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TOPIC: Scleroderma Trial Update

Scleroderma Trial Update 26 Oct 2016 08:30 #7822

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See press release as of 7:00am ET today - to present clinical trial data on Nov. 15th! :yep:

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Scleroderma Trial Update 26 Oct 2016 08:42 #7823

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rodney.strongg wrote: See press release as of 7:00am ET today - to present clinical trial data on Nov. 15th! :yep:


which read as follows:

Oct 26, 2016
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) will present data from its STAR Phase 3 clinical trial describing progress, preliminary blinded patient characteristics, and safety of adipose-derived regenerative cells (ADRCs) for treatment of scleroderma hand dysfunction (clinicaltrials.gov) at the Annual Meeting of the American College of Rheumatology on November 15, 2016.
The poster presentation will describe the STAR clinical trial procedures, patient characteristics, and preliminary blinded safety data for the use of Cytori Cell Therapy in scleroderma patients for the treatment of hand dysfunction. The proposed mechanism of action of the ADRCs prepared with Cytori’s Celution System is postulated to be modulation inflammation, promotion of angiogenesis and prevention of cell apoptosis. Studies suggest that ADRC therapy may change the inflammatory response and augments the regenerative response that starts early in the injury process.
The STAR clinical trial is an 88 subject, double blind trial comparing the effect of Cytori ECCS-50 therapy on hand function as measured by the Cochin Hand Function Score as compared to placebo. Other assessments include Raynaud’s Condition Score, Scleroderma Health Assessment Questionnaire (SHAQ), as well as other evaluations up to 48 weeks. Cytori ECCS-50 therapy is administered subcutaneously directly into the fingers.
“The preliminary data support the feasibility of using Cytori Cell Therapy in scleroderma patients with hand dysfunction,” said Dr. Dinesh Khanna, MD, MS, Frederick G.L. Huetwell Professor of Rheumatology and Professor of Internal Medicine in the Division of Rheumatology, director of the University of Michigan Scleroderma Program and lead author of the poster.
Dr. Marc Hedrick, President and CEO of Cytori, commented, “We remain focused on continuing execution and completion of the STAR study in the middle of 2017.”
Scleroderma, also known as systemic sclerosis, is an autoimmune disease that results in hardening of the skin. There is no known treatment for scleroderma. It is characterized by an excess production of collagen, damage to small blood vessels, and abnormal activation of T lymphocytes. The excess production of collagen may also affect internal organs including the lung, the kidney and the esophagus. The excess production of collagen and damage to blood vessels often results in swelling, skin tightening and breakdown of the skin in the hands causing an inability to perform normal daily activities.
The treatment of hand dysfunction in scleroderma remains an underserved medical need. There is no current approved therapy focused on the improvement of hand dysfunction in scleroderma.

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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:

Scleroderma Trial Update 26 Oct 2016 10:41 #7825

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FAS

This PR and the previous PR (on preclinical study on the combined thermal and radiation application) are both meaningful news.

1. Preclinical news: again, the IV dose administration yields equivalent results as the local doses This PR points to near term approval for the "IND", leading to phase I-II study in 3 centers in 2017. The safety data will lead to other niche phase 2 trials in other indications (and more partnership talks).

2. Dr. Khanna is the lead doctor in the STAR trial.

3. Safety data in the STAR trial is important, as the combination of cell therapy and cytoxan has many deaths in the Michigan and Northwestern study.

4. They have unblinded some data (such as the safety data) and Hedrick's comment re focusing this trial to compleiion, suggests they have a general idea re efficacy of the treatment arm.

5. I take another look at the OA 48 month clinical data (as previously released by CYTX): there is a significant seasonal factor (circadian rhythm) involved in the clinical results (just take a look at the pain medication pattern- consistently low for the treatment arm but up and down for the placebo with peaks in the winter and valleys in the summer, parallel with other bodily biologicals).

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Scleroderma Trial Update 26 Oct 2016 18:22 #7832

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>>>This PR and the previous PR (on preclinical study on the combined thermal and radiation application) are both meaningful news.<<<

Is that why the PPS moved exactly zero for each release ?
On pathetic volume as well. In fact we were in danger if not even hitting 20K in volume today the volume doubled in the last 20 minutes or so.

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Scleroderma Trial Update 26 Oct 2016 21:04 #7834

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Hedge, you are not wrong about the price performance of the stock. To say it is miserable is an understatement.
I fully participated in the latest shareholder capital raising and it is fair to say that I probably should not have. I would have been able to buy considerably more shares at these lower levels, but having said that, I am not sure that it would have been all that great for CYTX or the existing long suffering shareholders had we NOT invested.

All this aside, it is difficult to see what else management can do. The news to date has been positive and one would have expected a better response in the share price. It is what it is. After almost 13 years in this company (Macropore) I do not want them to give away the company just for the sake of making a deal.

Franshei is on to something important. The IV administration of ADRC for the upcoming burn trial on the basis of the pre-clinical animal studies was very significant.

1. We know that ADRC work when they are injected locally for scleroderma.
2. We know that ADRC work for burn via locally and systemically administered methods.

It is not a stretch that if systemic application works in burn, then it is entirely feasible that it could be able to treat systemic scleroderma and other autoimmune diseases such as rheumatoid arthritis etc.

Additionally we should not forget that OA was not a failure. We need to wait for the longer timeline assessment and MRI for final judgement/validation. If the data turns out to be positive then the ramifications could be profound.

The vast majority of the investment community has no idea about CYTX. It's past performance makes this entirely justified. The majority of players in our space are hedge fund arbitrageurs and front running investment bankers with their cronies.
Potential partners have every incentive to buy us during a moment of weakness, so they will not do anything to help unless they feel that they may lose an opportunity to a competitor. Most potential competitors have a huge investment in the status quo or alternative treatments, they want to see us bankrupt.

The financial interests allayed against us are huge, but we have one thing going for us. Man's desire to live long and be healthy. There is a huge number of researchers who are focusing on the stem cell space. Where there is smoke there is fire. I believe that Cytori could be that fire.

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Scleroderma Trial Update 26 Oct 2016 22:50 #7835

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test
There it goes again, another failed post that this time also signed me out.
Has to be ghost in the system.
Anyway rongside I did have a response...too lazy to retype. Nice post and I do agree with parts of it.

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Scleroderma Trial Update 26 Oct 2016 23:44 #7836

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Hedge, in the past I have also been signed out due to taking to long to respond. I suggest that you copy paste whatever you have written prior to trying to send it. That way if you are logged off you don't have to rewrite everything.

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Scleroderma Trial Update 27 Oct 2016 10:44 #7840

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maybe time was a issue rongside but I first tried to sign in using the log in link right next to your post and in let me sign in then bumped me right out before I could do anything. So the second time I went to the top of the thread and used the main log in. I was allowed to write my reply which probably did take about 15 min or so then lost it when tried to post. I have had that happen in the past but never signed out as well.
Anyway...3 weeks from now we will be digesting if any real news was given on the call.

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Scleroderma Trial Update 27 Oct 2016 11:09 #7841

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myownhedgefund wrote: maybe time was a issue rongside but I first tried to sign in using the log in link right next to your post and in let me sign in then bumped me right out before I could do anything. So the second time I went to the top of the thread and used the main log in. I was allowed to write my reply which probably did take about 15 min or so then lost it when tried to post. I have had that happen in the past but never signed out as well.
Anyway...3 weeks from now we will be digesting if any real news was given on the call.


Hedge-

I do have the session time set at 15 minutes, which is generally recommended by CMS developers. That means, that 15 minutes after arriving at a page on the site or in our case, when you click the button "reply" to write an answer, you have only 15 minutes to write your response, since the server will end your session after 15 minutes of inactivity (being defined as continuing to another page or hitting the post button). The server does not know that you are typing- if you get my drift...

So- actually Rongside´s method is what I do also when I know my response will be a bit longer as usual.:write:
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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:

Scleroderma Trial Update 27 Oct 2016 11:40 #7843

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Thanks Fas, I guess I will start copying my responses before trying to post as well

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Scleroderma Trial Update 27 Oct 2016 23:38 #7852

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Wrongside:

I believe many people may not understand the significance of the parenteral/iv dosing.

1. It is probably a major breakthrough in the celution technology (new patents on the way) in the form of CTX2, by which the end end product can be given without the danger of "stroke-like" side effects. Remember the cardio study, 2 patients experienced transient "stroke-like" effects - when the intramuscular doses may have spilled over into the general blood circulation. Now, this problem might have been effectively eliminated, without sacrificing the efficacy.

2. IV dosing is much, much more convenient and practical for the medical practice.

3. I do not believe CTX2 will fully replace celution 800 of which the end product is more viscous for local administration (Okyanos experiences clearly indicate that for knee OA local treatment, the injected cell mixture needs to stick to the bone and related region). I believe the use of celution 800 for plastic surgery cannot be replaced by CTX2. The two technologies have their own individual merits.

4. I think CYTX would be wasting money if new clinical studies for other niche indications are launched now, by employing just regional dosing. Once the safety for the IV dosing is established (BARDA phase I trial will be conducted in just 3 centers), CYTX will probably initiate new phase 2/3 trials.

5. The IV dose administration in new indications will draw in plenty of potential partnerships.

Just my own opinions. I can be totally off track.
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Scleroderma Trial Update 28 Oct 2016 05:53 #7853

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franshei wrote: Wrongside:

I believe many people may not understand the significance of the parenteral/iv dosing.

1. It is probably a major breakthrough in the celution technology (new patents on the way) in the form of CTX2, by which the end end product can be given without the danger of "stroke-like" side effects. Remember the cardio study, 2 patients experienced transient "stroke-like" effects - when the intramuscular doses may have spilled over into the general blood circulation. Now, this problem might have been effectively eliminated, without sacrificing the efficacy.

2. IV dosing is much, much more convenient and practical for the medical practice.

3. I do not believe CTX2 will fully replace celution 800 of which the end product is more viscous for local administration (Okyanos experiences clearly indicate that for knee OA local treatment, the injected cell mixture needs to stick to the bone and related region). I believe the use of celution 800 for plastic surgery cannot be replaced by CTX2. The two technologies have their own individual merits.

4. I think CYTX would be wasting money if new clinical studies for other niche indications are launch now, by employing just regional dosing. Once the safety for the IV dosing is established (BARDA phase I trial will be conducted in just 3 centers), CYTX will probably initiate new phase 2/3 trials.

5. The IV dose administration in new indications will draw in plenty of potential partnerships.

Just my own opinions. I can be totally off track.


Thanks for the post Franshei- should ignite some thoughts here and there..:grin:

I tend to agree with your points 2, 4 and 5. I do not think the cause of the minor strokes was related to a spill-over of the cells, which I believe was confirmed, but more the sheer emotional- and physiological stress of a >4 hour procedure with very sick people. You ask for problems like that and heavy atherosclerotic folks can sustain vessel ruptures under these conditions very easily. Hedrick and the Chief Medical Officer should have known that.

Your 3td point I find very interesting. It never crossed my mind that viscosity could play a role. I was more focussed on the difference in gentle gyrations of the centrifuge getting the cells into different "states".
I would appreciate it, if you have your thoughts confirmed by the scientific staff of Cytori. Min Zhu (This email address is being protected from spambots. You need JavaScript enabled to view it.) would be your best source- not only did she discover ADRCs according to Hedrick. She is also the brains behind CTX2.
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Scleroderma Trial Update 28 Oct 2016 08:30 #7854

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FAS, Thanks.

Min Zhu sounds like a lady scientist.

I used to correspond with Tiago Girao and I found him a nice guy, but virtually useless in terms of guidance. So, I write to Hedrick directly.

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Scleroderma Trial Update 28 Oct 2016 08:45 #7855

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franshei wrote: FAS, Thanks.

Min Zhu sounds like a lady scientist.

I used to correspond with Tiago Girao and I found him a nice guy, but virtually useless in terms of guidance. So, I write to Hedrick directly.


You should do what you think is best. I just suggested Min, since, I believe, your ancestors come from the same country and I know she is very friendly, modest, but highly competent. :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:

Scleroderma Trial Update 28 Oct 2016 10:15 #7856

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FLASHBACK: Remember the fiasco of the Celution ONE? It was going to change everything!

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Scleroderma Trial Update 28 Oct 2016 10:15 #7857

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FAS

The recent trading volume is very, very low and the PPS is virtually unattractive. I think it is related to lack of "real" news.

Early September, Hedrick presented at the Rodman and Renshaw meeting and the preview of forthcoming release calendar was not much on the plate: 3 major items and it seems that people are either not believing them (because of past track record) or taking them lightly before the actuality.

The 3 items are: 1. OA partnership discussion and Hedrick mentioned that 2 were meaningful leads to possible near-term fruition. 2. BARDA FDA "IND". 3. Under BARDA, "Orphan drug designation" - strange to me, why BARDA thermal and radiation damage claims, why not scleroderma claim?

I think if the OA partnership would happen (Hedrick sounded real in his presentation), the PPS should go up, when it happens.

Regarding the OA partnership, it may not be necessarily the list of potential medical device companies that you have listed. The potential parties may be other biotech/device type companies with strong interest and know-hows in OA - companies that recognize the real value of the current CYTX OA clinical data, that is. "it works", but the further studies should be managed in a "different way with different end points for FDA approval". In other words, the CYTX OA study would be great/greater in the hands of a different party (Kesten was not up to the job?).

(I think Harris and Marino the two recent new additions to the company are probably good. Just look at Harris, he has not kicked out Lorem yet. Please refer to the CYTX Products column. Lorem is still there -the setup in China may still have value to Harris and Lorem is selling Celase, a new item for them.)

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Scleroderma Trial Update 28 Oct 2016 13:06 #7858

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Franshei, don't be afraid, call the woman as Fas suggested - could be meaningful for all of us!:nice: :yep: :yep:

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Scleroderma Trial Update 28 Oct 2016 19:22 #7862

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Franshei
If a OA partner should come who is to say they don't have to start all mover again with a phase 2 ?

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