ALBUQUERQUE, N.M.--(BUSINESS WIRE)--Maas Biolab received United States Patent 7,446,093, European Union Patent 1,091,750 and Patents in India, Canada and New Zealand for its Mitogard® cyclosporin formulas. Mitogard® is designed for central nervous system delivery to treat neurodegenerative diseases, in particular amyotrophic lateral sclerosis (ALS). The patent covers the use of cyclosporin in DMSO formulations for neuroprotection and immunosuppression via cerebrospinal fluid (CSF), vascular, nasal and pulmonary delivery. The 19 European countries include Germany, France, the United Kingdom, Italy, Spain, Netherlands, Sweden and Switzerland.
Cyclosporin formulation is a compounding challenge, since it is water insoluble. The Maas Biolab solution is the cyclosporin-solubilizing excipient dimethyl sulfoxide (DMSO) that has low toxicity, low viscosity for easy syringeability, and chemical compatibility with the components of CSF pumps, ports and catheters. Water-free, full strength, ready-to-infuse Mitogard® has low viscosity and long-term stability within functioning pumps.
Cyclosporin does not cross the intact blood-brain barrier. Neurosurgeon and Maas Biolab CEO Marcus Keep, M.D., created Mitogard® to bypass the blood-brain barrier with direct CSF infusion of cyclosporin to get it into the spinal cords and brains of ALS patients. Cyclosporin is a powerful neuroprotectant in the G93A mouse model of ALS, slowing loss of motor neurons and paralysis. Long-term therapy with very low-dose CSF cyclosporin is not expected to be systemically immunosuppressive nor nephrotoxic. Maas Biolab has FDA Orphan Drug Designation for cyclosporin treating ALS, and is conducting NIH-funded animal toxicity trials of Mitogard®.
Maas Biolab, LLC
Maas Biolab is a private pharmaceutical company in Albuquerque, New Mexico, USA, developing Mitogard®, the only cyclosporin formula designed for CSF delivery, to treat amyotrophic lateral sclerosis (ALS) and other neurodegenerative diseases. (http://www.maasbiolab.com)