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TOPIC: New STAR data presented

New STAR data presented 15 Feb 2018 07:19 #11312

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Feb 15, 2018
SAN DIEGO, Feb. 15, 2018 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (Nasdaq:CYTX) (“Cytori” or “the Company”) today presented data from the U.S. 88 patient, 19 center, randomized, double blind, placebo-controlled STAR clinical trial of Cytori Cell Therapy™ (Habeo™) for the treatment of impaired hand function in patients with systemic sclerosis (SSc). These data were presented on behalf of the study investigators by Principal Investigator, Dr. Dinesh Khanna of the University of Michigan, at the 5th Systemic Sclerosis World Congress in Bordeaux, France.

This presentation included data not previously reported by the Company including responder analyses based on Minimal Clinical Important Differences (MCID) for the Cochin Hand Function Scale (CHFS) and for the Health Assessment Questionnaire-Disability Index (HAQ-DI) which are validated instruments assessing hand function and overall disability respectively in patients with SSc. Data from exploratory end points and details on the safety profile of Habeo were also presented.

The newly reported findings show consistency of efficacy across end points such that, 48 weeks after treatment, 52% of subjects with diffuse SSc treated with Habeo showed improvement that exceeded the MCID for both hand function (CHFS) and disability (HAQ-DI) compared with only 16% in the placebo arm. This difference in response rate was associated with a nominal p-value = 0.016.

Furthermore, the data showed that 47% of subjects with diffuse SSc who were treated with Habeo reported at least moderate improvement in disability (HAQ-DI) at 48 weeks compared with only 16% in the placebo arm (nominal p-value = 0.035). Consistent with the CHFS data, these differences were more evident in disability (HAQ-DI) domains related to hand function (e.g. eating and grip) than they were in domains less relevant to the hand (walking and arising).

“Impaired hand function is a serious problem for patients with scleroderma for which there is no currently-approved treatment,” said Dr. Dinesh Khanna, Principal Investigator of the U.S. STAR clinical trial. “The finding that patients already receiving current standard of care, showed further sustained meaningful improvement in hand function in response to Habeo represents an important new potential approach in our ability to help patients counter the debilitating effects of this disease.”

Other newly-reported data from the STAR trial include:

Health-related Quality of Life assessed using the standard EQ-5D instrument in patients with diffuse SSc showed worsening in the placebo arm and improvement in the Habeo-treated arm (nominal p-value = 0.011).
Patient assessment of SSc activity at 48 weeks in patients with diffuse SSc also improved in the Habeo-treated subjects and worsened in subjects in the placebo arm (nominal p-value = 0.015).
º Physician assessment of SSc activity showed a similar trend though with a p-value = 0.17.
The procedure and treatment was well-tolerated and had a strong safety profile:
º 2.1% (1/48) of all subjects in the Habeo-treated arm and 12.5% (5/40) of those in the placebo arm reported serious adverse events (SAEs). No SAEs in the hand or deaths were reported.
º The overall rate of adverse events was very similar for both groups: 82.5% in the Habeo group and 81.3% in the placebo group.
º Peripheral vascular events (e.g., hypertension, hypotension, digital infarction, and worsening of Raynaud’s phenomenon) were observed in 15% (6/40) of placebo treated subjects compared with none (0/48) in the Habeo-treated group.
º Calcinosis was observed in 12.5% (5/40) of subjects in the placebo group compared with 2.1% (1/48) in the Habeo group.
“Our complete analysis of data from the STAR trial is very encouraging. The safety profile exhibited by Habeo is clear and the efficacy signals and trends are consistent,” said Dr. Marc H. Hedrick, President and Chief Executive Officer of Cytori Therapeutics. “Based on this data set, we have provided a detailed report to FDA in preparation for a pre-submission meeting scheduled for later this quarter with the goal of defining next clinical and regulatory steps in the U.S.”

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.

About Scleroderma
Scleroderma is a rare and chronic connective tissue disease generally classified as an autoimmune rheumatic disorder. The word “scleroderma” is derived from two Greek words: “sclera,” which means hard, and “derma,” meaning skin, as hardening of the skin is one of the most visible manifestations of the disease. An estimated 300,000 Americans have scleroderma, about one-third of whom have the systemic form of the disease, known as systemic sclerosis (SSc). SSc is further sub-classified as diffuse cutaneous and limited cutaneous SSc. Patients with diffuse cutaneous SSc have more severe disease with significant hand dysfunction and internal organ involvement. Diffuse scleroderma accounts for between one-third and one-half of all cases of systemic sclerosis.1,2

SSc contributes to hand impairment through inflammatory arthritis or inflammation of the joints, joint contractures, Raynaud’s Phenomenon (RP, skin discoloration resulting from narrowing of the blood vessels in response to cold, emotional upset, or stress), digital ulcers, puffy hands and skin fibrosis over the fingers and hands, and calcinosis (calcium deposits in the soft tissues of the hand). These manifestations, which often coexist, can contribute to difficulty with occupational activities and activities of daily living, which can impair quality of life. Whereas current treatment recommendations focus on management of internal organ involvement, there is little treatment available for hand impairment.

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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:

New STAR data presented 15 Feb 2018 07:21 #11313

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Actually that all reads quite well.

Franshei-

“Based on this data set, we have provided a detailed report to FDA in preparation for a pre-submission meeting scheduled for later this quarter with the goal of defining next clinical and regulatory steps in the U.S.”


What does this mean?

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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:

New STAR data presented 15 Feb 2018 10:13 #11315

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I suppose that means they have not had their meeting "after the holidays" (assuming that was Thanksgiving)- yet. Or is there possibly a multi-meeting process that we are not aware of?

Anyway- I am pleased with what I read and with due pressure on the FDA by the interest groups - i.e. the Scleroderma society, anything seems to be possible with diffuse scleroderma.

Opinions?

Crazy market action in my view

PS Rodney- I took the liberty in deleting your post, since it had the same content as the above. :yep:

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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:

New STAR data presented 15 Feb 2018 10:34 #11316

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fas wrote: I suppose that means they have not had their meeting "after the holidays" (assuming that was Thanksgiving)- yet. Or is there possibly a multi-meeting process that we are not aware of?

Anyway- I am pleased with what I read and with due pressure on the FDA by the interest groups - i.e. the Scleroderma society, anything seems to be possible with diffuse scleroderma.

Opinions?

Crazy market action in my view

PS Rodney- I took the liberty in deleting your post, since it had the same content as the above. :yep:


No problem - I only had the highlights - appears as if CYTX got their move late yesterday - the sell-off today on decent volume is giving most of it back - looking to join you in buying some more at these prices.

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New STAR data presented 15 Feb 2018 15:08 #11317

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fas wrote: I suppose that means they have not had their meeting "after the holidays" (assuming that was Thanksgiving)- yet. Or is there possibly a multi-meeting process that we are not aware of?

Anyway- I am pleased with what I read and with due pressure on the FDA by the interest groups - i.e. the Scleroderma society, anything seems to be possible with diffuse scleroderma.

Opinions?

Crazy market action in my view

PS Rodney- I took the liberty in deleting your post, since it had the same content as the above. :yep:


Franshei, your input would be much appreciated - I hope you are well - have not heard from you lately.

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New STAR data presented 15 Feb 2018 18:51 #11319

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Fas et al, given that Takeda has spent a large amount of money to buy Tigenix for their allogeneic adipose stem cell plaform does it not seem at least slightly plausible that there is value in an autologous option for treating fistula from Crohn's. Surely if the allogeneic works then the autologous could pose a serious challenge to Tigenix/Takeda in this and any oher possible indicaions.

Surely Takeda could buy CYTX to secure its position and cover both the autologous and allogeneic options. They would also hit the ground running with a large number of trials already in place in Japan.

Just wondering ........... why managemen isn't looking at making a real deal. Now we have two Swiss dropboxes for shares holding over 20%.
No poison pill? Just wondering.

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New STAR data presented 15 Feb 2018 19:30 #11320

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Fas
I had originally took the FDA meeting was going to be in the new year as when they said after the holidays it was pleural but they also said by year end.
The usual confusing output from Cytori.
I assume they sent a data packet to the FDA ahead of time to support what Cytori wants to do and the meeting in Q1 2018 will be to discuss that point.
My two cents anyway.

I felt the data was mixed to be honest.
www.cytori.com/wp-content/uploads/2018/02/Khanna-STAR-Results-SSWC.pdf

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New STAR data presented 15 Feb 2018 19:37 #11322

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rongside wrote: Fas et al, given that Takeda has spent a large amount of money to buy Tigenix for their allogeneic adipose stem cell plaform does it not seem at least slightly plausible that there is value in an autologous option for treating fistula from Crohn's. Surely if the allogeneic works then the autologous could pose a serious challenge to Tigenix/Takeda in this and any oher possible indicaions.

Surely Takeda could buy CYTX to secure its position and cover both the autologous and allogeneic options. They would also hit the ground running with a large number of trials already in place in Japan.

Just wondering ........... why managemen isn't looking at making a real deal. Now we have two Swiss dropboxes for shares holding over 20%.
No poison pill? Just wondering.


Rongside, very interesting post. The mystery continues.

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New STAR data presented 16 Feb 2018 09:32 #11323

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First- the mystery surrounding the FDA meeting- I reviewed the Q3 transcript from November last year again and this is what it said on STAR approvability i.e. next steps-

So next steps with respect to this, as I touched on briefly before, is that we anticipate pre-submission meeting with the FDA soon. Likely, it will be after the holidays. The goal there is to determine the PMA device approvability or conditional approvability, perhaps, with restrictive claims. If the approvability is not an option, then we intended to obtain clarification on the exact next steps for approvability ultimately in the U.S.

In addition, we are nearing full enrollment in the SCLERADEC-II trial in France with a planned enrollment of up to 40 patients as I mentioned. The trial design in that trial in France substantially mirros STAR except that principally that the efficacy determination is to be evaluated at 12 weeks as opposed to 24 and 48 weeks that we looked at these end points in STAR. Of note, in the STAR trial, after 12 weeks, the primary endpoint, which is Cochin Hand Function Score and secondary endpoint is namely hack the eye and Raynaud's condition score were statistically significant in a combined group at 12 weeks. Improvement at 12 weeks in SCLERADEC-II married with STAR data maybe sufficient to support expanded approval in Europe beyond our existing capacity use approval. SCLERADEC-II results are anticipated in 2018.

Likewise, with additional data in diffuse patients from SCLERADEC-II, this could support the STAR trial findings for our U.S. and Japanese regulatory efforts for HABEO. Our most recent PMDA feedback suggest that like the ADRESU, stress urinary incontinence trial, an open label trial without placebo may be acceptable for approval as an orphan device.


It seems like after the holidays is simply - in 2018. So no meeting is held yet and even SCLERADEC II might play a role in the discussions.Given the new additional data, I do see a chance for a "happy ending", so remain optimistic.

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New STAR data presented 16 Feb 2018 10:18 #11324

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rongside wrote: Fas et al, given that Takeda has spent a large amount of money to buy Tigenix for their allogeneic adipose stem cell plaform does it not seem at least slightly plausible that there is value in an autologous option for treating fistula from Crohn's. Surely if the allogeneic works then the autologous could pose a serious challenge to Tigenix/Takeda in this and any oher possible indicaions.

Surely Takeda could buy CYTX to secure its position and cover both the autologous and allogeneic options. They would also hit the ground running with a large number of trials already in place in Japan.

Just wondering ........... why managemen isn't looking at making a real deal. Now we have two Swiss dropboxes for shares holding over 20%.
No poison pill? Just wondering.


John,
I guess the problem is, that there simply are no published data on fistula with ADRC´s, besides the Borowski paper on 6 patients from 2012. The 2010 added claim in the UK obviously was backed by data (otherwise you do not get a claim) but was never published by either Cytori or Olympus.
No one knows , except we. You are right - the 600 Mio+ that Takeda will pay for Tigenix is somewhat out-of-line with the Cytori market cap of 20-25 Mio.

On the Swiss dropboxes- I do think they are moving under the 10% ownership level and I do not think these big sales are sold on the market, but over the counter somehow.

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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:

New STAR data presented 16 Feb 2018 10:32 #11325

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Hi Fas
So I still see little chance for stand alone STAR data getting past the FDA
Now if we are to include SCLERODAC 2 data...that likely wont be available until late June. So while this treatment seemed to peak at 12 weeks with STAR and that is when the new French trial will be looking...it will be some time past the stated Q1 FDA meeting. If we consider current cash and time for the FDA to include this for consideration...it certainly seems tight from a time perspective.

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New STAR data presented 16 Feb 2018 10:54 #11326

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fas wrote:

rongside wrote: Fas et al, given that Takeda has spent a large amount of money to buy Tigenix for their allogeneic adipose stem cell plaform does it not seem at least slightly plausible that there is value in an autologous option for treating fistula from Crohn's. Surely if the allogeneic works then the autologous could pose a serious challenge to Tigenix/Takeda in this and any oher possible indicaions.

Surely Takeda could buy CYTX to secure its position and cover both the autologous and allogeneic options. They would also hit the ground running with a large number of trials already in place in Japan.

Just wondering ........... why managemen isn't looking at making a real deal. Now we have two Swiss dropboxes for shares holding over 20%.
No poison pill? Just wondering.


John,
I guess the problem is, that there simply are no published data on fistula with ADRC´s, besides the Borowski paper on 6 patients from 2012. The 2010 added claim in the UK obviously was backed by data (otherwise you do not get a claim) but was never published by either Cytori or Olympus.
No one knows , except we. You are right - the 600 Mio+ that Takeda will pay for Tigenix is somewhat out-of-line with the Cytori market cap of 20-25 Mio.

On the Swiss dropboxes- I do think they are moving under the 10% ownership level and I do not think these big sales are sold on the market, but over the counter somehow.


With respect to the last paragraph, is it possible that the sales are going gradually to the "intended buyers" from the Swiss front-men (particularly since the Swiss do not seem to making much (if any) money from the RO price)?

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New STAR data presented 19 Feb 2018 03:37 #11341

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[color=]rongside wrote: Fas et al, given that Takeda has spent a large amount of money to buy Tigenix for their allogeneic adipose stem cell plaform does it not seem at least slightly plausible that there is value in an autologous option for treating fistula from Crohn's. Surely if the allogeneic works then the autologous could pose a serious challenge to Tigenix/Takeda in this and any oher possible indicaions.

Surely Takeda could buy CYTX to secure its position and cover both the autologous and allogeneic options. They would also hit the ground running with a large number of trials already in place in Japan.

Just wondering ........... why managemen isn't looking at making a real deal. Now we have two Swiss dropboxes for shares holding over 20%.
No poison pill? Just wondering.

John,
I guess the problem is, that there simply are no published data on fistula with ADRC´s, besides the Borowski paper on 6 patients from 2012. The 2010 added claim in the UK obviously was backed by data (otherwise you do not get a claim) but was never published by either Cytori or Olympus.
No one knows , except we. You are right - the 600 Mio+ that Takeda will pay for Tigenix is somewhat out-of-line with the Cytori market cap of 20-25 Mio.

On the Swiss dropboxes- I do think they are moving under the 10% ownership level and I do not think these big sales are sold on the market, but over the counter somehow.

[/color]



Fas, actually there is additional data on fistula , although admittedly not enough to prove statistical significance. They are :

www.ncbi.nlm.nih.gov/pubmed/26342817

onlinelibrary.wiley.com/doi/10.1111/codi.13555/abstract

Also lets not forget that we have the French Fistula in Ano trial data hopefully being published soon.

clinicaltrials.gov/ct2/show/NCT02520843?term=fistula+adipose&cntry1=EU%3AFR&rank=1

While individually non of these trials is conclusive proof of efficacy, collectively they provide VERY substantial proof of efficacy. Given that the Japanese data was compelling I cannot imagine that there would be a high hurdle for entry into that market.

I tend to believe that CYTX is already sold. The powers that be are simply waiting for the FDA meeting outcome to determine price. The value is there........ the question is what % of our original investment will be offered. ? :KO: :evil:

Does anyone have an opinion regarding this indication. ? Relative efficacy vis a vis marginal cost differential is what should be of interest. Surely some doctor/researcher in Japan will be itching to do a comparison trial one day?. To all the device manufacturers out there beware, the croupier is ready to say
''rien ne vas plus''

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