Amarantus
Subsidiary
Cutanogen Corporation
Announces Issuance of US
Patent 14/299,480
Covering ESS, Pigmented ESS and Gene
Therapy-Modified ESS
- Patent Issuance Opens Potential to genetically modify cells
used to produce ESS
Peer-Reviewed publication demonstrates improved donor cosmetic skin
color matching of melanocytes-implanted ESS vs. original ESS in
animals
Rare Pediatric Disease Designation and Regenerative Medicine
Advanced Therapy designations provide regulatory framework to
advance ESS' path to market
San Francisco, CA
-- January 23, 2018 -- InvestorsHub NewsWire
-- Amarantus
Bioscience Holdings, Inc. (OTCPK:
AMBS), a US-based biotechnology holding company with
wholly-owned subsidiaries developing first-in-class orphan
neurologic, regenerative medicine and ophthalmic therapies, today
announced that its wholly-owned subsidiary Cutanogen Corporation
was issued United States patent 14/299,480 entitled
"Surgical device for skin therapy or testing"
covering materials and methods for producing Engineered Skin
Substitute for the treatment of skin-related conditions and/or
testing of potential treatments for skin-related conditions. The
patent includes claims relating to the method of manufacturing ESS,
methods for adding melanocytes to ESS to improve skin
color-matching for patients, and methods for genetically-modifying
ESS. The patent extends coverage for ESS through 2022, not
including potential patent extensions upon product approval. Once
approved, ESS is eligible for 12 years of market exclusivity under
the Biologics Price Competition and Innovation Act
(BPCIA).
"The issuance of this patent
in the United States solidifies Cutanogen's leading position in the
field of cell therapy for autologous, full-thickness skin
products," said Gerald Commissiong, CEO of Cutanogen's parent
company Amarantus. "Cutanogen is now refocusing the ESS program
towards pediatric severe burns, opening the potential for the
company to utilize the Rare Pediatric Disease Designation (RPDD)
pathway that has several potential advantages, including a
potential Priority Review Voucher. In addition, the 21st Century
Cures Act's recently created Regenerative Medicine Advanced Therapy
(RMAT) designation provides Cutanogen with additional avenues to
accelerate ESS' path to market. Burn physicians worldwide are eager
to see ESS come to market to treat the most challenging,
life-threatening burn injuries."
Cutanogen Corporation is
currently in the planning phases for the pivotal development of ESS
for the treatment of life-threatening pediatric severe burns based
upon data published in the peer-reviewed medical Journal of
Burn Care & Research entitled "Randomized, Paired-Site
Comparison of Autologous Engineered Skin Substitutes and
Split-Thickness Skin Graft for Closure of Extensive, Full-Thickness
Burns".
The recent peer-reviewed
article in the scientific journal Pigment Cell
& Melanoma Research entitled
"Restoration of cutaneous pigmentation by transplantation
to mice of isogeneic human melanocytes in dermalepidermal
engineered skin substitutes" demonstrates the potential to
safely add melanocytes to ESS to produce pigmented skin that is
similar in color to original donor skin pigment. Pigmented ESS
would potentially improve outcomes for burn victims, as well as
significantly expand the market opportunity for ESS into the
$130B
global cosmetic skin care market.
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 with 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 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
Shriner's Hospital 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) 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 ADHD. AMBS acquired the rights to
the Engineered Skin Substitute program (ESS), 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.
AMBS also owns approximately 80 million shares of Avant
Diagnostics, Inc. via the sale of its wholly-owned subsidiary
Amarantus Diagnostics, Inc. that occurred in May
2016.
For further information
please visit www.Amarantus.com,
or connect with the Amarantus on Facebook, LinkedIn, Twitter and Google+.
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Amarantus
Investor and Media Contact:
Ascendant Partners,
LLC
Richard
Galterio
+1-732-410-9810
rich@ascendantpartnersllc.com
Source: Amarantus Bioscience
Holdings, Inc.