- 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, Jan. 23, 2018 (GLOBE NEWSWIRE) -- Via OTC PR Wire -- 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.
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Source: Amarantus Bioscience Holdings, Inc.