit patients around the globe while addressing a critically unmet need for burns; but equally as important, paving the way for future organ transplant solutions.”
Burn patients need an immediate treatment option to support them through the acute phase of their injuries. During this critical period, patients with severe burns are at risk due to the disrupted skin barrier, which leads to infection from opportunistic pathogens, impairment of immune response, as well as 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.
Xeno-Skin is a live cell xenotransplantation product containing epidermal and dermal cell layers, providing temporary wound coverage during this critical period, immediately post-burn. It is intended to serve as a replacement or a complement to deceased donor allograft, the current standard of care for burn treatment. However, unlike the limited quantity of lifesaving human graft material available, Xeno-Skin is intended to be mass-produced, stored, and rapidly shipped when needed. XenoTherapeutics is being assisted in its efforts by Cummings School of Veterinary Medicine at Tufts University.
“Demonstrating the safety and efficacy of this novel solution has the potential to address an acute gap in emergency burn treatment options,” said Jeremy Goverman, MD, FACS of Massachusetts General Hospital and Principal Investigator of the Xeno-Skin clinical trial. “Xeno-Skin could provide an early first-line treatment in managing severe burns that could potentially be used to provide an extended period of temporary burn wound coverage.”
“Ultimately, having a temporary skin barrier solution that can be cryopreserved and shipped globally for immediate use or storage will help increase emergency preparedness for unexpected catastrophic events and fill current shortages experienced far too frequently around the world today,” said Curtis Cetrulo, M.D., FACS, FAAP and Chief Medical Officer of XenoTherapeutics, who is also an MGH transplant surgeon.
“Xenotransplantation of living, porcine skin grafts could be a promising alternative for the treatment of burns,” said David H. Sachs, MD, Professor of Surgery at Columbia University Irving Medical Center, Professor of Surgery Emeritus, Harvard Medical School, and founder of the MGH Transplantation Biology Research Center Laboratories. “This alternative source could avoid some of the disadvantages associated with the use of deceased-donor allogeneic skin, including high cost, limited of availability and the risk of human pathogen transmission.”
“We’re excited to see the potential global impact that Xeno-Skin may have on patients impacted by severe burns,” said Laurie Halloran, President and CEO at Halloran Consulting Group, a life science consulting firm and partner to XenoTherapeutics on their strategic development plan and IND application submission for Xeno-Skin. “We work with scientists and business founders to take their ideas and research to the forefront of medical innovation and we’re thrilled to have played a role in helping Xeno-Skin advance into clinical trials.”
“The odds are in life that you may never be burned,” said Ed Kelly, General Secretary and Treasurer of the International Association of Fire Fighters. “But if you or a loved one were, you’d want to have the best science and technology that could help treat burn victims effectively and have that technology broadly available.”
“This science has the potential to save a child, a sibling, a parent, or a loved one,” said Joy Greene, burn survivor and burn patient advocate. “People like me, who had lost all hope – full of fear and full of pain. And who never thought they’d see the life they had again. Try to understand the long-term good of this science.”
Background Information on Burn Injuries Worldwide
The World Health Organization (WHO) reports that globally, burns are responsible for approximately 180,000 deaths annually, while the average incidence in the United States is nearly 18,000 partial- and full-thickness burns each year (World Health Organization, 2018). The current clinical standard of obtaining a temporary coverage is human cadaver allograft (HCA). Unfortunately, given the inherent logistical and supply constraints, as well as infections agent concerns, the availability of HCA is severely limited. Thus, there remains a need for a high quality, temporary method of coverage for burns that would heal most effectively if treated with a live-cell product that can complete the critical vascularization process.
Xeno-Skin is a biologically active, split-thickness, xenotransplantation skin product consisting of dermal and epidermal tissue layers containing vital, non-terminally sterilized porcine cells derived from specialized, genetically engineered, Designated Pathogen Free (DPF), source animals (alpha 1,3 galactosyltransferase knockout [GalT-KO]). 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.
XenoTherapeutics is dedicated to advancing the science and clinical use of xenotransplantation. The company has developed the first non-human organ transplant solution that has the potential to advance the science of xenotransplantation and help address the critically unmet need for organs and tissues for patients around the globe. XenoTherapeutics supports and adheres to the provisions of all applicable laws, regulations, and policies governing the ethical treatment of animals, including the Animal Welfare Act and Public Health Service Policy of Humane Care and Use of Laboratory Animals.
For more information, please visit: https://www.xenotherapeutics.org/