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TOPIC: Scleroderma Update

Scleroderma Update 27 Apr 2016 07:03 #6867

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The press release barrage continues:

SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc(CYTX). today announced that its U.S. FDA approved Phase 3 STAR trial has enrolled and treated its 60th patient (75% of target enrollment). In addition, as per the trial protocol, an independent data monitoring committee has reviewed safety data from the initial 40 patients and recommended that the study continue as planned. The 60 procedures, including the fat harvest from small volume liposuction and the finger injections have all been completed successfully without complications.

“The pace of enrollment has exceeded our original planning and is an indication of the openness and hope from physicians and their patients in the potential for cell therapy as a viable option for scleroderma. Based on screening and scheduling of patients, completion of enrollment will occur by mid-June. We remain exceedingly grateful to the investigators, research staff and especially the patients who have participated,” said Dr. Steven Kesten, Chief Medical Officer, Cytori Therapeutics(CYTX).

STAR is a randomized, placebo-controlled, double-blind, parallel group phase III FDA approved pivotal study investigating the efficacy and safety of Cytori Cell Therapy (ECCS-50) injected subcutaneously into the fingers of patients with impaired hand function from scleroderma. A total of 80 patients will be randomized with 40 receiving Cytori Cell Therapy and 40 receiving placebo. The double-blind period extends to 48 weeks. After all patients have completed 48 weeks follow-up, the placebo patients will be offered active treatment 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

The STAR trial follows the twelve patient SCLERADEC-I pilot trial in which one year post-treatment results were published in the August 2015 edition of the journal Rheumatology. The two year results have recently been presented at the Systemic Sclerosis World Congress in Lisbon, Portugal. The data indicated that a single administration of ECCS-50 was safe and that treated patients exhibited significant improvements in hand symptoms, function and Raynaud’s Phenomena through two years following treatment.

Cytori announced in January 2016 that it entered into an agreement with Idis to establish a Managed Access Program (MAP) for its cellular therapeutic in select countries across Europe, the Middle East, and Africa for patients with impaired hand function due to scleroderma. Managed Access Programs provide biopharmaceutical companies with a way to allow ethical access to their pre-license/unlicensed medicines to help patients with unmet medical needs. Access is provided in response to physician requests in a fully compliant manner, where no alternative treatment options are available. The source of medicine funding varies and may include the hospital’s budget or country’s sickness fund or social security system.
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Scleroderma Update 27 Apr 2016 07:27 #6868

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Wall Street Titan wrote: The press release barrage continues:


"Barrage?"- I found just 2 press releases (plus 1 investor note) in the past month rather modest... :whistle: I hope this is start of a real "barrage" and we see the PPS much higher on May10th. :cool: It seems that the market likes the game and has been kind of expecting this... :yawn:

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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:

Scleroderma Update 27 Apr 2016 10:45 #6872

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There was also the story on alopecia trial although it was not a press release. Ok Maybe not a barrage.

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Scleroderma Update 27 Apr 2016 10:54 #6873

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18 of 19 sites now recruiting

Enrollment seems on schedule but looks like we wont be finishing ahead of schedule like the OA trial. I was hoping scleroderma demand would get us enrolled a bit faster but site roll out was a bit slower than I anticipated.

Next up, burn and cardiac data.

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Scleroderma Update 27 Apr 2016 12:18 #6874

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myownhedgefund wrote: Next up, burn and cardiac data.


Yep- these are the sure things- another one is the Q1 financials, which normally should be around the 8-10th of May i.e. could even "almost" coincide with the shareholders meeting on the 10th.

A scientific paper on a PI investigation is always possible- the Danish ED clinic was rather impressive, I found. Thereto the Japanese PAD clinic which could be very very important while a lot of patients (relatively- i.e. 40) and I have not forgotten Bernhard Lampert and Calhoun especially with ATHENA coming... :whistle: and if a partner deal is not in the works- Calhoun´s chances rise IMHO. :bye:

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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:

Scleroderma Update 27 Apr 2016 15:34 #6878

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More company photos on Cytori Twitter: 2016 Rheum Conference Stand 36: the lady could be cytxer's girl friend.

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Scleroderma Update 27 Apr 2016 16:35 #6879

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*** and if a partner deal is not in the works- Calhoun´s chances rise IMHO.***

Ca-CA-CALHOUN !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

Warming up just in case...LOL :evil: :puke: :evil: :puke: :cry: :bash:

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