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TOPIC: To Athena or not to Athena

To Athena or not to Athena 05 Nov 2014 09:42 #2594

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To Athena or not to Athena- that is the question.

Which will keep us busy over the next few days I presume. If you believe Kolbert and the grapevine, we will be told tomorrow Nov 6 that Athena will be unblinded.

I agree with others- that this is sad and a setback for development of the business in the US. But at the same time good for Okyanos and other clinics who will be offering the therapies going forward.

My thesis is- that is the right decision in view of available data so far and time passed. In my opinion PRECISE in hindsight was bad luck and a bad job by the PI´s. APOLLO too small to count, so we need the 25+31 data from ADVANCE and ATHENA to make an impact on a potential partner for cardiac to have the app developed with help.

Cytori is too dumb and incompetent to do it alone- and simply lacks the funds. :evil:

To prove my thesis - I will go over PRECISE again and look at the latest 5 year studies of the competition.

But beware - I am biased- I am not even going to look at allo mass-cultured stuff. Long term, I do not see a future there period. :KO:

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To Athena or not to Athena 06 Nov 2014 11:27 #2602

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In my opinion PRECISE in hindsight was bad luck and a bad job by the PI´s.


Mark Saad announced early 2014 that the 3 years data of PRECISE would/could be a PPS moving event. Probably a lot of bonus money on that which is normally ONLY done by the PI´s. Anyway- those guys did a real lousy job. The paper published on PRECISE is like a cold shower instead of stimulating.

If this is all the data they had- it is surely A BIG SURPRISE that Daiichi Sankyo almost made a deal with Cytori for a whole lot of money!!! Since they almost did, Cytori must have more data on cardiac. Even late 2012!!! There is NO doubt in my mind after reading this. The same argument applies to the investors in Okyanos.

Anyway- the paper acknowledges that ONLY safety data were followed up to 36 months, but fails to report the most relevant safety criteria- mortality at the 36 months point- only the known 18 month data are presented. :bang:

No efficacy data at all for 36 months.!!!!!!

Without wanting to go in great detail on something that had my undivided attention for 7 years (i.e. cardiac therapy and in particular PRECISE)- only the KEY conclusions:

See next post- here is the paper for a starter.... :grin:


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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:

To Athena or not to Athena 06 Nov 2014 13:02 #2603

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a bad job by the PI´s.


I assume here that the reader of this board has some basic knowledge of PRECISE either from the past or from reading the paper presented in the previous post. :whistle:

Key thing of the study: the initial "n" of 27- that is 21 treated and 6 placebo managed to produce a statistically significant difference between treated and placebo in respect of MVO²- the measurement of oxygen consumption during exercise by cardiac patients ( which is also used to determine who goes on the heart transplant list). The same applied to METS but that is kind of the same thing.

That was very very impressive but a RESULT!!! There were NO physiological measurements i.e. parameters of functional cardiac performance measurements that supported that RESULT!!

Except:



It was very astonishing to find out that MRI was ONLY measured at the 6 months interval and not at 12 and 18!!!!

Why????? I do not know- does not makes sense if you consider the following from my predecessor page...

The PRECISE endpoints are more of a soft nature, but functional measurements like LVEF or infarcted cardiac mass are highly interesting too, of course. Because of that- we start with a review of methods in measuring functional parameters EF etc of the heart. Basically three (main) imaging methods are used- SPECT (Single Proton Emissions Tomography) is your well-known radiology tech used in most coronary angiography or catheder procedures with or without contrast media- picture top left.


If you ever have been on the table of a cathlab like this, I am sure you recall pictures of the coronary flow of your heart like the one you see on the right. The tech is highly suitable to spot occlusions and flow issues in as well as 2-D as 3-D, so you can properly position a stent to remove the problem.
But as I learned from a discussion with Alex Milstein of Cytori a while back, not particularly suited for measurements of LVEF etc. For that, the golden standard is MRI (magnetic resonance imaging, also called NMR-Nuclear Magnetic Resonance), which is also less invasive, because of the lesser(radiation!) cancer issues involved (picture left), closely followed by the method used in every single cardiology practice- the echocardiogram, based on the doppler-effect of soundwaves, which is the bread and butter nowadays for every heart specialist and also a very reliable measurement technique.



[/b]


MRI seems relatively harmless and has NOT been measured at 12 and 18 months. Astonishing really... :cry:
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To Athena or not to Athena 06 Nov 2014 14:13 #2604

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PRECISE in hindsight was bad luck


That becomes clear if you read the first line of the image....



The difference in AGE between placebo and treated group was 10 YEARS.

Thats bad luck since considering that the average "developed world" person reaches the age of 80, being 15 or 25 years away from your "destiny" makes quite some difference, especially for a cardiac patient who fits the "profile- i.e. inclusion parameters" for the PRECISE trial.
Meaning simply- they do not fit the bill of making that average of 80 years so to speak.

Anyway- that really distorts the comparison heavily and from that perspective you should look at some of these numbers comparing treatment versus placebo i.e. knowing that the treated patients were really very sick folks...and therefore started with a lower baseline...




Knowing all that those graphs make sense- however are difficult to explain.

New data is wanted and needed - Okyanos will help if they will produce "peer reviewed studies" as is planned for Lesley Miller et al. This is not so much Cytori´s competence, so probably the decision to unblind ATHENA is the best thing to do right now.... :KO:
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To Athena or not to Athena 06 Nov 2014 14:59 #2605

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So Fas, are you saying to sell CYTX or there is still some hope ?

In my opinion, many of the same bozos that couldnt fix this poorly designed trial before it even started are still running this company.
Do you still feel some white knight is going to come in, pick up all the pieces and run a REAL trial and prove Cytori's science for them ?

Small trials prove little.

Bigger question is why could they never attract patients to ATHENA in a timely fashion ?

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To Athena or not to Athena 06 Nov 2014 15:23 #2606

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So Fas, are you saying to sell CYTX or there is still some hope ?


I never was a trader and tried to avoid making any statements like that in the past. When I did, I stole or copied recommendations from third parties- forgot will know who I mean. I am just sticking to the tech and hope for the best. :KO:

Do you still feel some white knight is going to come in, pick up all the pieces and run a REAL trial and prove Cytori's science for them ?


The real white knights at present are the Feshbach´s and Lim´s of this world. So- to answer your question- NO, I do not think there will be somebody at PRESENT to pick up the pieces and do a real trial. I think the ATHENA protocol is against the Helsinki convention and against human rights and dignity. But thats more a FDA than a Cytori issue and I feel bad for Mac who was in this trial and feels he was placebo.

So- fuck them FDA and prove the tech anyway you can.

Small trials prove little.


Statistical power is everything- but statistical significance with 40-50 patients in a well designed trial, convinces the ones who know.

The issue that we have at present is that the "white knights" are dealing with a Company which is clearly unsuccessful- that HAS to change for THEM (the white knights) to be really successful.

The magic to do this also eludes me at present.... :bash:

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To Athena or not to Athena 07 Nov 2014 10:20 #2620

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So- the confirmation of unblinding ATHENA came yesterday..

Cardiovascular Disease
The US phase II ATHENA trial of Cytori Cell Therapy on patients with heart failure has been on clinical hold since May 2014 over a concern following reports of cerebrovascular ischemia in 3 patients. During this time, a thorough investigation, both clinical and preclinical, was completed. The full report was submitted to the FDA on September 19, 2014. During this period, the Company found no data to suggest that Cytori technology led to these adverse events. In fact, the data generated strongly supported previous data from the Company and its users regarding the safety of the Celution® System and its cellular output. The FDA response to the Company’s submission was received on October 22, 2014 and noted they had no subject protection concerns and Cytori was free to proceed with the trials with the protocol amendments proposed by Cytori.
Currently the ATHENA phase II trials have enrolled a total of 31 patients (28 of 45 in ATHENA and 3 of 45 in ATHENA II). Based on the enrollment thus far, minimal loss of statistical power and the fact that during the delay the Company has made substantial progress on it next generation Celution® system, the Company has determined the most prudent course of action is to stop enrollment at 31 patients and analyze unblinded six month data. The 31st patient will reach the planned 6 month time-point this month. An analysis of the complete and verified 6 month data should be available early in 2015 for review and planning next steps.


Besides mentioning the fact of progress in the development of the CRX machine, in the call Hedrick also spoke of "significant advances" in respect of the delivery method of bringing cells to the heart.

That sounds good, since first the NOGA equipment is expensive and the electromagnetic burden for the patient not really a healthy thing as we have seen.
I will touch base with Matt in see what we can learn here. Okyanos, I believe do not use NOGA so they will probably have the latest, greatest and believe me - DELIVERY is important!!! :winky:

As a guidance...



The bottom picture depicts how the NOGA system works- separate injections at weak points of the myocardium. I presume the "new" stuff will be some regional- localized tech hybrid. :yep:
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To Athena or not to Athena 08 Mar 2015 15:57 #3687

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@ all

what are the expectations about the Athena (not Apollo) data? In line with former trails?

What i think is that the market can not identify good results from in line results. They need a valuation perhaps from a partnership.

Regards holdi

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To Athena or not to Athena 08 Mar 2015 23:03 #3689

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Old Young Fox wrote: @ all

what are the expectations about the Apollo data? In line with former trails?

What i think is that the market can not identify good results from in line results. They need a valuation perhaps from a partnership.

Regards holdi


You mean ATHENA?

Regarding the market distinguishing good from bad results (with the small cap status of Cytori), I think that, given the new interest in the stock (even though, realistically that's maybe 2% of the float), it's up to investors who can give their take on the results to try to decipher them, have a discussion about them, and make that information known to all.

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To Athena or not to Athena 09 Mar 2015 04:19 #3690

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Yes i mean Athena

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To Athena or not to Athena 09 Mar 2015 12:35 #3696

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Holdi-

I remember in May 2010 the whole Cytori clan including myself was in Madrid where Duckers and Perin presented PRECISE and APOLLO data for the first time.

CC had even made video´s explaining the results - Perin and Duckers too and on top of that there were interviews with patients. All very neatly done and with information of substance.

The market reacted with a yawn- because nobody apparently knew it was coming and nobody cared. :evil: :bash:

I think the market is a lot more sensitive now- BIG MONEY seems to be aware of Cytori and is waiting for that type of news I would think.(=hope)

I also think Hedrick will let out other news on cardiac studies when it suits him- (probably when a partner is near and angled). There is no doubt in my mind that studies are completed in the cardiac field that we do not know about. :bang: :bang:

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To Athena or not to Athena 09 Mar 2015 13:11 #3697

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***The market reacted with a yawn- because nobody apparently knew it was coming and nobody cared.***

They were just too small imho for big money to care and we had the same problem back then as taking forever to enroll a handful of patients.
Imagine if they had to fully enroll....we be getting data today...LOL

ATHENA will also be a small sampling however being run here may attract some more attention. Also its controlled with two dosing sizes when including ATHENA 2's two treated patients.

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To Athena or not to Athena 09 Mar 2015 15:26 #3705

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yes fas i read it here many times that cytori has more informations/results out of not shared trails. My interest is only how good or bad the athena results which will be distibuted are.

That KT Lim or a potential new partner saw more data from cytori is clear.

May the fat be with us.

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