Amarantus Close to Finalizing ESS for Phase 2 Testing

Stephen L Kanaval  |

Amarantus BioScience (AMBS) develops treatments and tests for neurology, regenerative medicine and orphan diseases. Currently, the company is working on an Engineered Skin Substitute (ESS) that could be approved for three separate dermatological conditions. The tissue-engineered skin is created with the patient’s own skin and has epidermal and dermal components, and Amarantus believes ESS could be approved to treat:

  • Adult severe burns
  • Pediatric severe burns
  • Giant Congenital Melanocytic Nevi (GCMN)

Amarantus’ announcement confirmed that the growth and testing components if its confirmatory engineering run are nearing a technical transfer to Lonza Walkersville, Inc., a contract manufacturer, which will allow the biotech company to do a 10-patient trial on full thickness thermal burns covering over 50% of the body. This trial will be done in collaboration with the U.S. Army at Fort Sam Houston in Texas. "In October 2015, the Company decided to focus the majority of its available resources on the ESS program, due largely to the incredible need for this product in the marketplace - evidenced by the US Army's financial support and strong desire to open enrollment for the upcoming Phase 2 clinical study to treat U.S. soldiers who have been critically burned serving their country," said Gerald E. Commissiong, President & CEO of Amarantus. "Today's announcement marks a major milestone towards the opening of this study. We have demonstrated that we can grow ESS, a full thickness autologous human skin graft replacement product, in a cGMP environment. Moving forward, we will be laser-focused on making certain that this breakthrough cell therapy product candidate is well positioned from a regulatory perspective to gain marketing approval as quickly as possible."

In addition, just last week, Amarantus received a $3 million investment from an institutional investor. This capital gives the company sufficient spending to push the ESS program through execution phase. Under the terms of the agreement, the investor will be issued $3.3M worth of Series H Convertible Preferred Stock (including 10% original issue discount) from the Company and five year warrants exercisable for 13,200,000 shares of common stock at $0.40 per share.

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