“The first year’s results show Mitogard® intrathecal safety in the therapeutic range, and we look forward with excitement to the second year’s more in-depth toxicology testing,” says Dr. Karlsson.
Phase 2 will complete the preclinical stability, toxicology and pharmacokinetics over the next two years to enable the first human clinical trials for Maas Biolab’s Mitogard® intrathecal cyclosporin formula. The Veterans Administration Clinical Research Pharmacy Coordinating Center, Albuquerque, N.M., performs stability testing. Northern Biomedical Research, Muskegon, Mich., conducts the intrathecal testing.
Thirty thousand Americans have ALS. Progressive loss of motor neurons causes paralysis and death within three years. Injections of cyclosporin into the CSF bypass the blood brain barrier and extend survival in the SOD1 G93A transgenic ALS mouse at low non-immunosuppressive doses.
Maas Biolab, LLC
Maas Biolab is a private pharmaceutical company in Albuquerque, N.M., USA developing Mitogard®, the only cyclosporin formula designed for CSF delivery, to treat ALS. Maas Biolab holds FDA Orphan Drug Designation for cyclosporin to treat ALS and world patents for cyclosporin neuroprotection against chronic neurological diseases. www.maasbiolab.com
NeuroVive Pharmaceutical AB is a partner producing NeuroSTAT®, a patented intravenous cyclosporin formula to treat traumatic brain injury. www.neurovive.com
The project described is supported by Grant Number U44NS059084 from the NINDS. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Neurological Disorders and Stroke or the National Institutes of Health.