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Scleradec II enrolled 22 Jan 2018 08:03 #10979

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Finally some news....:bye:

Jan 22, 2018
SAN DIEGO, Jan. 22, 2018 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc. (NASDAQ:CYTX) announces completion of patient enrollment in SCLERADEC II (NCT02558543), a randomized, double-blind, placebo-controlled, parallel group, multi-center clinical trial intended to study the safety and efficacy of Habeo™ Cell Therapy in up to 40 subjects with impaired hand function due to scleroderma (systemic sclerosis).

In this investigator-initiated clinical trial supported by Cytori, a total of 40 patients were enrolled among 5 French centers: Marseille, Montpelier, Rouen, Lyon, and Paris. The primary endpoint is improvement over baseline in the Cochin Hand Function Scale at 3 months. Full analysis of the unblinded data set, including results for secondary endpoints such as pain, quality of life, mobility, strength, tactile sensitivity, Raynaud’s Phenomenon, and vascular suppression, will be performed upon completion of the final patient’s 6 month follow-up visit. Data will be available in the second half of 2018 and may support potential future regulatory submissions in Europe and selected regions.

“Cytori would like to thank the investigators and patients participating in the SCLERADEC II trial.” Said Dr. Marc Hedrick, Cytori’s President and Chief Executive Officer. “We believe that the combination of the findings from SCLERADEC II, the results from Cytori’s U.S. STAR clinical trial, and anticipated feedback from our FDA pre-submission meeting later this quarter will provide us with a clearer picture of the optimal path forward with this therapy in the U.S., Europe and other important markets.”

In SCLERADEC II, all patients had Habeo Cell Therapy prepared from their adipose tissue. Patients randomized to the treatment arm had cells administered to their fingers via injections on the same day while patients randomized to receive placebo, had their cells cryopreserved for future use. The open-label crossover arm in the trial allows patients randomized to placebo to receive their cryopreserved cells after 6 month data have been analyzed and reviewed by an independent monitoring committee. Eligible patients electing to receive treatment with cryopreserved cells will be followed for both safety and efficacy for 6 months.

About SCLERADEC II Investigators

The SCLERADEC II trial is being led in Marseilles, France by Prof. Brigitte Granel of the Department of Internal Medicine of the Assistance Publique Hôpitaux de Marseille (APHM) with support from Prof. Florence Sabatier of the Cell Therapy Department and Prof. Dominique Casanova from the Department of Plastic Surgery, Conception Hospital, APHM. The other French centers include: Prof. I. Auquit (Plastic Surgery), Dr. Ygal Benhamou (Internal Medicine), and Dr. O Boyer (Cell and Gene Therapy Unit) of the University Hospital Center of Rouen (CHU Rouen); Prof. D. Farge (Internal Medicine), Prof. M. Chaouat (Plastic Surgery) and Prof. J Larghero (Cell and Gene Therapy Unit) of Saint Louis Hospital of Paris; Prof. A Hot (Internal Medicine) of Edouard Herriot Hospital of Lyons and Prof. C Jorgensen of University Hospital Center of Montpellier.

About Scleroderma

Scleroderma is a rare, debilitating, and sometimes fatal, chronic autoimmune disease. 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. Systemic Sclerosis (SSc) is the most serious form of scleroderma with an estimated 125,000 active cases in the U.S. and 2.5 million globally. 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 SSc.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:

Scleradec II enrolled 22 Jan 2018 08:35 #10980

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Re previous post by Fas - interesting comment by Hedrick - "and anticipated feedback from our FDA pre-submission meeting later this quarter" - originally, this had been expected by some posters earlier than "later this quarter" - that's okay imo.

PS - Interesting that Cytori now appears to be posting directly onto its Yahoo website with news items.

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Scleradec II enrolled 22 Jan 2018 10:20 #10981

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Looks like this data will have a hard time beating a Reverse split deadline even if they get their extension.
Too bad enrollment was slow.
We already knew the Houston project was running behind.

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Scleradec II enrolled 22 Jan 2018 10:47 #10982

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rodney.strongg wrote: PS - Interesting that Cytori now appears to be posting directly onto its Yahoo website with news items.


Cytori uses a news distributing agency- without knowing what outlets were targeted in the past- they probably changed theirs again (like underwear) to one that has Yahoo on their distribution list.

Hedge- I presume you mean the production tests in San Antonio?

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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:

Scleradec II enrolled 22 Jan 2018 10:50 #10983

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LOL...yeah...that's it Fas :bash:

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Scleradec II enrolled 22 Jan 2018 10:58 #10984

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fas wrote:

rodney.strongg wrote: PS - Interesting that Cytori now appears to be posting directly onto its Yahoo website with news items.


Cytori uses a news distributing agency- without knowing what outlets were targeted in the past- they probably changed theirs again (like underwear) to one that has Yahoo on their distribution list.


May be, but questionable - you should invite them to post on your site - LOL.

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Scleradec II enrolled 23 Jan 2018 10:37 #10985

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Rodney
Please do not misunderstand what I am writing below.
Since December, I have come to the realization that Hedge maybe right in the 2018 scenario (my Scenario no. 2). This PR and the delay in releasing the results of the FDA meeting confirm that a second phase 3 sleroderma trial is coming. While a EU ATI 0918 partnership is not coming because a pending US FDA approval for an ANDA is not coming (a good distributor is the next best choice), CYTX needs more cash to restart the corporate engine in the second half of 2018. It is now very likely that we are all facing a R/S (unavoidable in my current opinion). I do not think a corporate buyout is coming soon - thee is no strategic value unless there is some kind of regulatory approval to validate that the celution system really works (therapeutic value, beyond plastic surgical arena). The current cell therapy business is very small to attract a buyer presently, while AIT 0918 ANDA project is falling behind by at least one quarter and the revenue flow will not come till mid 2019.
R/S is probably coming to activate the Lincoln Park ATM machine (as "John" mentioned during the Q/A during the 3rd Q CC).
This stock has been manipulated up and down and we should be all careful in my opinion.

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Scleradec II enrolled 23 Jan 2018 10:56 #10986

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franshei wrote: Rodney
Please do not misunderstand what I am writing below.
Since December, I have come to the realization that Hedge maybe right in the 2018 scenario (my Scenario no. 2). This PR and the delay in releasing the results of the FDA meeting confirm that a second phase 3 sleroderma trial is coming. While a EU ATI 0918 partnership is not coming because a pending US FDA approval for an ANDA is not coming (a good distributor is the next best choice), CYTX needs more cash to restart the corporate engine in the second half of 2018. It is now very likely that we are all facing a R/S (unavoidable in my current opinion). I do not think a corporate buyout is coming soon - thee is no strategic value unless there is some kind of regulatory approval to validate that the celution system really works (therapeutic value, beyond plastic surgical arena). The current cell therapy business is very small to attract a buyer presently, while AIT 0918 ANDA project is falling behind by at least one quarter and the revenue flow will not come till mid 2019.
R/S is probably coming to activate the Lincoln Park ATM machine (as "John" mentioned during the Q/A during the 3rd Q CC).
This stock has been manipulated up and down and we should be all careful in my opinion.


Welcome to the huge bunch of naysayers - interesting that you should now agree with HF who I believe has really been confounded over CYTX's stock action during the last few weeks and has not posted hardly at all - GLTY.

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Scleradec II enrolled 23 Jan 2018 12:20 #10987

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rodney.strongg wrote: Welcome to the huge bunch of naysayers - interesting that you should now agree with HF who I believe has really been confounded over CYTX's stock action during the last few weeks and has not posted hardly at all - GLTY.


A little discord in the formerly happy family? :grin:

Rodney- things are not black and white.... there are many shades of grey as is well-known. I agree with Franshei, that the FDA meeting must have been held late November and the latest mid December. Delay in the decision letter sounds positive to me, since that indicates that they have a nut to crack.

I think the market sees that that way too. For that reason there is some upwards momentum.

With all stuff that may come from ISS trials and the list of events below, there seems to be plenty of gunpowder. Thereto I interpret the holdings of the Swiss online bank totally different as all other Raccoons...we will see who is right...:whistle:


Again- the upcoming stuff-
Attachments:

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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:

Scleradec II enrolled 23 Jan 2018 13:41 #10988

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Fas, it appears that it is just the two of us left with any optimism - regarding your last post, can you clarify your interpretation of the Swissquote Bank holding because you indicate that you are the only raccoon with that interpretation (I thought that you and I were on the same page in that regard?)

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Scleradec II enrolled 24 Jan 2018 07:39 #10994

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rodney.strongg wrote: Fas, it appears that it is just the two of us left with any optimism - regarding your last post, can you clarify your interpretation of the Swissquote Bank holding because you indicate that you are the only raccoon with that interpretation (I thought that you and I were on the same page in that regard?)


Rodney- I do not remember you stating an opinion on Swissquote. I just remember Hedge and WST saying they are "European Sabby´s" if you like.
I do not think that is correct. They are not an investment fund and if you search at Nasdaq, they simply are no institutional investor in ANYTHING, besides apparently Cytori.
They are a brokerage firm for wealthy folks and are only allowed to attract customers where those folks are concentrated- i.e. Switzerland, the Middle East and some financial centres.

This means to me they are accumulating for a customer and will sell in due course to those folks they have contractual obligations with at a certain price.

Whatever that means.There are several options.:whistle:

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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:

Scleradec II enrolled 24 Jan 2018 07:45 #10995

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fas wrote:

rodney.strongg wrote: Fas, it appears that it is just the two of us left with any optimism - regarding your last post, can you clarify your interpretation of the Swissquote Bank holding because you indicate that you are the only raccoon with that interpretation (I thought that you and I were on the same page in that regard?)


Rodney- I do not remember you stating an opinion on Swissquote. I just remember Hedge and WST saying they are "European Sabby´s" if you like.
I do not think that is correct. They are not an investment fund and if you search at Nasdaq, they simply are no institutional investor in ANYTHING, besides apparently Cytori.
They are a brokerage firm for wealthy folks and are only allowed to attract customers where those folks are concentrated- i.e. Switzerland, the Middle East and some financial centres.

This means to me they are accumulating for a customer and will sell in due course to those folks they have contractual obligations with at a certain price.

Whatever that means.There are several options.:whistle:


Fas. I agree - also, I believe that the "customer" could possibly have a partnership or takeover aspiration.

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Scleradec II enrolled 24 Jan 2018 12:23 #10996

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rodney.strongg wrote:
Fas. I agree - also, I believe that the "customer" could possibly have a partnership or takeover aspiration.


Of course- I would be very naive and short-sighted to think of anything else. Accumulating such big stakes for a traditionally "no volume" ticker symbol just for speculation at this PPS level - considering the reputation of management and BOD- and the eternal money issues, would be extreme silly.

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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:

Scleradec II enrolled 24 Jan 2018 16:37 #10997

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Fas, why isn't my latest post under the caption of "Good Two Days" that I made within the last two hours showing up as a current post of today - it's posted, but not showing as today.

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Scleradec II enrolled 24 Jan 2018 18:32 #10998

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Rodney

Another two good days in the making! As John has indicated on Yahoo MB, after 47 cents, we might have another leg to go up (challenging 55 cents).

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Scleradec II enrolled 24 Jan 2018 19:41 #10999

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B7 and Rodney
We are too concerned with the fundamentals and even R/S.
Right now CYTX has become a great trading stock - technical is the king.

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Scleradec II enrolled 25 Jan 2018 01:47 #11000

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franshei
I would suggest a slight correction.
Momentum is king and the momo players are shooting against the technicals.

I posted last week I believe on the YMB, they are serving a function. (imho) ....... best just to let it play out unless one wants to play along..

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