Amarantus Subsidiary Cutanogen Corporation Announces Issuance of US Patent 14/299,480 Covering ESS, Pigmented ESS and Gene
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.
https://ih.advfn.com/p.php?pid=nmona&article=76531951
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