Amarantus Announces cGMP Manufacturing Readiness f
Post# of 30069
Posted On: 06/07/2016 9:28:16 AM
Amarantus Announces cGMP Manufacturing Readiness for Its Engineered Skin Substitute (ESS) Program at Lonza Walkersville
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JUNE 07, 2016
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."
Download as PDF
JUNE 07, 2016
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."
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