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TOPIC: ATHENA Results Released Today- May 5th

ATHENA Results Released Today- May 5th 05 May 2016 04:45 #6906

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11:00 AM
Final Results for THE ATHENA TRIALS: Autologous Adipose Derived Regenerative Cells (ADRCs) for Refractory Chronic Myocardial Ischemia with Left Ventricular (LV) Dysfunction
— Timothy D. Henry, MD, MSCAI



Since cardiac presently is non-core, there would be hardly any incentive, to wait until AFTER the presentation- right? :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:

ATHENA Results Released Today- May 5th 05 May 2016 07:57 #6908

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I truly hope this move will not prove to be another Hedrick blunder.

Who knows what The Stret will consider as positive results.

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ATHENA Results Released Today- May 5th 05 May 2016 22:08 #6918

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Processed fat cells show potential as treatment for refractory ischemia patients
SOCIETY FOR CARDIOVASCULAR ANGIOGRAPHY AND INTERVENTIONS

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Orlando, Fla. - Patients treated with processed autologous adipose-derived regenerative cells (ADRCs) injected into the heart muscle demonstrated symptomatic improvement and a trend towards lower rates of heart failure hospitalizations and angina, despite no improvement in left ventricle ejection fraction (LVEF) or ventricular volumes. The ATHENA trial results were presented today as a late-breaking clinical trial at the Society for Cardiovascular Angiography and Interventions (SCAI) 2016 Scientific Sessions in Orlando, Fla.

ADRCs are a combination of cell types, such as adult stem cells, vascular endothelial cells, and vascular smooth muscle cells. Preclinical data indicates that these cells promote blood vessel growth, modulate inflammation and reduce cell death. These cells can be used in a variety of tissue types, including bone, cartilage, fat, skeletal muscle, smooth muscle and cardiac muscle.

"ADRCs consist of multiple cell types with multiple potential benefits," said Timothy D. Henry, MD, MSCAI, director, division of cardiology at the Cedars-Sinai Heart Institute and the study's lead investigator. "Based on the results seen with ADRCs in the PRECISE trial, we designed ATHENA to look at these cells as a possible treatment option for people with refractory chronic myocardial ischemia."

The phase 2 program was comprised of two prospective, randomized double-blind, placebo-controlled, parallel group trials (ATHENA and ATHENA II). The patients (average age 65 years) in each group (17 ADRCs, 14 placebo) were on the maximally tolerated medical management with an EF score of 20-45 percent. EF, the amount of blood pumped out of the ventricles with each contraction, can be an early indicator of heart failure if the score is 35 percent or below. The baseline average EF score for both groups was 31.6 percent. The patients were also CCS angina class II-IV and/or NYHA class II-III, had ongoing ischemia and multi-vessel cardiovascular disease, but were not candidates for revascularization.

Using standard liposuction, a small volume of the patient's fat tissue (<450 ml) was extracted and then the cells were separated from the tissue and concentrated (Celution®System, Cytori Therapeutics, San Diego) on-site. Following cell processing, the ADRCs were injected directly into the patient's heart muscle.

At the one-year mark, the ADRC treated patients with at least one class improvement in heart failure class (57 percent) and angina class (67 percent) tended to be higher relative to the placebo group (15 percent and 27 percent, respectively). Further, the cell-treated patients noted an improvement in the Minnesota Living with Heart Failure questionnaire (-21.6 vs. -5.5, p=0.038) and showed a trend toward relatively fewer heart failure hospitalizations (centrally adjudicated [2/17, 11.7 percent vs. 2/14, 21.4 percent]). There were no between group differences in LVEF or ventricular volume.
Dr. Henry noted that while ATHENA observed a small patient population, the results are promising and consistent with what was seen with PRECISE and should provide the foundation for a large phase 3 trial.

The study, designed to enroll 90 patients, was terminated prematurely due to three neurological events that prolonged trial enrollment, but were not cell related.

Dr. Henry reported that he received modest support from Cytori Therapeutics, the sponsor of the trial.

Dr. Henry presented "Final Results for THE ATHENA TRIALS: Autologous Adipose Derived Regenerative Cells (ADRCs) for Refractory Chronic Myocardial Ischemia with Left Ventricular (LV) Dysfunction" on Thursday, May 5, 2016 at 11:00 a.m. ET.

This study was simultaneously published online in Catheterization and Cardiovascular Interventions, the official publication of SCAI, at the time of presentation.

For more information about the SCAI 2016 Scientific Sessions, visit www.SCAI.org/SCAI2016

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ATHENA Results Released Today- May 5th 06 May 2016 07:24 #6920

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Dr. Henry noted that while ATHENA observed a small patient population, the results are promising and consistent with what was seen with PRECISE and should provide the foundation for a large phase 3 trial.


If I look at the endpoints of ATHENA II-

Primary Outcome Measures:
Treatment emergent serious adverse events (SAEs), major adverse cardiac events (MACE), arrhythmia assessment, change in cardiac function and symptoms, and resource utilization [ Time Frame: 6 and 12 Months ] [ Designated as safety issue: Yes ]
Safety endpoints include:
Treatment emergent SAEs
Arrhythmia assessment via Holter monitoring
MACE defined as cardiac death and hospitalization for heart failure
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


Its clear that safety was at the top because of the fact it was the first cardiac clinic with ADRCs in the US and MACE and arrhythmia are both key anyway in CHF. In MACE I do not get the math- [2/17, 11.7 percent vs. 2/14, 21.4 percent - 2/17 is 11.7% yes- but 2/14 is 14.3% what is right? 3/14 is 21.4% so that is most likely the mistake- in the MESO Phase II all the patients whether treated or placebo most ended back up in the hospital for all kind of events and patients were recruited from very sick CHF patients in both trials. In ATHENA- MACE defined as cardiac death and hospitalization for heart failure. So ONLY 2 and 3 patients from the groups had to go back into the hospital, within 12 months?? That is pretty good

Anyway- why not give the MVO2 comparison since that had statistical significance in the n=24 patients clinic PRECISE. Still they see the PRECISE results confirmed. One has more questions than answers from this write up. I hope we can lay our hands on some slides soon... :really:

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ATHENA Results Released Today- May 5th 06 May 2016 08:18 #6921

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Cytori Announcement-

Cytori ATHENA Trial Results Support Symptomatic Benefit From Cytori Cell Therapy
May 06, 2016
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ:CYTX) announced today the presentation of six and twelve month data from the ATHENA Trials at the annual meeting of The Society for Cardiovascular Angiography and Interventions. 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: 20 million cells, 28 patients; ATHENA II: 40 million cells, 3 patients]. The objective of the ATHENA program was assessment of safety and feasibility of Cytori Cell Therapy using the Celution® System 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.
A total of 31 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 prematurely due to the prolonged period of enrollment required. Enrollment was prolonged due to challenges in identifying suitable patients who met all inclusion/exclusion criteria and two trial enrollment delays related to safety reviews during the trial. ATHENA and ATHENA II trial data were combined for analyses.
Top line 12 month data revealed:
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) and 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 6 months post-treatment, incremental treadmill testing, left ventricular ejection fraction, left ventricular end-systolic volume and left ventricular end-systolic volume showed no relevant differences between groups. As per the protocol, echocardiogram and treadmill testing were not conducted at 12 month post-treatment.
Heart failure hospitalizations were reported by investigators in 3/17 (17.6%) and 5/14 (35.7%) of cell treated and placebo treated groups respectively.
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%)). Two non-cell related fatal events occurred during the trial in the Cytori Cell Therapy group (myocardial ischemia – day 2 post-procedure, decompensation of heart failure – day 291 post-procedure) with none in the placebo group.
“The ATHENA data suggest that a small volume fat harvest, followed by automated local processing, and intramyocardial delivery of autologous Cytori Cell Therapy is feasible and may be associated with symptomatic benefit in these patients. Although the sample is size is limited, the findings support feasibility and scalability for use of Cytori Cell Therapy for treatment of ischemic heart disease,” said Dr. Tim Henry, Director, Division of Cardiology, Cedars-Sinai Heart Institute, Los Angeles and one of the coordinating investigators for the ATHENA trials.

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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:

ATHENA Results Released Today- May 5th 06 May 2016 09:25 #6922

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All in all- these results are basically what was expected and are perfectly OK for this population of severe CHF patients.

I do understand why Calhoun and Perin want to pursue the opportunity. Surely there is a substantial placebo effect too- especially in the soft endpoints- so one could not have been sure that these would obtain statistical significance, but they did. That is good. With the back- and forth hauling for 4 hours as we heard what happened to these poor folks- also placebo would have had benefit from local endogeneous cells released upon injury to the heart. I know- sounds silly- but its true- just poking helps to a degree too.

Anyway- with the Okyanos knowledge (which is somewhat limited) and possible work which is not known by Cytori investors (of which there is plenty), I believe it is criminal- assuming Bernhard Lampert has found sufficient UAE money- to NOT develop the application NOW. Patients are in need thereof and cytori could use some support. :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:

ATHENA Results Released Today- May 5th 13 May 2016 19:33 #7008

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ATHENA Results Released Today- May 5th 14 May 2016 06:52 #7009

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Bottom line we need more data and larger trials. That takes time and money neither of which we have. We also can't get a partner that believes in this so trial has been dormant, for what 2 years. Time is money neither of which Cytori has. They had plenty of money but it has been mismanaged, wasted on over paying ineffective management that does not understand how to effectively navigate the process in order to generate any revenues. With the hundreds of millions of dollars spent, we should be more then an .18 stock adjusted for reverse split of course. Cost cutting too little to late so now management wants to without personal sacrifice which in my book is a primary characteristic of a true entrepreneur , and after having wiped out loyal long term shareholder who have financed this shit show for years to believe that this time will be different. Problem is you have shown nothing in your decision making or meaningful results, or acceptance by any partner to invest. As many have suggested. Why not put up your own god dam money first to show a belief in what your doing. The lip service and repetitive , empty conference calls are just st not enough. Managements last move as so many of us who took our time to meet and speak and pleaded not to do has blown up in there face, resulting in exactly what we warned. Pricing of your last rites offering is a joke and you will once again have to go back , look foolish and come to potential investor with your tail between your legs, hat in hand begging. Admit the errors, get the hell off Nasdaq, and come back to play with the big boys with a new Team up for the task.

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ATHENA Results Released Today- May 5th 15 May 2016 08:39 #7011

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Yes rothco...cardiac is dead. CC may try to kill it some more ....LOL
There will be work within the medical field and it will be ready to go as Cytori's patents expire.

>>>Pricing of your last rites offering is a joke<<<

LOL, Last rights offering !!! That is hysterical !!!!!! :grin:

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ATHENA Results Released Today- May 5th 15 May 2016 13:05 #7012

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rothco619 wrote: Bottom line we need more data and larger trials. That takes time and money neither of which we have. We also can't get a partner that believes in this so trial has been dormant, for what 2 years. Time is money neither of which Cytori has. They had plenty of money but it has been mismanaged, wasted on over paying ineffective management that does not understand how to effectively navigate the process in order to generate any revenues. With the hundreds of millions of dollars spent, we should be more then an .18 stock adjusted for reverse split of course. Cost cutting too little to late so now management wants to without personal sacrifice which in my book is a primary characteristic of a true entrepreneur , and after having wiped out loyal long term shareholder who have financed this shit show for years to believe that this time will be different. Problem is you have shown nothing in your decision making or meaningful results, or acceptance by any partner to invest. As many have suggested. Why not put up your own god dam money first to show a belief in what your doing. The lip service and repetitive , empty conference calls are just st not enough. Managements last move as so many of us who took our time to meet and speak and pleaded not to do has blown up in there face, resulting in exactly what we warned. Pricing of your last rites offering is a joke and you will once again have to go back , look foolish and come to potential investor with your tail between your legs, hat in hand begging. Admit the errors, get the hell off Nasdaq, and come back to play with the big boys with a new Team up for the task.


Even if some of the spelling is (purposely?) hilarious, the rest of it also concurs with my own sentiment after 15 years of XMPA (=CYTX) investment. I do think I was the first to suggest the OTC Board and I still do not think there is anything wrong with that- if PRESENT shareholders should finance the way forward, there is ABSOLUTELY no need for institutional investors at this point in time i.e. there is absolutely no need for Nasdaq at present. They can have our shares later at the proper value. :yep:

My suspicions on irregular behaviour and mismanagement at Cytori are growing day by day, despite the progress being made in the regulatory space. The stupidity of past actions just do not make sense and point to ulterior motives. :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:

ATHENA Results Released Today- May 5th 15 May 2016 13:51 #7014

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Fas, commit to join me in class action. Let's expose these incompetent bastards for what they are. If we expose it ,we ruin the final chapter which is to obviously steal the tech. With your support we will have a huge class.The time is now

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ATHENA Results Released Today- May 5th 15 May 2016 21:27 #7018

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Fat lady warming up ?

Remember, zero was always a possibility.

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ATHENA Results Released Today- May 5th 16 May 2016 07:07 #7021

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fas wrote:

rothco619 wrote: Bottom line we need more data and larger trials. That takes time and money neither of which we have. We also can't get a partner that believes in this so trial has been dormant, for what 2 years. Time is money neither of which Cytori has. They had plenty of money but it has been mismanaged, wasted on over paying ineffective management that does not understand how to effectively navigate the process in order to generate any revenues. With the hundreds of millions of dollars spent, we should be more then an .18 stock adjusted for reverse split of course. Cost cutting too little to late so now management wants to without personal sacrifice which in my book is a primary characteristic of a true entrepreneur , and after having wiped out loyal long term shareholder who have financed this shit show for years to believe that this time will be different. Problem is you have shown nothing in your decision making or meaningful results, or acceptance by any partner to invest. As many have suggested. Why not put up your own god dam money first to show a belief in what your doing. The lip service and repetitive , empty conference calls are just st not enough. Managements last move as so many of us who took our time to meet and speak and pleaded not to do has blown up in there face, resulting in exactly what we warned. Pricing of your last rites offering is a joke and you will once again have to go back , look foolish and come to potential investor with your tail between your legs, hat in hand begging. Admit the errors, get the hell off Nasdaq, and come back to play with the big boys with a new Team up for the task.


Even if some of the spelling is (purposely?) hilarious, the rest of it also concurs with my own sentiment after 15 years of XMPA (=CYTX) investment. I do think I was the first to suggest the OTC Board and I still do not think there is anything wrong with that- if PRESENT shareholders should finance the way forward, there is ABSOLUTELY no need for institutional investors at this point in time i.e. there is absolutely no need for Nasdaq at present. They can have our shares later at the proper value. :yep:

My suspicions on irregular behaviour and mismanagement at Cytori are growing day by day, despite the progress being made in the regulatory space. The stupidity of past actions just do not make sense and point to ulterior motives. :whistle:



FAS,

The way this world is going via social media, I'd bet Cytori could go to OTC and find investment cash from current shareholders via GOfundMe.com campaign !

Provided we the people set the salaries and bonus , of course

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