From April 2013-
"We plan to move forward on a number of fronts this year with MANF, leading potentially to one or more Investigational New Drug (IND) filings in 2014"
"We plan to move forward on a number of fronts this year with MANF, leading potentially to one or more Investigational New Drug (IND) filings in 2014," said Gerald E. Commissiong, President and Chief Executive Officer of Amarantus. "The pace and scope of activities outlined today reflect the unique properties of MANF, the positive results reported earlier this year in neuroprotective and neurorestorative animal models of Parkinson's disease and supportive data from the published literature."
The upcoming activities related to Amarantus' Parkinson's disease program include:
Create mammalian GMP production processes for MANF; the Company has sourced the expertise for these activities, and has started development of the supporting analytical and bioanalytical assays;
Form a partnership agreement in the third quarter of 2013 with a firm specializing in Convection-enhanced delivery (CED) of drugs to the brain;
Initiate non-human primate pharmacology studies in Parkinson's disease models in the second half of 2013 in order to establish an appropriate dosing regimen for human clinical studies;
Potentially evaluate MANF gene therapy based upon upcoming developments in the field of neurotrophic factors for Parkinson's disease, and the Company's current patent position whereby the Company owns exclusive rights to MANF gene therapy applications in all vector systems.
Additional planned activities are expected to include:
Conduct pharmacokinetic and pharmacodynamic (PK/PD) studies, with data available in the third quarter of 2013, to evaluate the biological properties of MANF when administered systemically, with data to be released as it becomes available;
Conduct pharmacology studies in traumatic brain injury, ischemic heart disease, diabetes and certain other animal models in the third quarter of 2013, with data to be released as it becomes available;
Evaluate MANF in a variety of animal models of orphan diseases in the third quarter of 2013 that represent significant market opportunities, and where there is limited or very limited competition;
Initiate MANF toxicology studies upon development of a master cell bank of MANF protein material as one of the final pre-IND steps;
File an IND in 2014."
"We plan to move forward on a number of fronts this year with MANF, leading potentially to one or more Investigational New Drug (IND) filings in 2014"
"We plan to move forward on a number of fronts this year with MANF, leading potentially to one or more Investigational New Drug (IND) filings in 2014," said Gerald E. Commissiong, President and Chief Executive Officer of Amarantus. "The pace and scope of activities outlined today reflect the unique properties of MANF, the positive results reported earlier this year in neuroprotective and neurorestorative animal models of Parkinson's disease and supportive data from the published literature."
The upcoming activities related to Amarantus' Parkinson's disease program include:
Create mammalian GMP production processes for MANF; the Company has sourced the expertise for these activities, and has started development of the supporting analytical and bioanalytical assays;
Form a partnership agreement in the third quarter of 2013 with a firm specializing in Convection-enhanced delivery (CED) of drugs to the brain;
Initiate non-human primate pharmacology studies in Parkinson's disease models in the second half of 2013 in order to establish an appropriate dosing regimen for human clinical studies;
Potentially evaluate MANF gene therapy based upon upcoming developments in the field of neurotrophic factors for Parkinson's disease, and the Company's current patent position whereby the Company owns exclusive rights to MANF gene therapy applications in all vector systems.
Additional planned activities are expected to include:
Conduct pharmacokinetic and pharmacodynamic (PK/PD) studies, with data available in the third quarter of 2013, to evaluate the biological properties of MANF when administered systemically, with data to be released as it becomes available;
Conduct pharmacology studies in traumatic brain injury, ischemic heart disease, diabetes and certain other animal models in the third quarter of 2013, with data to be released as it becomes available;
Evaluate MANF in a variety of animal models of orphan diseases in the third quarter of 2013 that represent significant market opportunities, and where there is limited or very limited competition;
Initiate MANF toxicology studies upon development of a master cell bank of MANF protein material as one of the final pre-IND steps;
File an IND in 2014."
