Amarantus BioScience Holdings, Inc., a biotechnology company developing therapeutic and diagnostic product candidates in orphan indications and neurology, announced that the US Patent and Trademark Office (USPTO) issued US Patent No. 9,115,208 entitled, "Dopaminergic Neuronal Survival-Promoting Factors and Uses Thereof."
The patent covers additional intellectual property protection for MANF (mesencephalic-astrocyte-derived neurotrophic factor) protein therapy and cell therapy. The patent covers compositions of matter and methods of use related to the company's proprietary manufacturing process for synthetic MANF and its administration.
"The issuance of this key patent covering the proprietary compositions of matter and methods of use for MANF is very important to our intellectual property portfolio as we work towards the submission of a US investigational new drug application for MANF for the treatment of retinitis pigmentosa over the course of the next 12-18 months," said Gerald E. Commissiong, president & CEO of Amarantus.
"We continue to advance our pre-clinical research and development programs for MANF in other orphan ophthalmological indications and in Parkinson's disease and believe this patent is key to building a robust patent estate with the ultimate goal of realising MANF's full commercial potential in high value indications."
Native MANF is currently under development for the treatment of orphan ocular indications, including retinitis pigmentosa (RP). Amarantus recently received both US and European orphan drug designation for MANF for the treatment of RP. In addition to RP and Parkinson's disease, proof-of-concept preclinical models have also demonstrated that MANF proteins have the potential to treat a wide range of other conditions, including retinal artery occlusion, diabetes, ischemic heart disease and other chronic disorders.
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 injury or disease, via the unfolded protein response. 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, a naturally-occurring protein that reduces and prevents apoptosis (programmed cell death) in response to injury or disease, was discovered utilising Amarantus' proprietary PhenoGuard Protein Discovery Engine.
MANF's lead indication is retinitis pigmentosa, and additional indications including Parkinson's disease, diabetes and Wolfram's syndrome are currently being pursued. Further applications for MANF may include Alzheimer's disease, traumatic brain injury, myocardial infarction, antibiotic-induced ototoxicity and certain other rare orphan diseases currently under evaluation.