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TOPIC: Total Confusion- Scleradec II Results and Next Steps

Total Confusion- Scleradec II Results and Next Steps 22 Nov 2018 13:59 #12364

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Only a bit more than 3 months ago- at the Q2 call- Cytori was still rather optimistic on Scleradec II to deliver results to file for conditional approval with the EMA, but now suddenly positive data from this trial coupled with STAR results (diffuse scleroderma only of course) would suddenly not be sufficient for this possible scenario.
Very strange- as noted before Management is down-playing the chances of success in this application very considerably, although they claim, they just know that a large portion of the treated population had limited disease - i.e. the less advanced version of scleroderma compared to diffuse.

There are observations to be made, where these conclusions all make very little sense and will write a few posts which kind of raises those questions in the next few days- at this point in time I just want to quote the spoken word at the last CC- i.e. the Q3 CC of a few days ago.

Prepared Statement: As previously mentioned, there is a smaller version of the U.S. STAR trial, the trial is not powered for efficacy. And furthermore, we now know that the majority of the enrolled patients, about 63%, 25 out of 40 enrolled, have a limited disease. However, if we exhibit positive EU data trends, this data, coupled with STAR trial data, may be insufficient to file or consider filing for conditional EU approval for this orphan indication in Europe. Our plan is to evaluate that once the data set is fully available to us.

Kolbert : I got a bunch of questions for you, guys. First, can you talk a little bit about what the EU filing for scleroderma might look like, and what the implications are for driving the U.S. program? Previously, I had those programs in kind of synch. And it looks to me like if something is going to happen in Europe, it will happen way ahead of the U.S. So help me understand the timing for ADRCs in Europe versus the U.S.
Hedrick: Jason, so with respect to the European trial, remember there's 2 parts to that trial. The first is the data as it relates to safety and efficacy and has the 3 and 6 months, and that will be the initial readout and the expectation is we'll get that by the end of the year. That's an investigator-initiated trial, as I mentioned. For now, we don't have the same line of sight in terms of timing, but we would have -- certainly the Cytori-sponsored trial. But that's the timing there. There's also a second set of data that we're expecting from that which is the data on the cryopreserved. Recall that in that trial, the patients that were randomized to placebo, we'll give another of that with cryopreserved cells and the data would be coming downstream from that. So the thing that could potentially drive a decision to push this forward in Europe would be once we get the 3 and 6 months data. I mean, based on that, we'll just play -- react to the data. It's hard to know at this point where that will go until we get the data. And also we would suppose that if we do, do this thing, it'll be packaged with the data that we've already collected in STAR in the U.S.


More to follow :whistle:

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Total Confusion- Scleradec II Results and Next Steps 22 Nov 2018 15:15 #12365

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Agree Fas..very confused. it seems earlier they thought patient stratification favoured those with more tougher disease in France where Star US showed better efficacy..now it seems they are downplaying. I can only hope market takes any new data on upside and they cross one dollar or close to raise cash. Not putting much faith long term in this indication sadly for patients.

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Total Confusion- Scleradec II Results and Next Steps 23 Nov 2018 10:23 #12367

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SH wrote: Agree Fas..very confused. it seems earlier they thought patient stratification favoured those with more tougher disease in France where Star US showed better efficacy..now it seems they are downplaying. I can only hope market takes any new data on upside and they cross one dollar or close to raise cash. Not putting much faith long term in this indication sadly for patients.


Yeah- they now claim the kill-all "not powered for efficacy" argument, which I hardly buy-in to. Also small trials can show SS and instead of saying " this data, coupled with STAR trial data, may be insufficient to file or consider filing for conditional EU approval for this orphan indication in Europe." it simply may as well be sufficient, assuming you do not know already that it isnt.

The main argument - because of the STAR data of course- seems to be their statement that 63% i.e 25 of 40 patients in the clinic had limited disease. But than again if you look at Magalon´s paper of SCLERADEC I at the 1 year point- it says when discussing population,

Twelve females with a mean age of 54.5 years (S.D. 10.3, range 34.068.0) were assessed 1 year after ADSVF injection. The population mainly included patients with limited cutaneous SSc and without severe organ damage

At one year - the results were already impressive-
Results. A significant decrease from baseline of 51.3% (P<0.001) for Cochin Hand Function Scale score,
63.2% (P<0.001) for RP severity and 46.8% (P = 0.001) for quality of life (Scleroderma Health Assessment
Questionnaire) was observed. A significant improvement of finger oedema, skin sclerosis, motion and
strength of the hands and of the vascular suppression score was also noted. The reduction in hand
pain approached statistical significance (P = 0.052). The questionnaire revealed a benefit in daily activities,
housework and social activities.


The paper I attach-

File Attachment:

File Name: 2016-Scleradec-I.pdf
File Size: 166 KB


The results after 3 years simply improved even further- especially the Raynaud´s score impressed me greatly. To be honest I still do not know what they have done in the US with STAR- it is simply unreconcilable- here those 3 years numbers from the abstract- (the paper cost money)

Results
Multiple patient-reported outcomes showed sustained improvement, in comparison with the assessment performed just before surgery: 62.5% in the Cochin Hand Function Scale, 51.1% in the Scleroderma Health Assessment Questionnaire, 33.1% in hand pain, and 88.3% in the Raynaud Condition Score. A decrease in the number of digital ulcers number was noted. Mobility, strength and fibrosis of the hand also showed improvement. None of the 8 patients who had previously received iloprost infusion required new infusion.


more to come in the weekend
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Total Confusion- Scleradec II Results and Next Steps 26 Nov 2018 06:17 #12370

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Let me start by writing that on that July date in 2017, when the STAR results were announced, I did not listen at all to the explanations given in the ensuing call. A world- more or less- collapsed that day, although I had received predictions to that disastrous effect already from former Cytori employees and the secondary in April 17 at rock bottom prices, should have been a shining bright red light.

I wouldnt have believed those explanations anyway whatever they were and I still dont trust the numbers, especially the one showing the results from the patients with limited disease in the population- see slide below. Of course - when a compound or therapy is not effective, initial results may not hold or deteriorate. That sure happens, but not that a placebo treatment actually improves only over time, beating treatment by some lenght. That just smells heavily, especially considering Scleradec I and everything started out OK at 6 weeks, but after that 6 weeks point-to me- it MAY very well have occurred, that the patients who showed improved results at the 6 weeks point in time have been brainwashed by the medical establishment and vice versa.



Anyway- I have been following this colorful world of "modern conventional medicine" now already for almost 15 years. At the beginning it looked really exciting and I even followed everything at , for instance, the AHA very closely. In particular, all the razamatazz surrounding CVTX, which developed Ranolazine (Ranexa- an anti-anginal product) and which I owned until the company was acquired by BP. At the same time, I could watch for signs within the organization itself (as being a AHA member) for early adaption of Cell therapy within the ranks of the AHA and its well-funded members.

On a personal level, I always have been a dedicated follower of all conventional pills and medication, until I realized from cardiac intervention, type 2, cancer treatment etc etc – call it simply metabolic syndrom , that I might be following the wrong pathway and probably just in time (I am still alive and rather healthy now compared to 3-4 years ago) switched to naturopathy, with limited concessions to the pills-world.

The process I went through and the many scientific studies I have read the past few years, which come in many cases to totally different conclusions than present standard of care, WITHOUT ANYTHING CHANGING IN THE MEDICAL WORLD, have made me very suspicious and critical on everything going on. For that reason I now even dare to write things like the line in red above. I really lost confidence in the integrity of most of the medical establishment and prefer to do my own research and due diligence for what is best for me.

Clearly I am not alone- there are thousands of scientists, who express their doubts, including former editors of prestigious medical journals, as you can read in this slide taken from a presentation in front of the European Parlament, done by an esteemed cardiologist in the UK- Dr. Aseem Malhotra.



Should make you think twice before relying on controversial studies.
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Total Confusion- Scleradec II Results and Next Steps 26 Nov 2018 10:19 #12371

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In layman’s terms please Fas, are you beginning to believe that this has been a major scam?

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Total Confusion- Scleradec II Results and Next Steps 26 Nov 2018 12:53 #12372

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b767cpt wrote: In layman’s terms please Fas, are you beginning to believe that this has been a major scam?


B7- With "this" you mean Cytori? If you do- my answer would be an emphatic NO. No scam.

The inherent issues lie - in my view - with corporate interests by BP, which largely controls the FDA and the established medical establishment. Nowadays you apparently can lose your insurance coverage, if you do not want a pill a doctor prescribes you, although you (might) know it doesnt do you any good.
It all started out "honestly" after WW II I think, but things turned sour on wrong medication and food stuffs.

Simply said- take a look at pictures of people walking on Time Square in the 30ties and now. The difference will tell you what went wrong and to keep the buck rolling it has to stay that way, which also COULD mean, sabotaging disruptive technologies, which could change things.
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Total Confusion- Scleradec II Results and Next Steps 28 Nov 2018 07:19 #12375

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It is so depressing to see a treatment paradigm with so much potenial effectively cease to exist. Perhaps the IP will be sold off or the company taken private, who knows? I have lost a lot of money which I do not expect to ever recoup.

I don't mind that so much, as the fact that autologous ADRC could/should be doing a world of good to patients around the world yet it is not. We have Tigenix/Takeda getting approval for the IP protected allogeneic treament of fistula yet it is being held back due to cost considerations. Perhaps the autologous model could produce the same benefits at a fraction of the price ........... God forbid........... BP cannot tolerate such an outcome, or survive it.

I would not shed a tear for my financial loss if the technology ended up in the hands of public sector institutions that ran with it, Unfortunately though the system is not geared up to work that way. Today we are experiencing a breakdown in the ability to provide effective healhcare at a reasonable price because the model dictates huge bureacracies and managing sickness no treating it.

Fas could you elaborate on your comment about Times Square.... I am not sure I understand what you are inferring.

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Total Confusion- Scleradec II Results and Next Steps 28 Nov 2018 09:56 #12378

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rongside wrote:
Fas could you elaborate on your comment about Times Square.... I am not sure I understand what you are inferring.




Compare the body compositions.

From the top of my mind- nowadays >30% of Americans are obese- (BMI >30) and officially about 20% have Type 2. In a private conversation after my CAC scan in April a senior doctor told me, as a rule of thumb, they consider all folks with a BMI >27 to be insulin resistant- = diabetic, whether diagnosed or not.
Reasons- processed food, sugar and vegetable (omega 6) oils in excess quantities, instead of natural mineral dense food stuffs. I changed- I was >35 BMI- now I am 25.
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