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TOPIC: What to look for in ATHENA results

What to look for in ATHENA results 01 Nov 2015 09:22 #5379

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ATHENA I had 28 patients treated and II an additional 3 I believe. As a pilot trial and the first one in the US obviously its designated as a safety clinic, which has the following endpoints...

Treatment emergent SAEs
Arrhythmia assessment via Holter monitoring
MACE defined as cardiac death and hospitalization for heart failure


Hopefully Hedrick will NOT- like he did with ADVANCE- give us another run by the nose, by NOT providing the efficacy data which are all in the feasibility or secondary endpoints-

Feasibility endpoints include:
Change in mVO2 at 6 months
Change in LVESV/LVEDV at 6 months
Change in ejection fraction at 6 months
Change in perfusion defect at 6 months
Resource utilization
Change in heart failure symptoms, angina, and quality of life through 12 months


Obviously- this is all that matters. We know ADRCs are safe, so only feasibility should be of interest.

From that perspective we have LVESV and LVEF from the MSB trial to compare to, which should be interesting. As a reminder those were as follows for their CHF trial :



Especially this functional measurement is interesting since MSB says that all patients with >100 ml of blood at the end of contraction, or systole, and the beginning of filling, or diastole are served the best with cell therapy. Do not forget a typical value is 50 ml -so high values mean the heart is not functioning well due to the contractility issues and afterload.

EF is old and not so relevant any longer- but could be indicative depending on certain detail data....




Curious how ATHENA will compare. :cool:
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Board moderator and Site-owner. I still regret the day I started analysing the prospects of MacroPore (now Cytori) back in 2004- a left-over from the tech-bubble at that time from the century change in my portfolio- and became addicted to Cytori´s fat cell technology. :cry:

What to look for in ATHENA results 01 Nov 2015 09:51 #5380

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That's Fas but I will be very impressed if we get anywhere near that kind of detail from Hedrick. I shouldn't have to be but that darn communication history is fairly consistent :evil:

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What to look for in ATHENA results 02 Nov 2015 08:41 #5385

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that kind of detail from Hedrick


Well Hedge- those slides look somewhat complicated and "busy", but are in actual fact quite simple.

MSB did 3 doses on its 60 odd patients- so you see combined results and the three doses separate (which were all over the place- good and bad) for each feasibility parameter and than for the different points in time measurements- 3,6 and 12 months.

Cytori will have only one dose mixed presumably and that compares really only to the 150 mio dose of MSB, since that is the one they selected for the Phase 3 of TEVA. :whistle:


Is that not interesting???? They selected a dose for which the LVEF DECLINED- ABSOLUTE- AND DRASTICALLY COMPARED TO THE OTHER DOSES AND WHICH WAS EVEN WORSE THAN PLACEBO AT 12 MONTHS!!!!!!!!!!!! :KO:

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What to look for in ATHENA results 02 Nov 2015 09:33 #5386

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We will know in 4 days.

To me, the tea leaves say, don't expect much.

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What to look for in ATHENA results 05 Nov 2015 20:45 #5429

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***To me, the tea leaves say, don't expect much. ***

Those pesky tea leaves, eh Fas ?

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What to look for in ATHENA results 06 Nov 2015 06:48 #5433

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***To me, the tea leaves say, don't expect much. ***


Hedge- I am Ok with the stated reason and the fact that a presentation and peer reviewed paper is on its way.

We all know cardiac has no priority at this point, but that could be re-visited was the statement. I am OK with that too. At least we got a rational explanation, which WAS NOT THE CASE WITH ADVANCE. I hope we are allowed to learn from that too, sometime in the future.

CHF treatment with ADRCs the Okyanos "delivery way" still has a tremendous future I believe- but not anytime soon. So be it. :bye:

Now, let me turn to Athena, which is our cardiovascular trial. In last quarter, Cytori received and reviewed the 12 month data from a truncated Athena I, Athena II trial. As you know we stopped enrollment in the Athena program prior to full enrollment. A total of 31 patients with end-stage ischemic heart failure were enrolled.
We learn the following from the combination of six and 12 month data, that delivery of Cytori Cell Therapy in patients with advanced coronary artery diseases impaired left heart function is feasible in a U.S. critical care setting, which includes that harvest procedures, cell processing, mapping of the left heart to find an optimal location for cell delivery and then multiple injections into heart muscle, all done in the same day.

We made a number of modifications to that trial through protocol amendments, which allowed us to improve the overall efficiency and safety profile of that very long and taxing clinical trial procedure day. That whole process was extremely helpful in showing us and proving to us that autologous therapy, such as this can be used in a critical care patient setting in very sick patients.
It's not surprising, as we look at the data and it's consistent with our previous guidance that definitive conclusions on a limited sample size 31 patients that have associated variability in underlying disease was just not possible, however, trends we're seeing and endpoints related to symptomatic benefit in these patients with end stage disease, although we can't say that those are associated with changes and physiologic variables, such as those measured by ejection fraction.
The six months data alone was submitted, but was not accepted for presentation. And we are currently combining the six and 12 month dataset to present at a scientific meeting and also developing a manuscript concurrently for peer-review journal. So our plan at this point is to put the full dataset out there once we have acceptance to a scientific meeting and also peer-review publication.
So to be clear, we saw some very interesting signals in the data. However, at present, we have no plans to invest in further development of cell therapy technology for cardiovascular disease. But at some point, we may revisit that in the future.

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What to look for in ATHENA results 12 Nov 2015 06:08 #5471

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Fas, it would appear that you are not alone in not being impressed with the Mesoblast data. Lets hope that the ATHENA data, even if only a small sample size provides more info of a positove nature than Mesoblast. I get the feeling that Mesoblast's product apart from being allogeneic is hampered by effectively not containing the multitude of other regenerative cells that comprise the SVF.

seekingalpha.com/article/3665166-mesoblast-an-aussie-biotech-cooking-up-a-turkey-for-american-investors

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What to look for in ATHENA results 12 Nov 2015 09:17 #5472

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Thanks for the link, John.

Very informative and well researched article, which I generally agree with except for the shorting part. :evil:

My best guess on the reason why that is: loss of POTENCY due to the infinite culturing, which does not make sense from a biological perspective- somehow cell copy number 2 cannot be of the same quality of copy cell 200.001 is my hunch. :whistle:

Anyway- also the 150 Mio cells choice is somewhat suspicious, because of the general theory that endogeneous receptor cells are required for a therapeutic impact- there are likely not enough resident cells available and the threshold already coming at 40-50 Mio.

As usual - time will tell :cool:

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What to look for in ATHENA results 12 Nov 2015 09:32 #5473

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rongside

Are you expecting 12 month ATHENA data to show something vs the pathetic 6 month "hints" ?

"Hints" that they didn't even want to release mind you. :bang:

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What to look for in ATHENA results 12 Nov 2015 15:01 #5479

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Fas, Have you ever seen these Phase II results from Celyad for CHF?

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What to look for in ATHENA results 13 Nov 2015 06:16 #5482

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Celyad? The link brings to this

Cardiopoietic Stem Cell Therapy in Heart Failure
Journal of the American College of Cardiology, Volume 61, Issue 23, Pages 2329-2338
Jozef Bartunek, Atta Behfar, Dariouch Dolatabadi, Marc Vanderheyden, Miodrag Ostojic, Jo Dens, Badih El Nakadi, Marko Banovic, Branko Beleslin, Mathias Vrolix


which is the C-CURE trial of cardio³ - we discussed that in detail back in 2013 with Christian Homsy-their CEO- and others at LinkedIn...yes.

I know that one very well :yep: A lot of commotion on a few minor issues technically :whistle:


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What to look for in ATHENA results 13 Nov 2015 07:58 #5483

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Fas, I understand your point about the likelihood of the infinite culturing having a negative effect on the potency of the stem cells utilized by Mesoblast. It seems very likely to be a key failure in the approach used..

Hedge, I am not privy to the data of the ATHENA trial and therefore do not know what the data shows. I simply feel that the data could well provide positive material insights, both at six and twelve months. Lets not forget that the previous trials were impressive (but small).
The fact is that it is a difficult and expensive trial to undertake at the best of times and we are not in a position to do so. The existing data does not come from a large enough sample to justify strong positive statements. Given that we are not in a strong negotiatiing position and we have some existing trials (OA & scleroderma) that can enhance our negotiating position in the not too distant future it is probably prudent to not let the competition know the data. Why give them a heads up if we are not ready to take advantage of the data. Also there is no reason management cannot show the data to potential partners privately, subject to non-disclosure.

This is an indication that is fraught with complications. There are a lot of trials going on in the space which can provide CYTX with data concerning delivery techniques etc. going forward. No need to be first mover in CHF. We do however need to get it right if we go the partnership route.

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What to look for in ATHENA results 13 Nov 2015 09:32 #5485

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I see :yep:

Cardio3 changed their name into Celyad apparently . I did not know that.

By coincidence, Edison mailed me a short updated analysis of Celyad today,

I might as well pass it on.


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What to look for in ATHENA results 13 Nov 2015 11:24 #5487

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****Why give them a heads up if we are not ready to take advantage of the data.***

I understand what you are saying but that is NOT what Hedrick indicated ...that he was releasing the data next year (6 and 12 month) and that will be far ahead of when we would be able to pursue a new trial.

Data aside, every attempt at enrollment of a Cytori cardiac trial has been pathetically and even unbelievably slow that there seems to be more than meets the eye on acceptance. Others seem to find the patients.

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