Cutanogen
Appoints Richard Kagan, MD as Chief Medical
Advisor
- Emeritus Chief of Staff of Shriners Burns Hospital -
Cincinnati to lead Pivotal Trial design
New York, NY
-- April 23, 2018 -- InvestorsHub
NewsWire --
Cutanogen
Corporation, an
orphan clinical-stage regenerative medicine wholly-owned subsidiary
of Amarantus Bioscience Holdings, Inc.
(OTCPK:
AMBS) advancing the autologous skin graft technology Engineered
Skin Substitute (ESS) for the treatment of pediatric severe burns
and other orphan dermatologic conditions, today announced the
appointment of Richard Kagan, MD to the role of Chief Medical
Advisor. In this role, Dr. Kagan will focus on assisting in the
design of the Cutanogen Pivotal clinical trial for ESS
in the treatment of catastrophic pediatric burn injuries, as well
as assisting Cutanogen's interim management team in
raising the capital necessary to prepare for the initiation of the
clinical program. Dr. Kagan brings with him over 35 years of
medical and investigational burn care experience to
Cutanogen, with the distinction of
having performed more than 50 surgical procedures using the
non-cGMP version of ESS developed at the Shriners Hospital in
Cincinnati, Ohio to treat life-threatening pediatric burn injuries
and giant congenital melanocytic nevi (GCMN).
"The ESS technology can
often times mean the difference between life and death for severely
burned patients, with the potential to provide dramatic, immediate
and long-term
outcomes for patients, while also potentially reducing the
immediate and long-term costs of care for this patient population,"
said Dr. Kagan, newly appointment Chief Medical Advisor at
Cutanogen. "With the recent
peer-reviewed publication of the final 16 patients treated with ESS
now in the public domain, and the tremendous advances seen in cell
and gene therapy in other therapeutic areas such as ophthalmology
and oncology, it is appropriate that a focused effort be undertaken
to bring this life-saving technology to market."
Prior to joining
Cutanogen, Dr. Kagan had retired from a
career as a tenured Professor of Surgery at the University of
Cincinnati College of Medicine as well as the Chief of Staff at the
Shriners Burn Hospital in Cincinnati, Ohio where the ESS technology
was clinically developed. Dr. Kagan is a past President of the
American Burn Association, and previously served as a member of the
American College of Surgeons Committee on Trauma and the President
of the American Association of Tissue Banks. Dr. Kagan serves on
the Editorial Board of the Journal of Burn Care &
Research and
has been an invited reviewer for the Journal of Trauma
and Acute Care Surgery, the Annals of
Surgery,
the Annals of Plastic Surgery, Burns
and
Surgery. Dr. Kagan has authored over 130 peer-reviewed
publications, 20 book chapters in medical textbooks, and has been
an investigator or co-investigator of over 35 research &
development grants.
"Dr. Kagan is an
authority in the field of pediatric burn care and has invaluable
expertise as one of the key surgeons with real-world experience
using the ESS technology to treat severely burned pediatric
patients," said Gerald Commissiong, interim-CEO at
Cutanogen. "Going forward we will be
focused on preparing for a pivotal clinical study in the treatment
of life-threatening pediatric severe burns. The next major steps
for this program are to re-establish the manufacturing
infrastructure and have Dr. Kagan work closely with
Amarantus' recently appointed Chief
Regulatory Advisor Dr. Brian Harvey to engage the FDA regarding how
to accelerate this life-saving treatment to the market for the
benefit of patients and their families."
About
Cutanogen Corporation
Engineered Skin Substitute
(ESS) is a tissue-engineered skin prepared from autologous
(patient's own) skin cells. It is a combination of cultured
epithelium and a collagen-dermal fibroblast implant that produces a
skin substitute which contains both epidermal and dermal
components. This model has been shown in preclinical studies to
generate a functional skin barrier. Most importantly, because ESS
is composed of a patient's own cells, it is less likely to be
rejected by the immune system of the patient, unlike porcine or
cadaver grafts in which immune system rejection is a possibility. A
non-GMP version ESS has been used in investigator-initiated and
compassionate-use clinical study settings in over 150 human
subjects, primarily pediatric patients, for the treatment of severe
burns up to 95% of total body surface area. The non-GMP version has
also been used in the treatment of two patients with Giant
Congenital Melanocytic Nevi (GCMN).
In July 2015,
Amarantus
acquired Lonza
Walkersville's wholly-owned subsidiary Cutanogen Corporation, the sole licensor
of intellectual property rights to ESS from Cincinnati's Shriners
Hospitals for Children and the University of Cincinnati.
Cutanogen
Corporation is a
wholly-owned subsidiary of Amarantus.
About
Amarantus Bioscience Holdings,
Inc.
Amarantus Bioscience Holdings (AMBS), a
JLABS alumnus company, is a biotechnology company developing
treatments and diagnostics for diseases in the areas of neurology,
regenerative medicine and orphan diseases through its subsidiaries.
AMBS' wholly-owned subsidiary Elto Pharma,
Inc. has
development rights to eltoprazine, a Phase 2b-ready small molecule
indicated for Parkinson's disease levodopa-induced dyskinesia,
Alzheimer's aggression and adult attention deficit hyperactivity
disorder, commonly known as ADHD. AMBS acquired the rights to the
Engineered Skin Substitute program, a regenerative medicine-based
approach for treating severe burns with full-thickness autologous
skin grown in tissue culture that is being pursued by AMBS'
wholly-owned subsidiary Cutanogen
Corporation.
AMBS' wholly-owned subsidiary MANF Therapeutics, Inc. owns key
intellectual property rights and licenses from a number of
prominent universities related to the development of the
therapeutic protein known as mesencephalic astrocyte-derived
neurotrophic factor ("MANF"). MANF Therapeutics,
Inc. is
developing MANF-based products as treatments for brain and
ophthalmic disorders. MANF was discovered by the Company's Chief
Scientific Officer John Commissiong, PhD. Dr. Commissiong discovered MANF from AMBS'
proprietary discovery engine PhenoGuard. The Company also re-acquired
rights to the Alzheimer's blood diagnostic LymPro Test , MSPrecise and NuroPro.
For further
information please visit www.Amarantus.com, or connect with the
Amarantus
on Facebook,LinkedIn,Twitterand
Google+.
Amarantus
Investor and Media
Contact:
Howard Gostfrand
American Capital Ventures,
Inc.
Office: 305-918-7000
Email: hg@amcapventures.com
Source: Amarantus Bioscience Holdings,
Inc.
