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Cytori´s Technology- Celution, IP etc etc
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TOPIC: Finally- STAR trial starts enrollment

Finally- STAR trial starts enrollment 06 Aug 2015 07:04 #4935

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Apparently FDA approvals for design changes to Celution were the cause for the hold up..

SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) today announced the launch of its U.S. phase III/pivotal trial to study the efficacy of its ECCS-50 cellular therapeutic in patients with scleroderma associated hand dysfunction.

In July 2015, Cytori received follow-on U.S. FDA investigational device approval for recent updates to the Celution® System, which is being used in the STAR trial. The updates include recent technologic advances such as enhanced software code that substantially improves the efficiency of the bedside therapeutic manufacturing process for ECCS-50.

Currently three U.S. centers have been initiated. Cytori anticipates that the majority of investigational sites will be active by October 2015. Screening of patients has begun and it is expected that the first U.S. patients will be treated this month. A variety of promotional activities for the STAR trial will begin after Labor Day; however, the STAR microsite is currently active at: www.startrial-us.com/ . Enrollment duration is expected to be approximately 1 year.

“Hand involvement creates one of the most significant quality-of-life issues faced by people living with scleroderma, causing pain and significant disability,” commented Robert Riggs, Chief Executive Officer of the Scleroderma Foundation, Inc., the leading patient advocacy and research nonprofit organization for the scleroderma community. “It’s exciting to see a therapy advance through clinical trials that is intended to address this debilitating and disfiguring manifestation of scleroderma.” More information on the Scleroderma Foundation can be found at the following link: www.scleroderma.org/site/PageServer#.VcJOjUu3bfM

STAR is an eighty patient randomized, double blinded controlled trial of a single dose of the ECCS-50 therapeutic compared to placebo. Details of the trial including inclusion and exclusion criteria can be found at the following link: clinicaltrials.gov/ct2/show/NCT02396238?term=Cytori&rank=5

The STAR trial was predicated on promising data from the European phase II/pilot trial named SCLERADEC which was published in 2014 (Granel et al. Annals of Rheumatic Diseases) and reported data suggesting that the treatment was safe and potentially effective in improving certain hand symptoms in patients with scleroderma. The data can be found at the following link: ard.bmj.com/content/early/2014/08/10/annrheumdis-2014-205681.full .

Subsequent follow up of the SCLERADEC patients at 12 months revealed that the beneficial effect of Cytori’s ECCS-50 therapy in scleroderma was found to persist beyond 12 months and that data has been accepted for publication and is currently in press.

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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:

Finally- STAR trial starts enrollment 06 Aug 2015 08:28 #4936

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The only time Cytori has exceeded expectations was the early competition of the ACT-OA trial. The expectation has been set that it will take one year for 20 trial sites to treat a total of 80 patients. The actual injection of the cells into the fingers takes 10x longer than injecting them into a knee. (20 minutes instead of two minutes). :bash: :bash:

The good news is that this is a phase III trial. There are tens of biotech companies out there with billion dollar plus market caps based on Phase II and Phase III trials underway. Cytori sits under $70 million. A potential partner might say to Jeremy, "why don't I just buy the whole company."

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Finally- STAR trial starts enrollment 06 Aug 2015 08:57 #4937

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Hand function aside, they must convince 80 patients that this new treatment is worth pain relief for a year or less.
On the other sad side of the FDA coin is these 80 patients that do see the physical improvement in their hands cannot get a systemic treatment here in the USA once their disease advances.

Dare we hope that the 1 year projected time frame is just a case of under promise, over deliver ? They have gotten a lot of grief for poor timeline projection over the years and perhaps they are being conservative just in case. Forgive a brief moment of optimism, still a bit sleepy !

EDIT: Forgot to add they could have sold years ago, think of the potential valuation then !!! Now with debt and a battered PPS we would be in our usual disadvantaged negotiating position. That said I wonder how receptive the tired and feeble hands at Cytori would be ?

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Finally- STAR trial starts enrollment 06 Aug 2015 09:26 #4939

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DOV wrote: Cytori sits under $70 million. A potential partner might say to Jeremy, "why don't I just buy the whole company."


Yes DOV, the rumor should be worth a couple of dimes??

Anyway, the question is WHY aren't they buying a 70 million company that could be worth billions.... in this market bubble and nobody wants them? because except a couple of us hanging around here, nobody believes they are worth it. And you know it!


:vegas:

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Finally- STAR trial starts enrollment 06 Aug 2015 10:01 #4940

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SCLERADEC Trial - Twelve patients with SSc were enrolled from December 2012 through May 2013 in an open-label, single-arm and single study site.

At the same pace as the SCLERADEC Trial ( 2 patients treated per month per site), the STAR Trial should be completed in two months once all 20 sites are up and running. I don't understand the reasons why the enrollment rate would be so different.

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Finally- STAR trial starts enrollment 06 Aug 2015 10:15 #4941

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At the same pace as the SCLERADEC Trial ( 2 patients treated per month per site), the STAR Trial should be completed in two months once all 20 sites are up and running. I don't understand the reasons why the enrollment rate would be so different.


Agreed- does not make sense period. :evil:

What also does not make sense, is to put a link to one´s own website which is apparently wrong or does not exist... :bang: :bash:


Startrial-us.com leads to a Godaddy page (an hoster of doubtful reputation) : http://www.startrial-us.com

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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:
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