MANF Therapeutics Announces Publication of Positive Data for MANF in Stroke Animal Model in AAAS Journal Science Advances


NEW YORK, June 05, 2018 (GLOBE NEWSWIRE) -- Via OTC PR Wire -- MANF Therapeutics, Inc., a wholly-owned subsidiary of Amarantus Bioscience Holdings, Inc. (OTCPK:AMBS) in pre-clinical development advancing the orphan-drug designated therapeutic protein mesencephalic astrocyte-derived neurotrophic factor (MANF) as a disease-modifying treatment for orphan ophthalmological conditions, Glaucoma and Parkinson's disease, today announced the publication of a scientific article entitled "Poststroke delivery of MANF promotes functional recovery in rats" in the American Association for the Advancement of Science's (AAAS) open access journal Science Advances that describes positive effects of MANF in an animal model of post-stroke recovery. The work was published by researchers at the National Institute of Drug Abuse, the University of Helsinki and the Talinn University of Technology.

The data demonstrated that chronic delivery of human recombinant MANF (hrMANF) starting two days after stroke-like injury in the distal middle cerebral artery occlusion (dMCAo) rat model of ischemia-reperfusion injury resulted in statistically significant improvement in functional outcomes at each time points assessed (7 days, 14 days and 24 days post-treatment). MANF also demonstrated efficacy in animal models of other ischemia-reperfusion related conditions including retinal artery occlusion (RAO), and myocardial infarction (heart attack). MANF's emerging role as an immunomodulatory protein further supports its development as a potential treatment for stroke.

Stroke is the fifth leading cause of death in the United States, where it is estimated that over 800,000 people suffer from strokes annually. The global stroke treatment and diagnostics market is expected to reach $31 billion by 2021, according to Zion research. An effective therapy that could improve functional outcomes for patients in response to a stroke event is expected to generate over $3B in annual in sales. Based on the results of the study published in Sciences Advances, MANF has the potential to be developed as a treatment for post-stroke recovery.

MANF Therapeutics is preparing to restart IND-enabling development of MANF in 2018, initially in ophthalmology. MANF has therapeutic potential across multiple orphan ophthalmological conditions such as RAO and retinitis pigmentosa, where MANF has already received orphan drug designations from the FDA, as well as in larger indications such as Glaucoma, Parkinson's, Alzheimer's, diabetes and in cardiovascular disease, such as stroke and myocardial infarction. MANF Therapeutics is the front-runner and primary worldwide intellectual property (IP) holder for MANF-based therapies including protein therapy, gene therapy and cell therapy. The Company owns rights to composition of matter patents for MANF and owns, or has licenses to, method of use patents covering the use of MANF in ophthalmology, neurology and diabetes.


Stroke is the most common cause of adult disability in developed countries, largely because spontaneous recovery is often incomplete, and no pharmacological means to hasten the recovery exist. It was recently shown that mesencephalic astrocyte-derived neurotrophic factor (MANF) induces alternative or M2 activation of immune cells after retinal damage in both fruit fly and mouse and mediates retinal repair. Therefore, we set out to study whether poststroke MANF administration would enhance brain tissue repair and affect behavioral recovery of rats after cerebral ischemic injury. We used the distal middle cerebral artery occlusion (dMCAo) model of ischemia-reperfusion injury and administered MANF either as a recombinant protein or via adeno-associated viral (AAV) vector. We discovered that, when MANF was administered to the peri-infarct region 2 or 3 days after stroke, it promoted functional recovery of the animals without affecting the lesion volume. Further, AAV7-MANF treatment transiently increased the number of phagocytic macrophages in the subcortical peri-infarct regions. In addition, the analysis of knockout mice revealed the neuroprotective effects of endogenous MANF against ischemic injury, although endogenous MANF had no effect on immune cellrelated gene expression. The beneficial effect of MANF treatment on the reversal of stroke-induced behavioral deficits implies that MANF-based therapies could be used for the repair of brain tissue after stroke.

About MANF Therapeutics, Inc.

MANF (mesencephalic-astrocyte-derived neurotrophic factor) is believed to have broad potential because it is a naturally-occurring protein produced by the body to reduce/prevent apoptosis (cell death) in response to injury or disease, via the unfolded protein response. By administering exogenously produced MANF 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 retinitis pigmentosa, and additional indications including Parkinson's disease, diabetes and Wolfram's syndrome are envisioned. Further applications for MANF may include Alzheimer's disease, traumatic brain injury, myocardial infarction, antibiotic-induced ototoxicity and certain other orphan diseases.

In April 2017, Amarantus incorporated the wholly-owned subsidiary MANF Therapeutics, Inc. to focus on progressing preclinical and clinical development of MANF.

About Amarantus Bioscience Holdings, Inc.

Amarantus Bioscience Holdings (AMBS) is a JLABS alumnus biotechnology company developing treatments and diagnostics for diseases in the areas of neurology, regenerative medicine and orphan diseases through its subsidiaries. AMBS' wholly-owned subsidiary Elto Pharma, Inc. has development rights to eltoprazine, a Phase 2b-ready small molecule indicated for Parkinson's disease levodopa-induced dyskinesia, Alzheimer's aggression and adult attention deficit hyperactivity disorder, commonly known as ADHD. AMBS acquired the rights to the Engineered Skin Substitute program, a regenerative medicine-based approach for treating severe burns with full-thickness autologous skin grown in tissue culture that is being pursued by AMBS' wholly-owned subsidiary Cutanogen Corporation. AMBS' wholly-owned subsidiary MANF Therapeutics, Inc. owns key intellectual property rights and licenses from a number of prominent universities related to the development of the therapeutic protein known as mesencephalic astrocyte-derived neurotrophic factor ("MANF"). MANF Therapeutics, Inc. is developing MANF-based products as treatments for brain and ophthalmic disorders. MANF was discovered by the Company's Chief Scientific Officer John Commissiong, PhD. Dr. Commissiong discovered MANF from AMBS' proprietary discovery engine PhenoGuard. The Company also re-acquired rights to the Alzheimer's blood diagnostic LymPro Test , MSPrecise and NuroPro.

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Source: Amarantus Bioscience Holdings, Inc.