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TOPIC: Press Release Re STAR

Press Release Re STAR 07 Nov 2017 08:38 #10430

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STAR trial data accepted for presentation at Systemic Sclerosis World Congress on Feb. 15 -17 in Bordeaux, France - Habeo cell therapy for hand dysfunction due to systemic scleroderma.

PS - I see no mention of status with FDA.

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Press Release Re STAR 07 Nov 2017 09:31 #10431

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Press Release Re STAR 07 Nov 2017 09:40 #10432

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Thanks B-7, I forgot that Fas likes a reference to the source.

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Press Release Re STAR 07 Nov 2017 10:30 #10433

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rodney.strongg wrote: Thanks B-7, I forgot that Fas likes a reference to the source.


Rodney- yes, I do like links or references in case of news or info quoted from "outside sources". When an announcement from Cytori themselves is involved, I think the text of the announcement is more appropriate, since one can read it right away and discuss contents, if needed. So -here the text:

SAN DIEGO, Nov. 07, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (Nasdaq:CYTX) (“Cytori” or “the Company”) announced today that its U.S. STAR clinical trial assessing the safety and efficacy of Habeo™ Cell Therapy for hand dysfunction due to systemic scleroderma (SSc) has been accepted for presentation at the 5th Systemic Sclerosis World Congress on February 15-17, 2018 in Bordeaux, France.

The presentation will include a full data analysis, beyond the top-line results previously reported by the company in July and October 2017, specifically:

  • While there were trends toward greater improvement in the primary endpoint, Cochin Hand Function Score [CHFS], for Habeo compared to placebo at 24 and 48 weeks, for both time points these differences did not achieve statistical significance of p≤0.05.

  • The pre-specified analysis of 51 subjects with diffuse SSc showed a clinically meaningful treatment benefit at 48 weeks in both the CHFS (improvement of 12.0 points for Habeo compared to 6.6 in the placebo group) and in a secondary endpoint, the Health Assessment Questionnaire Disability Index [HAQ-DI] (improvement of 0.21 points compared with 0.04 in the placebo). These differences approached or achieved statistical significance (p=0.069 and p=0.044, respectively).

  • Subsequent data analysis of these and other key endpoints in patients with diffuse SSc are also consistent with a treatment effect:

  • Responder analysis for the HAQ-DI score at 48 weeks, based on published minimal clinical important differences, showed that 63% of patients in the Habeo group had a clinically-important improvement compared with only 26% of patients in the placebo group (p=0.019)

  • A standardized measure of health-related quality of life, EQ-5D, showed that 50% of patients in the placebo group exhibited clinically-important worsening at 48 weeks compared to only 3% in the Habeo group (p=0.0002).

  • Patients in the Habeo group, compared to the placebo group, also exhibited a reduced number of new ulcers over the 48 week study period (mean 1.72/patient compared with 3.74/patient in the placebo group; p=0.178), delayed time to first new ulcer (p=0.116), and greater improvement in hand mobility at 48 weeks, as measured by 2nd-4th corner distance of right hand (~5.5 mm increase vs. ~0.6 mm decrease, respectively; p=0.135).

  • The full data set will be presented at the 5th Systemic Sclerosis World Congress on February 15-17, 2018.
    STAR was a randomized, placebo-controlled, double-blind, parallel group, U.S. clinical trial intended to study the safety and efficacy of Habeo Cell Therapy in 88 subjects with hand dysfunction due to scleroderma at 19 U.S. centers. Cytori is currently working with statisticians and study investigators in preparation for publication of these results in a peer-reviewed journal.

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    Press Release Re STAR 07 Nov 2017 10:30 #10434

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    Rodney

    1. As I have said many times, CYTX should continue to rerieve followup data beyond 48 weeks. Indeed, this is what they are doing. At the time of this PR, the 72 week data is not available yet. But, it is coming and it should be ready for the Feb meeting.

    2. The current STAR data for the diffuse cutaneous scleroderma is very good indeed and it would look better with time. At the pending FDA meeting, CYTX still have a decent chance to do a filing - the probability is great data if the new 72 week data (not yet available, but if it is good, CYTX can request to file "NDA") and if the French Sclerodec 2 data is also positive (not yet available till mid 2018).

    3. The wrong assumption in the planning of the STAR protocol is: Habeo should work in early stages of scleroderma-wrong, with the study results. It works in between early and late stages (clearly pointed out in Takafumi Hiranaka's website for cell therapies in his clinic). Thus, the plan for the Raynauld's P will not proceed forward

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    Press Release Re STAR 07 Nov 2017 10:46 #10435

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    franshei wrote: Rodney

    1. As I have said many times, CYTX should continue to rerieve followup data beyond 48 weeks. Indeed, this is what they are doing. At the time of this PR, the 72 week data is not available yet. But, it is coming and it should be ready for the Feb meeting.

    2. The current STAR data for the diffuse cutaneous scleroderma is very good indeed and it would look better with time. At the pending FDA meeting, CYTX still have a decent chance to do a filing - the probability is great data if the new 72 week data (not yet available, but if it is good, CYTX can request to file "NDA") and if the French Sclerodec 2 data is also positive (not yet available till mid 2018).

    3. The wrong assumption in the planning of the STAR protocol is: Habeo should work in early stages of scleroderma-wrong, with the study results. It works in between early and late stages (clearly pointed out in Takafumi Hiranaka's website for cell therapies in his clinic). Thus, the plan for the Raynauld's P will not proceed forward


    Although I agree with your comments- I believe longer term follow-up would exclude placebo, since at the 48 months point, I believe the placebo patients could opt for the "real thing"?

    On 3- Raynaud´s. Actually I am still lost on the STAR data compared to Scleradec I. In France at 24 and 48 weeks the improvement was good but not gigantic- 30 to 40% if I recall right. Only at 3 years - i.e. 160 weeks that percentage was over 90%, so only works fantastic long-term. I wonder why that is- my guess is that STAR treated a lot of pre- and real diabetics, contrary to France, where folks eat much less processed food and sugar and are healthier from a metabolic perspective. High blood insulin creates heaps of endothelial dysfunction in the arterioles or the tiny blood vessels leading to the fingers.

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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:

    Press Release Re STAR 07 Nov 2017 15:05 #10436

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    Franshei, good post - do you plan to participate in the RO?

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    Press Release Re STAR 07 Nov 2017 17:07 #10438

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    Fas, you may find this interesting:

    www.ncbi.nlm.nih.gov/pmc/articles/PMC5442303/

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    Press Release Re STAR 08 Nov 2017 06:01 #10439

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    myownhedgefund wrote: Fas, you may find this interesting:

    www.ncbi.nlm.nih.gov/pmc/articles/PMC5442303/


    Yeah, thanks- that was interesting. Basically the opposite what I was arguing, since type 1 is the situation where the pancreas is unable to produce any or at least sufficient insulin to guide the glucose uptake into the cells what the hormones are meant to do- that is why those folks constantly have to control their blood glucose and add insulin if the level goes up too high.

    My argument is supported by many papers- this one for instance- HERE
    The problem being that Type 2 is recognized only at a stage when things are too late and difficult to reverse. That is why they call Type 2 a progressive and irreversible disorder- which in my mind is bull shit and a big lie. One of many.
    Reason is that generally only fasting blood glucose and high Hemoglobin A1C are taken as decisive markers, instead of fasting insulin. Before that former diagnoses however, the cells become insensitive for insulin driven glucose uptake and liver and pancreas are slowly-, but surely destroyed by producing more and more insulin to get the blood glucose down. This is where endothelial dysfunction also has started and is difficult to heal.

    My bet is that beyond the 30% of the population with T2- a much bigger percentage is undiagnosed T2 or at least pre-diabetic. The AHA and American Diabetic Association, as puppets of the pharma industry like it that way, since it brings them customers. In the end it will ruin the health care systems though.

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    Press Release Re STAR 08 Nov 2017 15:03 #10441

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    Well...it certainly seems to me that if they need to run another full p3 trial (which I believe they will have to) there is really going to be a screening challenge.

    The NO part of the paper you provided was interesting as the therapy is used today for patients from premature babies to adults.. although usually started far too late for the latter.

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    Press Release Re STAR 08 Nov 2017 19:13 #10442

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    rodney.strongg wrote: Franshei, good post - do you plan to participate in the RO?


    You buying into this Rod? Last one turned out to be a sucker play which I’m sorry to say included me.

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    Press Release Re STAR 09 Nov 2017 01:19 #10443

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    b7
    Sorry to hear you lost out on the last RO but it was discussed here that it wasn't structured as friendly to shareholders even if STAR didn't fail. (of course that would be opinion)
    This RO is inventive, I'll concede that but it is also clear that more funds will be needed.
    While we still hover around $0.40 I do find it interesting that support is minimal just before Hedrick's CC push.
    I did get a email on the RO from my broker yesterday...no calls yet. Last RO I think I got 3 calls...all ignored of course.
    Tomorrow I expect a picture painted the old world masters would appreciate...LOL Of course the art world has many fakes so one must be quite careful.
    This RO will close soon enough and then we can see how the street really plans to value CYTX.

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    Press Release Re STAR 09 Nov 2017 04:01 #10444

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    myownhedgefund wrote: The NO part of the paper you provided was interesting as the therapy is used today for patients from premature babies to adults.. although usually started far too late for the latter.


    Yes- improving NO function restores endothelial/vascular elasticity. As you might have read somewhere- I personally had severe atherosclerosis from a rather young age- 30-35 or so, which led at a later age to severely impeded walking ability- i.e. the so called "claudicatio intermittens" or PAD.
    After about a 2,5 years of sugar and carbs heavily restricted lifestyle (no diet- so I have regular intake of required calories for my age and size- BMI 26 now) I recently had my adiponectin measured- a hormone secreted by adipose tissue - which is a marker of Insulin resistance AND atherosclerosis- came in very satisfactory (>10) so am making big strides.

    I also think my regular intake of 5 grams of L-Arginine and L-Taurine (both amino-acids, which are the building stones of proteins) helps tremendously to restore NO function - including libido. :grin:

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    Press Release Re STAR 09 Nov 2017 08:33 #10445

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    b767cpt wrote:

    rodney.strongg wrote: Franshei, good post - do you plan to participate in the RO?


    You buying into this Rod? Last one turned out to be a sucker play which I’m sorry to say included me.


    B-7, it's always a risk, but if you believe the SP is cheap at .40, why wouldn't any CYTX investor (assuming they had the funds) buy into this RO?? Of course, I would wait to hear the CC today, but I doubt that will change the decision.

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    Press Release Re STAR 09 Nov 2017 08:43 #10446

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    Sounds like you are really on top of your health Fas....that's great.

    I am getting way off topic here but you may like this short article Fas.
    draxe.com/leaky-gut-diet-treatment/

    Even further off topic it is amazing the number of people I know who have been diagnosed with MS in the last 5 years or so. Autoimmune disorders really seem on the rise and seems far more than we have a aging population. Something out there seems to be going on.

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