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Adult Stem Cell News and Developments other than Cytori
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TOPIC: Potentially Huge News from Mesoblast

Potentially Huge News from Mesoblast 16 Aug 2015 19:05 #4984

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This could be the BIG news that ignites the entire sector.


“We are particularly pleased with the outcome of the recent meeting between our development and commercialization partner Teva Pharmaceutical Industries Ltd (Teva) and the United States Food and Drug Administration (FDA) regarding our Phase 3 chronic heart failure program. The ongoing Phase 3 trial continues to recruit well and, as a result of the FDA meeting, has the potential for early completion based on overwhelming efficacy.”

The investment community has been waiting for news that shows stem cells have the potential to deliver on the promise after decades of investment. This may be a blockbuster that benefits all players. Interesting timing in that Arnold Caplan mentioned Mesoblast and Athersys in the recent paper I posted and now this news from Australia. If Cytori delivers on Osteoarthritis, the Mesobast news only helps enhances the story. Cytori has a lower COGS than Meso, IMHO.

WST
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Potentially Huge News from Mesoblast 16 Aug 2015 20:38 #4985

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I agree worth following but still a long road for MESO...let alone how far behind Cytori is now in cardiac. :bash:

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Potentially Huge News from Mesoblast 17 Aug 2015 06:54 #4986

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The PDF you attached said this about the result of the FDA discussions:

Key outcomes of the FDA meeting were as follows:
There will be a reduction in the total number of subjects to be recruited for the ongoing Phase 3 trial, using a time to first event analysis of heart failure-related major adverse cardiovascular events (HF-MACE) as the primary endpoint, from approximately 1,730 to 1,165. An interim analysis will be performed in the ongoing Phase 3 trial when 50% of the HF-MACE have occurred, which will include a test for superiority allowing for the possibility of stopping of the trial early based on overwhelming efficacy.
A second, confirmatory study is planned to be conducted in parallel in an identical patient population of approximately 500 subjects using recurrent HF-MACE as the primary endpoint. The use of recurrent HF-MACE as a primary endpoint in the confirmatory study is supported by a new analysis of the completed Phase 2 trial, where patients treated with MPC-150-IM had no HF-MACE over 36 months of follow-up, compared with 11 recurrent HF-MACE in the control group (p<0.001, log rank test). This analysis will be presented in full at an upcoming cardiovascular scientific meeting.
The clinical data from these two studies will be supportive to each other for product approval.



If I look at the clinicaltrials.gov record : TEVA/MSB study on CHF

It seems that the study started in early 2014 and the primary end point : Time to first heart failure (HF)-related major adverse cardiac events (HF-MACE) [ Time Frame: 5 Years ]

Personally even if I wish every player in the regenerative world all the best- this tech does not work in my view and it will show when the time comes as long as the trial remains firmly double blinded.

From the study record it is not clear how treated and control are split up, nor what the dosing is- we have to wait and see, but I do not expect any miracles.

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Potentially Huge News from Mesoblast 17 Aug 2015 10:54 #4987

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Fas,

Personally, I also don't know if Meso will be successful in CHF but I hope they are and I think the news looks encouraging. I don't own any Mesoblast, BTW. A big success in CHF would raise the tide for all players, IMHO. That's how Wall Street works. I know you were a big fan of Arnold Caplan. He went out of his way to mention Mesoblast (and Athersys) in his last publication on MSCs. How do you reconcile Caplan's views with yours on Mesoblast?

BTW, I think many apps will work, including those pursued by Cytori. Its just a question of who can show great data and execute. Execution has been our biggest problem so far.

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Potentially Huge News from Mesoblast 17 Aug 2015 12:01 #4988

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Agree Hedge.. Essentially, Cytori no longer has a cardio program as they are focused on the lest costly, low hanging fruit.

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Potentially Huge News from Mesoblast 17 Aug 2015 12:21 #4989

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How do you reconcile Caplan's views with yours on Mesoblast?


WST-

I think the Caplan theories on pericytes make a lot of sense and that those precursors on vessel linings can be activated into MSCs i.e. become adult stem cells by the established definition.

Explains also beautifully why MSCs are found through-out the body, basically everywhere.

I watched the 7 video´s with Caplan which were made of his presentation in Panama at Neil Riordan´s Regenerative Institute many times, but never was impressed or really convinced about his "connecting" Osiris technology (the Company he founded very very early on- that is a long time ago) to his own theories. The mass culturing do not fit in the theory and have no place in it, as I see it. The same applies to MSB, although when I read the science section of their homepage, I do read "Caplan" again.

We should not forget that Arnold has commercial interests too- from that perspective, mentioning the "leaders" in the space- does not hurt. :whistle:

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Potentially Huge News from Mesoblast 17 Aug 2015 13:20 #4990

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Fas,

I do agree on the need to look out for commercial interests. In the Caplan paper this was the disclosure:

"A.I.C. has uncompensated employment, has compensated royalty from Osiris to Case Western Reserve University, is an uncompensated consultant for Celgene Cellular Therapeutics, and has uncompensated stock options in Cell Bank Therapeutics. R.H. has compensated employment with Cellgene Cellular Therapeutics and compensated stock options in Cellgene Cellular Therapeutics."

No mention of Mesoblast or Athersys. Osiris sold MSC assets to Mesoblast but still operates independently with a major focus on wound healing.

If there is a connection to Mesoblast it was not disclosed and I don't think there is.

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Potentially Huge News from Mesoblast 17 Aug 2015 14:04 #4991

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If there is a connection to Mesoblast it was not disclosed and I don't think there is.


Sure- if there was one, the news would have told us. I know Caplan was a (part-time) CEO of an orthopedic venture a few years back, which folded, which was totally unknown even for insiders.

"With commercial interests" I meant more that when he presents his science to audiences, he would very unlikely refer to some unknown Company he worked for himself, but mention only the "gorillas in the space" which his audience can relate to and most likely know about.

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