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TOPIC: Combined Athena Data Published

Combined Athena Data Published 28 Jun 2016 06:08 #7335

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SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) today announced that the results from the ATHENA Trials have been published and are now available online in Catheterization and Cardiovascular Interventions, a leading international journal covering the broad field of cardiovascular diseases and the official journal of The Society for Cardiovascular Angiography and Interventions that has over 4,300 interventional and invasive cardiologist members in over 70 countries.

The ATHENA trials are two prospective, randomized (2:1, active:placebo), double-blind, controlled, parallel group trials (ATHENA and ATHENA II) each assessing Cytori® Cell Therapy™ [ATHENA: 40 million cells, 28 patients; ATHENA II: 80 million cells, 3 patients]. The objective of the ATHENA program was assessment of safety and feasibility of Cytori Cell Therapy using the Celution® System for automated on-site manufacturing of the cellular therapeutic and intramyocardial delivery for treatment of chronic ischemic heart disease with left heart failure.
On the treatment day, patients underwent fat harvest via small volume lipoharvest followed by cell processing, electromechanical mapping of the left ventricle with subsequent injection of cells (or placebo) into viable myocardium intramyocardial.

Thirty-one patients (17 Cytori Cell Therapy, 14 placebo) were randomized prior to termination of enrollment, with 28 patients having 6 month or longer follow-up data. Trial enrollment was terminated prior to the planned target (45 patients per trial) due to the prolonged period of enrollment and safety reviews. ATHENA and ATHENA II trial data were combined for analyses.

The key results were as follows:
Improvements in the Minnesota Living with Heart Failure Questionnaire (MLHFQ) total score (a validated questionnaire for disease specific health related quality of life) were observed in the Cytori Cell Therapy group relative to the placebo group. The mean (95% CI) between group differences (Cytori Cell Therapy minus placebo) for the change from baseline were as follows:

3 months = -4.7 (-20.3, 10.9) (p=0.54)
6 months = -9.4 (-22.5, 3.8) (p=0.154)
12 months = -16.3 (-31.7, -1.0) (p=0.038).

The SF-36 (a validated questionnaire for generic health related quality of life) results showed trends toward improvement in the Cytori Cell Therapy group relative to the placebo group, with several domains associated with nominal p-values less than 0.05.
At 12 months, New York Heart Association class improved in 57% of ADRC-treated patients compared to 15% of placebo patients. The corresponding values for the Canadian Cardiovascular Society class were 67% and 27%.
Echocardiogram and treadmill testing was performed at baseline and 6 months post-treatment. The mean change from baseline to 6 months in maximum oxygen consumption was 45.4±222 mL/min (ADRC, n=15) vs. -9.5±137 mL/min (placebo, n =10) [mean (95% CI) between group difference = 54.9 (-109, 219), p=0.495]. Left ventricular ejection fraction, left ventricular end-systolic volume and left ventricular end-systolic volume showed no relevant differences between groups.

Heart failure hospitalizations were reported in 3/17 (17.6%) and 5/14 (35.7%) of cell treated and placebo treated groups respectively. Central adjudication of these events showed the respective numbers to be 2/17 (11.7%) and 3/14 (21.4%).
Regarding safety, 18 of 31 patients (58.1%) were reported to have at least one serious adverse event during the trial (Cytori Cell Therapy 9/17 (52.9%), placebo 9/14 (64.3%)). Major Adverse Cardiovascular Events (MACE) occurred in 6/17 (35.3%) of ADRC patients and 3/14 (21.4%) of placebo patients. Two fatal events were reported during the trial with both occurring in the Cytori Cell Therapy group (myocardial ischemia – day 2 post-procedure, decompensation of heart failure – day 291 post-procedure).
The authors stated “… it appears feasible to harvest, process on-site, and deliver autologous ADRCs on the same day to patients with severe ischemic cardiomyopathy. ADRC delivery was associated with signals of benefit on both patient reported outcomes and ischemic burden.”

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Combined Athena Data Published 28 Jun 2016 06:12 #7336

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Are these good or bad results?

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Combined Athena Data Published 28 Jun 2016 07:00 #7337

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With Cytori, an investor always has to parse the words to determine if there is meaningful results. But, here is what I see.

1) Even though this was terminated early, it was double blinded placebo controlled with approved FDA predetermined endpoints. Very legitimate test.
2) In the Minnesota Living with Heart Failure questionnaire. Cytori failed endpoints at 3 months and 6 months but passed at 1 year. This is another example of the continued improving benefit of cell therapy. It is not like drugs. It is showing examples of rejuvenation.
3) There were some sub-classes of groups that showed some promise with some measurements but no further analysis was provided by Cytori. Unless there is some logical connection to the sub-groups or a consistent pattern such as administration time from the initial heart attack, I am highly suspect of the benefits.
4) The objective measurements of echo-cardiogram stress testing showed no material health improvement between Cytori cells and placebo.
5) Adverse re-hospitalizations showed positive results in favor of Cytori but no P values were reported so I assume that there is not real difference.
6) No difference is post procedure adverse health effect between Cytori cells and placebo.
7) There were safety concerns with two patient deaths from the Cytori cell group that caused a stoppage of the study for a safety review. This might have been random or related to the delivery procedure. I highly doubt it was related to the cells themselves.

Generally unimpressive results.
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Combined Athena Data Published 28 Jun 2016 12:36 #7341

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Maybe somebody is so kind to spend 38$ for the paper and send it to me? This email address is being protected from spambots. You need JavaScript enabled to view it. So- I can make some sense of this announcement and report back to you.

There are some obvious mistakes in the announcement and the numbers in respect of the major "findings" from PRECISE- that METS and MVO2 were statistically significant with the small numbers- n=27 and MVO2 as we know- is the major parameter which determines whether or not you come on the Heart Transplant list. PRECISE was able to stop the spiral leading to that list and initial announcement on ATHENA was, that the PRECISE data were confirmed in the trial.


In PRECISE blood flow as measured by SPECT was also vastly improved, which in this announcement was ignored although important.

As we know- good cardiac function and performance reflects the interdependence between myocardial mechanical function, myocardial (not maximum) oxygen consumption (MVO2), and blood flow. Please send me that thing and ignore this announcement. ADRCs work- also in CHF.
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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:

Combined Athena Data Published 28 Jun 2016 13:53 #7343

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Plenty of small group data....showing "hints" in some areas.
Will a partner pay ? Surely they have known this data and no one has stepped forward to date.
Let alone the delivery procedure needs improving, imho.

:yawn:

Wake me when the is real news for this application.

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Combined Athena Data Published 29 Jun 2016 06:17 #7344

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myownhedgefund wrote: Plenty of small group data....showing "hints" in some areas.
Will a partner pay ? Surely they have known this data and no one has stepped forward to date.
Let alone the delivery procedure needs improving, imho.

:yawn:

Wake me when the is real news for this application.


I am used to make up my own mind and do not require the statements of "experts"

And I will wake you up when money news has arrived on cardiac- should not take forever.. :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:

Combined Athena Data Published 29 Jun 2016 11:55 #7346

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***I am used to make up my own mind and do not require the statements of "experts"***
Agree, it just what data is really the correct data and how will it apply to Cytori.


***And I will wake you up when money news has arrived on cardiac- should not take forever***
Thank you, Herr Fas

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Combined Athena Data Published 29 Jun 2016 13:16 #7347

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Fas,

Since you are very well versed in cardio data do you have any thoughts on this small Athersys Phase I AMI tria l? Thanks.

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Combined Athena Data Published 29 Jun 2016 13:35 #7348

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Wall Street Titan wrote: Fas,

Since you are very well versed in cardio data do you have any thoughts on this small Athersys Phase I AMI tria l? Thanks.


WST-
Before hitting the button for the link, which surely will lead to the paper, let me confess from my memory on the paper, that I believed the results were outstanding and I never understood why the small partner they had at the time- did not want to pursue the opportunity and after they returned their rights, why no new significant partner was found beyond the grant received to start the phase IIb, which I believe is in progress ( I do not follow ATHX closely)
Anyway- after analysing that thing , I had some questions for Lehmann, which he promptly answered. So- just positives. Unfortunately I cannot find any notes- since surely I did not make any- so will look again when I have time, which might take a while. Promise.

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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:

Combined Athena Data Published 29 Jun 2016 15:31 #7351

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Fas,

Angiotech, the partner at the time, was a small company with limited resources. We have seen over the years that potential partners mostly want to see Phase II data before they commit big bucks. Atherys now owns all the rights to cardio and good results in the Phase II, that was at least partially financed by a grant , would likely lead to financing from a partner. Given all the stem cell cardio failures I think that most are not putting much value on ATHX cardio as the big focus is on stroke. But I've corresponded with a scientist at Athersys and he believes that MAPCS have capabilities that MSCs don't and they have studies (not all published) to back up their theory. I'm counting on stroke success, AMI would be a bonus. Looking forward to your thoughts.

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Combined Athena Data Published 01 Jul 2016 09:48 #7360

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FAS,

Based on MESO's PR today, I think they will have financial problems to complete the ongoing phase 3 cardio multi center trials and wait for regulatory approval, even though they have $ 80 million in the bank. They will need to spend at least $ 100 million from here. There is no quarantee that the final study results would meet regulatory approval in the US. I worked with Teva for years, they have some very smart people making good decisions. To leave MESO is a very big decision and they must have intelligence and thorough evaluation to come to this conclusion.

From hind sight, CYTX's departure from the cardio indications and now focusing in niche indications, with renewed commercial activities in Japan and also EU is smart.

The question is: what should be done with the Wales site in view of Brexit ?

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Combined Athena Data Published 01 Jul 2016 11:53 #7361

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franshei wrote:
The question is: what should be done with the Wales site in view of Brexit ?


On MESO- I agree. Without saying it explicitly they conceded that enrollment is stopped and the partial unblinding to evaluate the data in 2017 will lead to some serious decision making to continue or not. Personally I do not think they will find a partner to complete the trial and cannot afford it themselves as you already concluded. The "equity deal" they made is not an investor but a simple "Cowens/Seaside" type share selling arrangement. Something avoidable when possible for present shareholders, something Hedrick did not manage to do... :cry:

This development suits me fine- makes Emerson Perin available to do what he wants and hopefully Cytori/Celactive can come to terms to the benefit of cardiac patients.

Your note on Deeside is very smart and excellent question. With the primary purpose---- Lorem Vascular probably disappearing --- there simply does not seem to be any use to the facility at this point. :whistle:

Below you will find the MESO note to investors

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File Name: MESO-UpdateonHeartFailureTrialandFundingofOperations.pdf
File Size: 117 KB
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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:

Combined Athena Data Published 01 Jul 2016 12:05 #7362

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On Brexit and EMA...

The German newspapers already report of political "positioning" for where the EMA HQ - presently in the UK employing about 900 highly qualified professionals- should move to. Bonn in Germany is (of course) a front runner, but Milano Italy has been mentioned and Denmark + Sweden are making their case too.

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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:

Combined Athena Data Published 01 Jul 2016 12:23 #7363

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I don't want to start a political discussion but wasn't Denmark one of the first to say they wanted their own vote on coming out of the EU post Brexit result, and Italy is a giant mess and just the other day secured a multi-billion EU bailout package ( 160 billion ? ) for their banks should bank runs occur.

Germany would be the best and safest choice imho (for now)

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Combined Athena Data Published 01 Jul 2016 14:25 #7364

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I also think Lorem Vascular will either disappear or return the rights. I think Harris will eventually make good use of the opportunity to expand CYTX's marketing territories into China and Singapore, in line of what is being executing in Japan. The original US 510K strategy can now have its days in the Far East, with the new Japanese regenerative medicine regs.

Stem cells or simply cell therapy (except in certain niche indications, such as scleroderma for CYTX) may remain small in the US, as this kind of therapy may work wonders but often "slowly" over time. The US general public is often too impatient for this kind of medicine. Most patients and big pharmas (in particular, with senior management turnover every five years) want to see therapeutic benefits in hours and days, not weeks or months. In general, traditional Asian herbal medicines have hard time to find a place here, while herbal medicines are very much alive in China, Japan, Korea, etc.

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Combined Athena Data Published 04 Jul 2016 10:11 #7376

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franshei wrote: Stem cells or simply cell therapy (except in certain niche indications, such as scleroderma for CYTX) may remain small in the US, as this kind of therapy may work wonders but often "slowly" over time. The US general public is often too impatient for this kind of medicine. Most patients and big pharmas (in particular, with senior management turnover every five years) want to see therapeutic benefits in hours and days, not weeks or months. In general, traditional Asian herbal medicines have hard time to find a place here, while herbal medicines are very much alive in China, Japan, Korea, etc.


Interesting viewpoint.

As a caucasian, who has experience with all kind of possible therapies, I adopted a strategy dealing with "conventional doctors" of being very submissive in regard to their horrible healing methods. As an example- 2 weeks ago my back muscles were really painful since tight and hardened from my power exercises (weight lifting and stuff) and that again caused lower back pain, since my lower spine disks are (also) pretty worn out by a life of sitting behind a desk staring at computers.
So - I ordered privately curcumin (which Centeno also recommends highly for most related Osteo pains) and put the prescribed NSAID in the "permanent waste bucket" and made sure I got my prescription for 10 acupuncture sessions, where due to my friendly nature and good relationship with the doctor, I have a say in which meridians are "worked upon"
After 3 days curcumin my lower back pain is gone. My wife is still working on the muscle pain though- since quite persistent :evil:

I think generally people are getting smarter and the opposition to multi-side effects drug shit is growing. :whistle:

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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:

Combined Athena Data Published 14 Jul 2016 10:26 #7411

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Fas,

Starting on Page 21 of this slideshow you will find more analysis on the Phase I AMI from Atherys compared to other cell based studies. I think you will find this of great interest.
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