XenoTherapeutics to Start First Human Trial of Xeno-Skin™, a Novel Xenotransplantation Treatment for Severe Burns

FDA clears XenoTherapeutics’ IND application; Massachusetts General
Hospital designated as study center for first-in-human trials

BOSTON–(BUSINESS WIRE)–#FDAXenoTherapeutics,
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.

About Xeno-Skin™

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.

About XenoTherapeutics

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/

Contacts

Paul Sagan
LaVoieHealthScience
psagan@lavoiehealthscience.com
617-953-4779

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