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TOPIC: Last patient visit in STAR trial has been logged

Last patient visit in STAR trial has been logged 23 May 2017 08:15 #9358

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Topline trial results announcement expected early Q3 2017

SAN DIEGO, Calif., May 23, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ:CYTX) ("Cytori" or the "Company"), today announced that it has now completed all 48 week follow up monitoring visits in its U.S. FDA approved Phase III STAR trial. A total of 88 subjects were enrolled and the last subject’s 48 week visit was conducted earlier this week.
STAR is a double-blind, randomized, placebo-controlled, parallel group phase III pivotal study investigating the efficacy and safety of HABEO™ Cell Therapy™on subjects with impaired hand function from scleroderma. The subjects were randomized 1:1 to either HABEO Cell Therapy or placebo. HABEO™ and placebo were administered subcutaneously in subject’s fingers. Final assessments were done at 48 weeks. Upon unblinding and evaluation of the data, subjects who received placebo will be offered participation into the crossover portion of the protocol, using HABEO™ Cell Therapy™, should they desire treatment and continue to qualify. Details of the STAR trial including inclusion and exclusion criteria can be found at the following link: clinicaltrials.gov
In the United States, the scleroderma affected population appears to be approximately 184 per million, which would represent a market size of aproximately 45,000 scleroderma patients.1 Additionally, in Europe, scleroderma is estimated to have a prevalence between 31 per million and 277 per million which equates to approximately 17,000 to 149,000 scleroderma affected people in the Europe.2

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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:

Last patient visit in STAR trial has been logged 23 May 2017 08:29 #9359

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Since the patient commitment is pretty relevant and now has been proven to exist i.e. the patients all came to their appointments...the mail question from the CC might be worth while repeating, since it is more relevant now..

Thank you, Ian. We actually have 2 e-mail questions that I'll address. The first question is about the precise timing with respect to the readout on the STAR trial, and can I be more specific about that other than Q3.

And what I can tell you about the timing is that, as I mentioned in the call, the 48-week or the last follow-up period is approaching soon, the 88-patient was randomized in June 2016. So you can do the math. And if the patients are on time to their appointments and there's been strong patient commitment to the trial and follow-up, as I've mentioned before, then as we've gotten closer and closer to data readout, we've narrowed the focus from Q3 down to early Q3. It could be before Q3 and it just depends on the mechanics of when that last patient comes in, how quickly we can clean the data, lock it, turn it and assess the statistical analysis. So we'll try to be conservative with an early Q3 date, but our goal would be to have that data in our hands as fast as possible, and then at that point, we'll get it out.


We will see how quickly they turn this, maybe also interesting to know- Cytori does not have to employ professional staticians to evaluate the clinical data- I did not know that before, but there is software on the market (I assume approved by the FDA) which basically can spit out the p-data for you, based on the parameters and patient data inputted.

I am optimistic on Q2. :winky:

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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:

Last patient visit in STAR trial has been logged 23 May 2017 08:52 #9360

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Binary event in 2 months!

I think the 24 month data is statistically significant - if so, the trend would be the same for the 48 month data readout.

It is very likely that in between now and the final STAR data readout (in the absence of negative news), the PPS may turn green for a change. The renewed BARDA contract may add more fuel to the rise.

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