Amarantus Announces cGMP Manufacturing Readiness for Its Engineered Skin Substitute (ESS) Program at Lonza Walkersville
Amarantus-sponsored training for Phase 2 severe burn trial completed with U.S. Army clinical site in late April
SAN FRANCISCO, June 7, 2016 /PRNewswire/ --
Amarantus BioScience Holdings, Inc. (OTCQB: AMBS), a biotechnology company focused on developing products for Regenerative Medicine, Neurology and Orphan Diseases, today announced that the current Good Manufacturing Practices (cGMP) manufacturing process for its Engineered Skin Substitute (ESS) program is now qualified at Lonza Walkersville, Inc., a premier contract manufacturer providing cell and tissue-based products for clinical development. ESS is a lab-grown, full-thickness skin graft made from a patient's own skin that is expanded ~100 fold in size to provide permanent wound coverage of large body surface areas, initially for use in treating life-threatening burns.
Reaching this milestone signifies that Amarantus is now positioned to supply ESS for its planned opening of the 10-patient, randomized, placebo-controlled, open-label Phase 2 clinical trial for the treatment of adult patients (ages 18-40 years old) with deep-partial and full-thickness thermal burns covering ≥50% of total body surface area (TBSA). The Company will open enrollment at the first site, the U.S. Army's Institute for Surgical Research (ISR) at Fort Sam Houston in Texas, under a Collaborative Research & Development Agreement (CRADA). Two additional civilian sites will be opened after ISR to accelerate enrollment of the study.
The Phase 2 clinical trial is designed to measure the safety and comparability of ESS with meshed split-thickness autografted skin, the current standard of care in the treatment of life-threatening severe burns. Amarantus will be reporting pre-defined data points on an ongoing basis throughout the trial on a patient-by-patient basis.
"cGMP-readiness at Lonza marks the first of several major milestones for the ESS program," said Gerald E. Commissiong, President & CEO of Amarantus. "Amarantus performed the sponsor portion of the site initiation process at ISR in late April, and the site is completing its final preparations to initiate the study. We expect the remaining items to be completed soon, at which point we will open enrollment for this breakthrough regenerative medicine cell therapy trial at the US Army's premier surgical research center."
About Engineered Skin Substitute (ESS)
Engineered Skin Substitute (ESS) is a tissue-engineered skin prepared from autologous (patient's own) skin cells. It is a combination of cultured epithelium with a collagen-fibroblast implant that produces a skin substitute that 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). The Company is evaluating opportunities to launch a pivotal clinical study with ESS in the areas of GCMN and pediatric severe burns once experience is gained in the adult severe burn setting.
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. 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. ESS is entering Phase 2 clinical studies under a CRADA agreement with the US Army. AMBS has development rights to eltoprazine, a Phase 2b-ready small molecule indicated for Parkinson's disease levodopa-induced dyskinesia, adult ADHD and Alzheimer's aggression, and owns the intellectual property rights to a therapeutic protein known as mesencephalic astrocyte-derived neurotrophic factor (MANF) and is developing MANF-based products as treatments for brain and ophthalmic disorders. MANF was discovered from the Company's proprietary discovery engine PhenoGuard. AMBS also received 80 million shares of Avant Diagnostics, Inc. via the sale of its wholly-owned subsidiary Amarantus Diagnostics, Inc.
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