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TOPIC: STAR Results Announced

STAR Results Announced 24 Jul 2017 07:16 #9621

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Cytori Announces Top-Line 24- and 48-Week Results from the STAR Trial of Habeo™ Cell Therapy in Patients with Scleroderma

Jul 24, 2017
Statistical significance not achieved in primary or secondary efficacy endpoints
Clinically meaningful efficacy trends observed in primary and secondary endpoints in pre-specified diffuse cutaneous scleroderma subgroup
No significant safety related issues
Conference call scheduled for 8:30am EDT
SAN DIEGO, July 24, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ:CYTX) today announced top-line, preliminary data from its pivotal STAR trial of HabeoTM Cell Therapy in patients with scleroderma. While the primary endpoint, Cochin Hand Function Score (CHFS), did not reach statistical significance at 24 or 48 weeks, the trial data reported clinically meaningful improvements in the primary and secondary endpoints of both hand function and scleroderma-associated functional disability, for Habeo treated patients compared to placebo, in a subgroup of patients with diffuse cutaneous scleroderma.
The U.S. multi-center STAR trial enrolled and evaluated 88 patients with scleroderma, including 51 patients within the diffuse cutaneous subset and 37 with limited cutaneous scleroderma. In the combined study population, the primary endpoint, specifically mean improvement in the Cochin Hand Function Score, did not show statistical difference between treated patients and those receiving placebo at 24 weeks and 48 weeks as determined by both analysis of covariance and mixed model repeated measure analysis.
The Raynaud’s Condition Score, a secondary endpoint, improved in both the treatment and placebo group but was not statistically different between the Habeo treated and placebo groups.
However, in the pre-specified subgroup analysis of patients with diffuse cutaneous scleroderma, a more severe form of the disease, improvements in the Cochin Hand Function Score and the Health Assessment Questionnaire-Disability Index (HAQ-DI), a measure of functional disability and an important secondary endpoint, met or exceeded the published criteria for minimally important clinical differences in these measures (6.5 points for Cochin1, 0.22 points for HAQ-DI2).


“The safety and efficacy results from this trial in the diffuse subset of patients with scleroderma are impressive and represent important new information for the field,” said Dinesh Khanna, MD, Frederick G.L. Huetwell Professor of Medicine and Director of the University of Michigan Scleroderma Program. “The STAR trial suggests that Habeo may provide clinically meaningful improvements in the hand function and functional disability to patients with diffuse form of the disease who have no other treatment options. The diffuse subset has a more severe disease burden with significant hand dysfunction and internal organ involvement as well as the highest mortality rate among all rheumatic diseases. It is important for these patients that this innovative technology moves forward in the clinical and regulatory process.”
“We are disappointed that the study missed the primary and secondary endpoints. However, we are very encouraged by the trends toward improved hand function and scleroderma-related health status in patients with diffuse cutaneous scleroderma,” said Marc H. Hedrick, MD, President and Chief Executive Officer of Cytori Therapeutics, Inc. “We thank the STAR investigators and patients for participating in this trial, which has yielded new insights into scleroderma and shows yet again that discrete patient populations may respond differently to investigational therapies – an important consideration for individuals currently lacking treatment options for rare diseases. After we review the complete data set, we will work collaboratively with our team, trial investigators, patient advocates and the regulatory bodies in our key markets, to chart the next steps for this therapy.”
In general, the adverse events were rated as mild to moderate in the majority of cases and there were no significant safety issues identified for Habeo or the procedure itself (including liposuction and finger injection in the placebo group) during the trial.
“We are pleased with both the efficacy trends as well as the safety profile of Habeo,” said Dr. Mark Marino, MD, Senior Vice President and Chief Medical Officer of Cytori Therapeutics, Inc. “Following the evaluation of the full STAR data set, Cytori, in conjunction with the investigators, intends to submit the full data set, as a late-breaking abstract, to the American College of Rheumatology meeting in November 3-8, 2017. Simultaneously, we anticipate seeking a post-trial meeting with FDA as soon as possible to define next steps. We further plan to continue to support the investigator-initiated SCLERADEC-II trial in France, which is over 50 percent enrolled.”
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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:

STAR Results Announced 24 Jul 2017 07:27 #9622

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Just baffled and speechless at present.

Will need to absorb first.

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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:

STAR Results Announced 24 Jul 2017 07:41 #9623

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CYTX nanomedicine moves to the center stage.

We should now view cytori cell therapy as adjuvant therapy - it does not work by itself.

In the BARDA trial, CYTX cell therapy is considered adjuvant. Likewise. it should may work in OA and scleroderma in combination with other main stay therapies/medicine. In the case of scleroderma, the STAR data strongly suggest that it would work in combination with cytoxan or liposomal cytoxan.

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STAR Results Announced 24 Jul 2017 07:45 #9624

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“Scleroderma is a very complex disease but shares common features with other connective tissue disorders that may be attractive future targets for the therapy.” Like I said, the "but" was the give away. I've also mentioned the anticipated failure numerous times on this board. Franshei, nanomedicine is just the next carrot hung for folks like you. Buy more shares -- it will serve their purpose fabulously.

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STAR Results Announced 24 Jul 2017 07:54 #9625

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This is definitely surprising. Is the main trial investigator for the smaller trial a fraudster? The secondary endpoint was very close, but that is not relevant now.

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STAR Results Announced 24 Jul 2017 09:06 #9626

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Looks like my moniker ''rongside'' remains appropriate. Totally unexpected results. Do not know what to expect from an invesment point of view going forward apart from an almost total loss (substantial) :cry:

In retrospect, we can now assume that going forward everyone will be aware of a placebo effect, not only in OA but scleroderma also. Perhaps the French can try to increase the number of patients with diffuse cutaneous scleroderma in their trial? Even so it will not make much of a difference wih regard US FDA decision.

No one thought to ask about placebo effect:bash: Trial design is all. Not having had a proper phase II meant we did not anticipate this outcome.

I can only hope that the promise of ADRC is realised one day so that it may at least help patients .......... I however will not be funding it.

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STAR Results Announced 24 Jul 2017 09:45 #9627

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"We further plan to continue to support the investigator-initiated SCLERADEC-II trial in France, which is over 50 percent enrolled.”

How does Hedrick propose funding this?
I would like to be optimistic on this but it's beginning to look like flushing good money down the toilet.
WST called it right on the Yahoo board, with no short term prospects, they are probably done.

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STAR Results Announced 24 Jul 2017 09:52 #9628

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FAS

In March or so before the first Q CC, John Harris was interviewed by Xconomy and he downplayed the Cytori Cell therapy as a small segment of the company (activities mostly in Japan), with more emphasis in nanomedicine. Now, this article become prophetic. Actually all the recent hirings are all for San Antonia.

The appointments of Marteli and Lapointe and the financial backup from Lincoln Park point to the importance of the nanomedicine from here on. Cytori cell therapy should now play a lesser role.

I think Hedrick (but not Tiago Girao-he has done a great job as CFO) should step down, replacing by a real pharma man.

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STAR Results Announced 24 Jul 2017 09:58 #9629

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"I think Hedrick (but not Tiago Girao-he has done a great job as CFO) should step down, replacing by a real pharma man."

Perhaps you would be willing to step up to the plate Franshei? At this point, you would definitely have my vote!

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STAR Results Announced 24 Jul 2017 12:52 #9635

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What's Kolbert smoking? He's still pushing a $10 target.
Maxim has lost credibility with me.

finance.yahoo.com/news/analysts-remain-buyers-2-volatile-155411871.html?.tsrc=rss

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STAR Results Announced 24 Jul 2017 14:09 #9636

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Kolbert is a fool as made apparent by his rankings and success rates. He's referencing a statement Hedrick made regarding a likelihood of approval based on the FDAs Expedited Access Program or EAD:

"The regulatory pass in the U.S. for this product will be as a PMA premarket approval as a Class III device. One note I'd like to make as we been asked a number of times about various alternative regulatory pathways for this product. A regulatory path we think potentially may be available to us for Habeo is the FDA's new expedited access program or EAP. The EAP eligibility extends to devices that treat life-threatening or debilitating diseases that currently have no effective alternative treatments. In its guidance documents for the program, the FDA notes that it may accept less certainty regarding the benefit to risk profile of EAP devices subject to a PMA at the time a premarket approval and a proven EAP device as long as the data still supports a reasonable assurance of safety and efficacy.

The first step will be to apply for and obtain EAP designation from the FDA which is currently under consideration here at Cytori. If we choose to pursue this pathway and are successful, despite eligibility for early approval as compared to the standard PMA approval process, we would be subject to post market study requirement until ultimately the data from the trial will ultimately drive our decision-making process regarding the appropriate path."

Clearly they've been planning for bad data for awhile ...

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STAR Results Announced 24 Jul 2017 14:19 #9638

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I cant believe JK had even the smallest amount of credibility with you...LOL
Just pumping for the next raise.

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STAR Results Announced 24 Jul 2017 14:29 #9639

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"Just pumping for the next raise."

No more from me!
I was optimistic with this from the French phase 1 and now highly suspicious of the results from that. Hedrick already pumping the French phase 2 with only a 50% enrollment. Where does he plan on getting the money for this unless they get some positive news on something else and soon? Leads me to believe that they knew the data was coming up short and thus that last ludicrous stock offering.

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STAR Results Announced 24 Jul 2017 14:30 #9640

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"the FDAs Expedited Access Program or EAD:'

Moot point now.

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STAR Results Announced 24 Jul 2017 14:47 #9642

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Yeah, look how long it has taken for the SUI trial to enroll.
What will the report for sales in Japan for Q2 ???
I have been very critical of what they have shown through BARDA through the years. Now, if they ever run the next trial it will have real control of SOC vs BS like spraying on lactated ringers.

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STAR Results Announced 24 Jul 2017 16:12 #9644

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Hedge,
Did you listen to that conference call? A bunch of hindsight "if only"!
51 patients showed stat significance and they feel that stat significance would have been achieved with a larger patient sample?!?! Why didn't they have this figured beforehand?
Better understanding of what to look for in next trial in terms of patient qualification and sample size? Moot point now my friends. They should have taken the normal course and gone with a phase two here since the French trial did not include placebo.
Hedrick and his crew are really coming across as quite amateurish in this.
Typical B.S. softball questions from Kolbert of Maxim and Silva of B. Rilley.

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STAR Results Announced 24 Jul 2017 16:41 #9645

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No, I did not listen to today's call.
From what you have posted what is conspicuously missing is how they plan to survive.
We will hear how much cash is left...it
wont be much, besides they need to keep 5 million in reserve due to the loan.
Remember the s-3 filed May 12 and the $100 million amount !!!! Did anyone really buy the excuse from management on savings on filing fees ??? I didnt but thats my opinion. IMHO, there where serious issues unknown to us.
So back to this trial...on OA trial failure they used the excuse that it was always under powered, but I only remember that excuse post failure. Sounds like you are saying they are trying a different version today...LOL Oh my.
Well, these type of things had me at 60/40 odds. To me there were many things to question.
I may listed to the quarterly call in about 2 weeks or so....company spin can be amusing.
Only question is where does the cash to go forward come from ???? Dont expect a clear answer !!!!

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STAR Results Announced 24 Jul 2017 17:11 #9646

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Hedge, I could not believe that you have practically said good bye - I could not believe a smart man like you would be caught in this mess.

I asked Tiago Girao a month ago that the there was a huge short position out there, indicating a big STAR disaster is brewing- should I hold on to the shares? He said no comments - could not give advice-"you can understand". I asked him to be honest - his reply was "he is honest"- they did not have the 24 and 48 month data at the time. I figured out it was useless to communicate with him.

I wrote him today - Hedrick should step down ! (first time writing to him in over a month).

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STAR Results Announced 24 Jul 2017 17:13 #9647

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I think deSilva is more trustworthy than Jason K.

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STAR Results Announced 24 Jul 2017 17:37 #9648

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I believe Franshei that they had a good feeling on where this was going and could explain the ludicrous deal they pulled with Maxim on that last offering announced after hours. That now appears to be an act of desperation to get what they could before the news hit. I admire your enthusiasm and will probably ride this a little longer but I've been down this road before with a biotech and don't see how they can continue as Hedge has pointed out with their debt and no credibility for future financing.

Hedge, no mention of financing in today's call. All spin on the results.

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