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.
(20min delay)