Retired American Burn Association President Dr. David Ahrenholz to Present on Engineered Skin Substitute (ESS) at the Vatican's Third International Conference on the Progress of Regenerative Medicine and its Cultural Impact
SAN FRANCISCO, April 25, 2016 /PRNewswire/ --
Amarantus BioScience Holdings, Inc. (OTCQX:AMBS), a biotechnology company developing products in Regenerative Medicine, Neurology and Orphan diseases, today announced that Retired American Burn Association President Dr. David Ahrenholz has been selected to present Engineered Skin Substitute for the treatment of life threatening severe burns at The Third International Conference on the Progress of Regenerative Medicine and its Cultural Impact being held April 28-30, 2016 at the Vatican. Dr. Ahrenholz will be presenting on April 30, 2016 during the "Rebuilding and Restoring the Human Body" session beginning at 10:10am local time.
"I am pleased to bring to light the breakthrough ESS program that will be re-entering clinical development very shortly following an almost 6-year hiatus," said Dr. Ahrenholz. "I firmly believe that if ESS is approved by regulatory authorities, it has the potential to dramatically reduce the mortality rate and become the standard of care in the treatment of life threatening burns. For the pediatric population, not only could ESS save lives, but also significantly reduce the need for additional revision surgeries over time as patients grow - where the current standard of care requires frequent, extended-stay return to the hospital for painful additional skin grafting."
Dr. Ahrenholz previously provided a video interview on the potential of ESS for treatment of severe burns that is available online at: http://www.amarantus.com/news/videos .
Amarantus is preparing to initiate a 10-patient Phase 2 clinical trial with ESS under a Collaborative Research & Development Agreement (CRADA) with the U.S. Army's Institute for Surgical Research (ISR) at Fort Sam Houston in Texas. Two additional civilian sites will be opened to accelerate enrollment of the study. A link to an article featuring the pending Phase 2 clinical trial recently featured in Military Times magazine is available at: http://www.militarytimes.com/story/military/benefits/health-care/2015/10/11/bio-engineering-skin-treat-severe-burns/73511584/ .
ESS has already received orphan drug designation from the U.S. FDA for the treatment of severe burns covering over 50% of the body. Amarantus is planning three distinct orphan clinical development programs for ESS, all of which have the opportunity to gain rapid market approval in various dermatologic conditions:
- Adult severe burns: Initiating a 10-patient Phase 2 clinical development program with US Army study under CRADA at ISR and two additional leading civilian burn centers;
- Pediatric severe burns: Evaluating Phase 3 development program designs with leading pediatric burn center(s) in the United States;
- Giant Congenital Melanocytic Nevi (GCMN): Evaluating pivotal development program designs with leading dermatology center(s) in the United States.
About Amarantus BioScience Holdings, Inc.
Amarantus BioScience Holdings (OTCQX:AMBS) is a biotechnology company developing treatments and diagnostics for diseases in the areas of Neurology, Regenerative Medicine and Orphan diseases. The Company has an exclusive worldwide license to intellectual property rights associated with Engineered Skin Substitute (ESS), an autologous full thickness skin replacement product in development for the treatment of adult severe burns, currently preparing to enter Phase 2 clinical studies. In parallel, the Company is evaluating human clinical data from previously conducted studies in pediatric severe burns and Congenital Giant Hairy Nevus to support clinical development expansion into those areas. ESS has achieved Orphan Drug Designation (ODD) in the area of severe burns, and is seeking ODD status for additional serious dermatologic indications. AMBS also has development rights to eltoprazine, a small molecule currently in clinical development for Parkinson's disease levodopa-induced dyskinesia, an orphan disorder, with the potential to expand into adult ADHD and Alzheimer's aggression. AMBS owns the intellectual property rights to a therapeutic protein known as mesencephalic astrocyte-derived neurotrophic factor (MANF) and is developing MANF as a treatment for orphan ophthalmic disorders, initially in retinitis pigmentosa (RP) and retinal artery occlusion (RAO). AMBS also owns the technology platform that led to MANF's discovery (PhenoGuard™), and which can be used to identify novel neurotrophic factors.
AMBS' Diagnostics division owns the rights to MSPrecise®, a proprietary next-generation DNA sequencing-based test for identifying patients with relapsing-remitting multiple sclerosis at first clinical presentation, has an exclusive worldwide license to the Lymphocyte Proliferation test (LymPro Test®) for Alzheimer's disease, (developed by Prof. Thomas Arendt, Ph.D., from the University of Leipzig), and owns intellectual property for the diagnosis of Parkinson's disease (NuroPro).
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