Introduction From Steve Byer
"This is one of the new protocols being developed for the treatment of ALS that I referred to in an earlier newsletter. While only in Phase 2 (dosage/efficacy), having succeeded in Phase 1 (safety), the intrathecal usage of Cyclosporin is, in my opinion, one of the leading opportunities to have come to the forefront in the past several years. Whereas Cyclosporin has been considered for ALS since the early 1980’s and was trialed by Dr Stanley Appel in 1988 as an oral medication, it is only since its use as an intrathecally-delivered medication (injected into the spinal cord) that its promise seems more relevant. I intend to meet with Maas Biolab in December at their facility in Albuquerque to gain more information, having first become interested in their approach to Cyclosporin A through intrathecal injection (Mitogard) when meeting with them at the MNDA Symposium in Toronto in November 2007."
Maas Biolab Enters Phase 2 For Cyclosporin ALS Treatment
Maas Biolab has advanced to Phase 2 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 1 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 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.
http://www.maasbiolab.com
NeuroVive Pharmaceutical AB is a partner producing
NeuroSTAT®, a patented intravenous cyclosporin formula to
treat traumatic brain injury.
http://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.
