Interview with Silviu Itesu – CEO of Mesoblast

by Alexey Bersenev on July 17, 2012 · 0 comments

in cell product, interviews

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I’d like to bring your attention to this interview, because it gives a big picture of idustry-sponsored adult stem cell clinical trials.

To watch interview, follow this link

A few interesting things which we can learn from the interview:

  • Mesoblast is planning to get (FDA) approval for heart failure Phase 3 trial, which will include 1500(!) patients. If they succeed, it will be the largest clinical trials in history of cell therapy. Well, from n=60 in Phase 2 to n=1500 in Phase 3. Isn’t it huge leap? He mentioned that Phase 3 could be finished at n=500 if interim results will be as good as in Phase 2. I wonder how number of subjects in trial is set? Why there is a big difference between number of patients in different Phase 3 trials?
  • Alliance with Big Pharma to commercialize adult stem cell products. This Phase 3 trial will be sponsored by Teva. Teva will have rights to distribute a product after trial and commercialize. So, the cost of Phase 3 is so high, that stem cell companies have to find a strategic partners. Is it a commonly accepted scheme now?
  • Up to 15 000 therapeutic doses from one young healthy donor. As I mentioned before, I can’t get how it is possible. Am I miscalculating?
  • He indicates that cells do not integrate in myocardium and persist for about 2 months. Obviously, the mechanism is paracrine/ trophic and cells act as long-term drugs. He believes that one of the mechanisms is mitochondria transfer from cells to host myocardium.
  • Finally, I’ll be very curious to watch how Mesoblast will compete with Osiris on the market.

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