Maas Biolab SBIR Enters Phase II for Cyclosporin ALS Treatment
News Dec 04, 2008
Maas Biolab has advanced to Phase II of its Small Business Innovation Research (SBIR) grant “Intrathecal Cyclosporin for the Treatment of Amyotrophic Lateral Sclerosis (ALS).”
Jenny Karlsson, Ph.D., is Maas Director of Preclinical Development and Principal Investigator of the $2.1 million three-year grant from the National Institute of Neurological Disorders and Stroke (NINDS).
After successful completion of Phase I established initial Mitogard® stability and drug safety for the new intrathecal route for cyclosporin, the amount of $894,000 for year two was released by the National Institutes of Health (NIH).
“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 II 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.
The cholesterol-lowering drugs called statins have demonstrated substantial benefits in reducing the risk of heart attacks and strokes caused by blood clots (ischemic strokes) in at-risk patients. Since statins are associated with a low risk of side effects, the benefits of taking them outweigh the risks, according to a scientific statement from the American Heart Association that reviewed multiple studies evaluating the safety and potential side effects of these drugs.READ MORE
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