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col69

15,664 Posts.

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23/05/17

08:14

Post #: 24848151
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Originally posted by 8thmaker ↑

Yankee - the point is you claimed Vericel had completed "just a Phase 2 trial" (singular) that failed, and implied that MSB should therefore have no problem getting RAT designation for multiple products (incidentally, it's actually called RMAT designation now). The reality is that Vericel has completed three trials with this product, all of which met their primary endpoints. I'm not sure what you think you achieve by misrepresenting this - but in any case, I just wanted to point out the facts in case others are unfamiliar with Vericell. I'm not saying MSB can't get RMAT designation(s), I'm just saying that's not necessarily a slam dunk, as they don't have the same amount of clinical evidence in favour of any of their products at this point in time.

By the way - I have read the Vericel peer reviewed publication in The Lancet. It states:

"To the best of our knowledge, ixCELL-DCM is the largest cell therapy study done in patients with heart failure so far. The transendocardial delivery of ixmyelocel-T in patients with heart failure and reduced ejection fraction due to ischaemic dilated cardiomyopathy resulted in a significant reduction in adjudicated clinical cardiac events compared with placebo leading to improved patient outcomes."

and

"In conclusion, the transendocardial delivery of ixmyelocelT resulted in a significant reduction in clinical cardiac events driven by both cardiac mortality and cardiac admissions to hospital at 12 months compared with placebo. IxmyelocelT could be a cell therapy option for patients with NYHA class III/IV ischaemic congestive heart failure who have exhausted optimised medical therapy. To the best of our knowledge, ixCELLDCM is the largest randomised doubleblind clinical trial to date for cell therapy use in congestive heart failure. The effect of an autologous biological agent on the clinical outcomes of ischaemic dilated cardiomyopathy has great potential for the future of congestive heart failure management."

While you say you understand the significance of secondary endpoints, it doesn't seem like you do. As explained in the Lancet publication, "The improvements in clinical events seem to be more significant than the improvements in left ventricular function and therefore more studies are necessary to determine the mechanism of benefit for this therapy.". In other words - there is still an open question about how the treatment works, but the improvement in clinical outcomes is clear. Clinical outcomes are what matter most - to patients, regulators and payors.

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