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TOPIC: SCLERADEC II enrolled first patient

SCLERADEC II enrolled first patient 19 Oct 2015 08:14 #5310

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10/19/2015
SAN DIEGO--(BUSINESS WIRE)-- Cytori Therapeutics, Inc. (NASDAQ: CYTX) announced that the first patient has been enrolled and treated in the SCLERADEC-II trial, a late phase, follow-on European clinical trial designed to determine the efficacy and safety of Cytori Cell Therapy™ in patients with hand dysfunction associated with scleroderma.

SCLERADEC-II is a multicenter, double blind, placebo controlled trial of a single administration of Cytori Cell Therapy (ECCS-50). The trial will enroll up to 40 patients randomized in a 1:1 fashion to either active or placebo control. The primary endpoint is the Cochin Hand Function Score at 3 months following treatment. Key secondary endpoints include Raynaud’s Condition Score, SHAQ, Pain, modified Rodnan Skin Score, capillaroscopy and functional hand assessment. Placebo patients will be eligible for cross over to the active arm after 6 months with their respective cryopreserved cells. If the trial endpoint is successfully achieved, this trial may be used to seek European marketing approval of Cytori Cell Therapy for this indication, which has been designated by the European Commission as an orphan medicinal product for treatment of scleroderma.

This trial is a follow on trial to the twelve patient SCLERADEC-I pilot trial which was published in the August 2015 edition of the journal Rheumatology. One year follow up of patients treated in this open label trial suggested that a single administration of ECCS-50 was safe and that treated patients exhibited significant improvements in hand symptoms and function.

“The sustained safety and benefit across a number of concordant endpoints in patients that received cell therapy in the SCLERADEC-I trial after 12 months of follow-up was very encouraging. This suggests the possibility that Cytori Cell Therapy may be a useful therapeutic option for patients who suffer from scleroderma,” said Dr. Brigitte Granel, North Hospital, Assistance Publique Hôpitaux de Marseille and the Principal Investigator on both the SCLERADEC I and SCLERADEC II trials, conducted by Marseille University Hospital. “We are hopeful that SCLERADEC II will substantiate these findings and help support product approval in Europe.”

The trial is sponsored by the Assistance Publique Hôpitaux de Marseille, Marseille, FR and conducted under an approval from the French national regulatory agency, Agence Nationale de Sécurité du Médicament et des produits de santé (ANSM), and supported by Cytori.

The SCLERADEC II trial is enrolling a similar population of patients as the U.S. pivotal STAR trial sponsored by Cytori. The STAR trial is an eighty patient randomized, double blind placebo controlled trial of a single dose of the ECCS-50 therapeutic compared to placebo. Details of the STAR trial including inclusion and exclusion criteria can be found at the following link: clinicaltrials.gov/ct2/show/NCT02396238?term=Cytori&rank=5

Full details of the SCLERADEC-II trial can be found on clinicaltrials.gov (NCT02558543).

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SCLERADEC II enrolled first patient 19 Oct 2015 08:32 #5311

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Looks like 6 of 18 sites in the US are now enrolling.

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SCLERADEC II enrolled first patient 19 Oct 2015 09:27 #5312

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Looks like 6 of 18 sites in the US are now enrolling.


Yes. As Franshei already has indicated----

this 6 recruiting locations is status as of September 21 . We were already pleased with the fact that the record was updated TWICE in 2015... normally that is very very rare... :grin:

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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 first patient 19 Oct 2015 11:04 #5313

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Credit to franshei then, I knew someone posted a number recently but couldn't remember if it was 4 or 6

Real news will be number treated to date and patient interest. Hopefully we get a hint in the November call.

Other news may be some ATHENA results discussion :yawn: :evil:

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SCLERADEC II enrolled first patient 19 Oct 2015 12:09 #5314

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Yes

Although ATHENA is NOT a core program any longer, I am very much curious and interested in meaningful data- that is, a different treatment as we got from the ADVANCE data, which was a joke.

Reason obviously- promising data, still could point to a potential partner deal sometime with somebody- government or device company. :whistle:

Anyway- the presentation data that Franshei referred to a while ago, on the investors page of the Cytori HP is pretty good- 42 slides with detailed information. I hear some folks were even treated to a long version (68 slides) , so the brass at Cytori DOES make a difference between big and small investors, but not as blatantly as in Calhoun days... :winky: :grin:

Here is the milestone stuff... so some BARDA info still to come this year... :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:
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