https://fdaaa.trialstracker.net/trial/NCT04543994/
https://fdaaa.trialstracker.net/trial/NCT04548583/
https://ichgcp.net/clinical-trials-registry/NCT04548583
@dachopper
Not to mention in October and November 2023, when we will reach the expected completion of two 3 year Phase 1/2 trials for Crohns Colitis and Ulcerative Colitis being undertaken by the Cleveland Clinic. Whilst the primary endpoint of these trials is safety, some early feedback presented at ECCO suggests very favourable data for what are potentially multi billion dollar indications . I would expect a further phase 3 trial or phase 4 to be undertaken ….because Meso will probably require additional clinical data …but assuming sr aGVHD is approved , I am thinking partnering in these indications might be in prospect ..to fund the next step’ The mistake investors often make, is to assume that there will be no news for some length of time in other indications …whereas the ability to partner in advance of a trial starting (or fund with a royalty deal) might have major implications for a Company like Mesoblast ! Remember also, sr AGVHD is believed to share a similar T cell mediated pathophysiology to Crohns…so will probably be able to use the existing T cell potency assay. I am not sure Cleveland Clinic completed full enrolment for this trial , because many of their treatment suites were closed for COVID. I suspect, however, from the poster release by Amy Lightner at ECCO, that the margin of improvement in patient outcomes was substantial enough as to negate the need for full enrolment… but that is just speculation from me . OP
https://www.ecco-ibd.eu/publications/congress-abstracts/item/p428-a-phase-ib-iia-study-of-remestemcel-l-an-allogeneic-bone-marrow-derived-mesenchymal-stem-cell-product-for-the-treatment-of-medically-refractory-crohn-s-colitis-a-preliminary-analysis.html
Please do not rely on the facts ,opinions or links, continued in the above post when making an investment decision.
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