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  • tepper_mark tepper_mark Apr 23, 2005 9:28 PM Flag

    Limited Return Of T Next Week

    This will be announced next week on the conference call, inside source has told me. Also Elan continues to hire new employees and no lay offs have been announced. This does not imply a company that is in trouble....

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    • If no additional cases of PML are found by the time of the CC, I'd expect KM to be able to announce that trials will resume as of a particular date. Given the PML cases, it's important for T use in studies of existing patients to continue to demonstrate mono- safety. Patients who have experienced the benefits of T will be willing to continue.

    • Your inside of your head tell you that T will be back next week? It is possible. No telling why it can not. There are many theories and facts about PML brought out to the board and potential cerebral immunosupressive effect of Tysabri has been discussed. There is nothing concrete to relate T directly to 3 cases of PML. By now , all 3000 cases of post market T recipient may have been investigated and found no suspects. They may want lab test before reintroduction to make it sure that T has no adverse effect on JCV activation but this undertaking will be no simple matter and will involve complex multistage immunocytological testings while the ultimate conclusion of positive or negative will still have no direct bearing in real clinical setting. FDA will conclude re-introduction of T is justifiable and the close postmarket surveilance is the only reasonable solution. It seems reasonable to assume that any combination with other MS drugs currently in use is not recommendable since there seems no significant additive benifit is foreseen. I am not saying T should be given clean bill. It is not hard to envision there is more than blocking migration of lymphocytes when VLA-4 is blocked by Tysabri. It is safe to say the long term effect remains to be seen. Tysabri is likely the 1st choice of all newly diagnosed MS and continue unless there is progressive neurological signs on each subsequent relapse. Use solumedrol during acute phase of relapse while withholding T. Conversion from other drug treatment such as Avanex requires tests profiling immunosupression status including CSF for JCV genome. JIMO.