Amarin Corp Plc (AMRN)

[jessellivermore]

Very interesting.,,,,

CIRT (Cardiovascular Imflammation Research Study)

This is a collaboration between Paul Ridker (Brigham and Womens Hospital...Harvard Med..Boston) and the NIH...

Ridker was the principal investigator in the JUPITER trial and holds a substantial fraction of the patent for hs-CRP blood test for cardiac inflammation...

CIRT was started enrollment in April 2013 with a plan of enrolling 7000 patients with T2DM and MIs or combos to get 530 primary events.
To treat with RA (low doses) of Methotrexate (MTX) Trial design was 90% power at 25% RRR...With some of the usual SEs..

The trial was halted by the NIH (one of the two sponsors) at the recommendation of the DMC...There were only 4786 patients in the trial. There were no serious safety concerns...and enough data was gathered to"answer the question"...but we don't know what that answer is.

MTX was used to treat cancer initially in very high doses and had very serious (lethal) side effects...This trial employed RA doses which employed much lower doses...There are still a high percentage of "unpleasant" side effects involving the GI tract as well as mood disorders...Some of these can be moderated by folic acid which is depleted by MTX..Patients in this study were also on folic acid.

The study was originally planned to end in Dec 2018...Difficult to understand what went on in this study..The fact there is such a low number of patients in the trial is cause for concern...

":>) JL