KRIBIOLISA™ Dirucotide (MBP8298) ELISA

2 - 8°C

Quantitative immunoassay for Dirucotide

Introduction:
Dirucotide (MBP8298) was developed by two research scientists (Dr. Kenneth G. Warren & Ingrid Catz at the
University of Alberta) for the treatment of Multiple Sclerosis (MS). Dirucotide is a synthetic peptide that
consists of 17 amino acids linked in a sequence identical to that of a portion of human myelin basic protein
(MBP). The drug is exclusively licensed by BioMS Medical Corp., a Canadian-based biotechnology company.
BioMS Medical received clearance from the Food & Drug Administration (FDA) to initiate a phase III clinical
trial, named MAESTRO-03, for secondary progressive MS patients in January 2007. An additional Phase III
clinical trial for dirucotide, MAESTRO-01, is being undertaken in Canada and Europe. In September 2008, the
drug was granted FDA fast-track for approval. On July 2009, a statement was released, stating "BioMS
Medical Corp. today announced that Dirucotide did not meet the primary endpoint of delaying disease
progression, as measured by the Expanded Disability Status Scale (EDSS), during the two-year MAESTRO01 Phase III trial in patients with secondary progressive multiple sclerosis (SPMS). In addition, there were no
statistically significant differences between Dirucotide and placebo on the secondary endpoints of the study",
this means that the MAESTRO-02 and MAESTRO-03 trials are discontinued.

Intended Use:
The Dirucotide ELISA is used for estimation of Dirucotide in serum, plasma, or tissue extracts in
pharmacokinetics, peptide delivery study and other purposes.

Principle:
The Dirucotide ELISA is a competitive immunoassay for the determination of Dirucotide. The antiserum is
captured by antibodies coated on a 96-well plate. A constant concentration of Biotin Concentrate and varying
concentrations of unlabeled standard or sample compete for binding specifically to the antiserum. Captured
Bt-tracer is subsequently bound by SA-HRP (streptavidin-conjugated horseradish peroxidase), which
produces a soluble colored product after a substrate is added. The enzyme reaction is stopped by dispensing
an acidic solution (H2SO4) into the wells after 10 min at room temperature turning the solution from blue to
yellow. The optical density (OD) of the solution at 450 nm is inversely proportional to the amount of specific
Dirucotide bound.