On 28 October 2012 Amarantus BioSciences, Inc. released the results of an Independent Academic Study report demonstrating that MANF (mesencephalic astrocyte-derived neurotrophic factor), the Company's leading drug candidate for treatment for Parkinson's disease, when administered in the substantia nigra zona compacta (SNc) in the ventral midbrain, reduced the neurological deficits associated with Parkinson' disease. The accepted cause of Parkinson's disease is the death of 70-80% of the dopaminergic (DAergic) neurons in the SNc in the ventral midbrain. Previous animal model studies directed to Parkinson's disease have shown that protecting DAergic cell bodies in the SNc without increasing DAergic reinnervation in the striatum does not correct the neurological deficits association with Parkinson's disease.
Recent clinical trials of GDNF (glial cell line-derived neurotrophic factor), the model drug developed in the treatment of Parkinson's disease, indicates that while GDNF protects DAergic cell bodies in the SNc, it does not correct neurological deficits, which is necessary for a functional recovery in Parkinson's disease.
The Independent Study indicates that MANF, the Company's leading drug candidate, significantly reduces neurological deficits in a Parkinson's Disease model, while GDNF does not; thus, providing a firm basis for the continue investment in MANF development. The next step in MANF development is clinical studies utilizing a primate model. If those studies are positive, they will be incorporated in the toxicological data of an investigational new drug application package to the FDA to be submitted prior to starting a Phase I/II clinical trial for MANF in the treatment of Parkinson's disease.