Amarantus BioScience Holdings, Inc., a biotechnology company focused on developing products for regenerative medicine, neurology and orphan diseases, announced that has received an Intent to Grant a Patent notice from the European patent officer for the Mesencephalilc Astrocyte-derived Neurotrophic Factor (MANF) method of use patent application entitled "Method of Treatment for Retinal Disorders". Amarantus expects the patent to issue later in 2016, adding additional key elements to our strong barrier-to-entry strategy for this potentially breakthrough technology targeting rare ophthalmological disorders.
Recent key achievements in the MANF development programme include receipt of orphan drug designation from the US FDA for the treatment of retinitis pigmentosa; receipt of orphan drug designation from the US FDA for the treatment of retinal artery occlusion; receipt of orphan drug designation from the EMA for the treatment of retinitis pigmentosa; submission of request for rare paediatric disease designation in the treatment of retinitis pigmentosa;initiated process development with Catalent for manufacturing MANF protein in support of future first-in-man clinical studies.
"We are excited to see the continued progress for the company's intellectual property strategy to protect our innovative technology for ophthalmological disorders," said Gerald E. Commissiong, president & CEO of Amarantus. "MANF and CDNF define a unique family of proteins that act to protect cells and tissues from stress, via a mechanism that is of great interest to the scientific community. As a result of emerging scientific discoveries in the field, MANF's compelling biology, and solid progress on the regulatory front, we have begun to see a clear increase in business development interest around MANF."
In parallel, Amarantus has retained Wallachbeth Capital to evaluate strategic options for the MANF gene therapy programme which may expand the potential areas for therapeutic application.
MANF is believed to have broad potential because it is a naturally-occurring protein produced by the body for the purpose of reducing and preventing apoptosis (cell death) in response to stress from injury or disease, making it an attractive potential candidate for treating RP. By manufacturing MANF and administering it to the body, Amarantus is seeking to use a regenerative medicine approach to assist the body with higher quantities of MANF when needed. Amarantus is the front-runner and primary holder of intellectual property around MANF, and is initially focusing on the development of MANF-based protein therapeutics.
MANF's lead indication is RP, and additional indications including central retinal artery occlusion, Parkinson's disease, diabetes and Wolfram's syndrome are currently being evaluated. Further applications for MANF may include Alzheimer's disease, traumatic brain injury, myocardial infarction, antibiotic-induced ototoxicity and certain other rare orphan diseases currently being considered.