Yes I understood that those were possible future indications for...

  1. 274 Posts.
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    Yes I understood that those were possible future indications for the use of Cx601, and that could lead to an expansion of income to TiGenix/Takeda and the royalty stream to Mesoblast.

    I used a document from the European Medicines Agency (EMA) help me understand how Alofisel was going to be administered, p. 2, sec. 4 Clinical Particulars, and especially the section Method of Adminstration on pages 3 and 4. Extremely graphic too but in the textual sense
    http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/004258/WC500246474.pdf

    Finally you wrote;
    "As you can see, these are two separate disease targets with two separate MSC products trying to address them."

    That is what I was trying to convey with the following in my first post above;

    "Why would MSB bother to continue with a Crohn’s Disease treatment when Takeda have one about to be released across the EU? Because the targets of the treatment are different. I have bolded some bits for clarification."

    For added clarity I could have included the primary and secondary outcomes of the MSB Crohn's Disease Trial, so I will here;

    "Current Primary outcome measures:
    Disease remission (CDAI at or below 150) [ Time Frame: 28 days ]

    Current Secondary outcome measures:
    • Disease improvement (Reduction by at least 100 points in CDAI) [ Time Frame: 28 days ]
    • Improvement in quality of life (IBDQ) [ Time Frame: 28 days ]
    • Reduction in number of draining fistulas [ Time Frame: 28 days ]"
    From;
    https://www.clinicaltrials.gov/ct2/show/record/NCT00482092

    So the primary aim is the Induction of Remission as defined, the secondary less desirable but definitely OK effects include but are not limited to, a reduction in the number of draining fistulas. The specific type of fistula is not mentioned in the trial description however the eligibility criteria includes;

    "endoscopically or radiographically confirmed Crohn's disease of ileus or colon or both"

    After a little searching I think that means enterocutaneous fistulas are covered, however the other types of gastrointestinal fistula are not listed as a cause for exclusion. Whether or not a person would have multiple types present simultaneously I have no idea.

    As you might infer from the above, I have no medical training at all. I'm just a share holder who likes to do a bit of that DYOR thing.
    Last edited by Treed: 08/04/18
 
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