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TOPIC: Tigenix meets primary endpoint in P3 clinic

Tigenix meets primary endpoint in P3 clinic 24 Aug 2015 08:05 #5018

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At least Tigenix has some news that is excellent and shows the efficacy of cell therapy. Too bad, its an unknown Belgian Company, but I think they will do well in the applications Cytori should have started ages ago. Cytori did not, so -for that reason I also became a Tigenix stock holder... :nice:

......# A single injection of Cx601 was statistically superior to placebo in achieving combined remission at week 24 of complex perianal fistulas in Crohn's disease patients with inadequate response to previous therapies, including anti-TNFs
........# More than 50% of patients treated with Cx601 achieved combined remission at week 24
............#A higher number of Cx601-treated patients had their fistulas closed by week 6

The results confirm the favourable safety and tolerability profile of Cx601 These positive data allow for European filing in the first quarter of 2016 and moving forward in the US with the SPA[1]-approved pivotal study

LEUVEN, Belgium, Aug. 23, 2015 (GLOBE NEWSWIRE) -- TiGenix NV (Euronext Brussels: TIG), an advanced biopharmaceutical company focused on developing and commercialising novel therapeutics from its proprietary platforms of allogeneic expanded stem cells, announced today that its lead compound Cx601 met the primary endpoint in the Phase III ADMIRE-CD trial in Crohn's disease patients with complex perianal fistulas. Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC) injected intra-lesionally. A single injection of Cx601 was statistically superior to placebo in achieving combined remission at week 24, in patients with inadequate response to previous therapies, including anti-TNFs. The study results confirm the favourable safety and tolerability profile of Cx601.
ADMIRE-CD is a randomised, double-blind, placebo-controlled Phase III study designed to confirm the efficacy and safety of a single injection of Cx601 in the treatment of complex perianal fistulas in Crohn's disease patients. In total, 289 patients were recruited across 50 active sites in 7 European countries and Israel. Patients included had an inadequate response to previous therapies, including anti-TNFs. Continuation of medical standard of care was allowed during the duration of the trial in both groups. The study primary endpoint was combined remission at week 24, defined as closure of all treated external openings draining at baseline despite gentle finger compression, and absence of collections >2cm confirmed by MRI.

In the ITT population (n=212), Cx601 achieved statistically significant superiority (p<0.025) with 49.5% combined remission at week 24 compared to 34.3% in the placebo arm. In the mITT[4] population (n=204), the combined remission rates at week 24 were 51.5% and 35.6% for Cx601 and placebo, respectively (p<0.025). These results translate into an observed relative risk of 1.44, meaning that patients receiving Cx601 had 44% more chances to achieve combined remission than placebo patients. Efficacy results were robust and consistent across all statistical populations.
Treatment-emergent adverse events (non-serious and serious) and discontinuations due to adverse events were comparable between Cx601 and placebo arms.
"We are extremely excited about the results of Cx601 in this severely debilitating and difficult to treat condition. Achieving more than 50% combined remission in patients who have not responded adequately to previous treatments, including anti-TNFs, is a remarkable accomplishment", said Dr Marie Paule Richard, Chief Medical Officer of TiGenix. "We are committed to submit these data to the EMA and to bring this innovative new treatment to patients whose life is impacted by the challenges of this serious condition".
Full efficacy and safety results will be presented at the 11th Congress of ECCO (European Crohn's and Colitis Organisation).
"The results of this large robust controlled study are clinically relevant and open a completely new avenue for the treatment of perianal fistulising Crohn's disease, one of the most severe manifestation of this process. The therapy affords a 44% increased chance for patients of closing their fistula with a single injection, which is a major breakthrough", said Dr Julian Panes, Head of the Gastroenterology Department, Head of the Inflammatory Bowel Diseases Unit, and Associate Professor of Medicine at the Hospital Clinic of Barcelona, President-Elect of ECCO, and Chairman of TiGenix ADMIRE-CD Scientific Advisory Board.
"This is a landmark achievement for TiGenix", said Eduardo Bravo, CEO of TiGenix. "These positive results, together with the recent endorsement by the FDA of our Phase III trial design for the US, let us move full steam ahead making Cx601 available to the more than 100.000 patients who every year suffer from this serious condition".
Webcast and conference call
On Monday 24 August, at 15:00h CET/9:00h EDT, TiGenix will conduct a conference call and webcast. The following speakers will present the Top-Line results of the trial, explain the next steps for Cx601 and the Company, and will take questions:
Mr Eduardo Bravo, Chief Executive Officer of TiGenix
Dr Marie Paule Richard, Chief Medical Officer of TiGenix
Dr Julian Panes, Head Gastroenterology Department, Head IBD Unit, and Associate Professor of Medicine at Hospital Clinic of Barcelona, President-Elect of ECCO, and Chairman of TiGenix ADMIRE-CD Scientific Advisory Board

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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:

Tigenix meets primary endpoint in P3 clinic 24 Aug 2015 11:58 #5020

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sounds interesting, will be watching it for the post-crash fishing trip.

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Tigenix meets primary endpoint in P3 clinic 24 Aug 2015 13:50 #5021

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for that r

eason I also became a Tigenix stock holder... :nice:


Surprised that you own Tigenix given the allogeneic model.

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Tigenix meets primary endpoint in P3 clinic 24 Aug 2015 14:55 #5022

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Wall Street Titan wrote: for that r

eason I also became a Tigenix stock holder... :nice:


Surprised that you own Tigenix given the allogeneic model.


That's what Chuck would say :bye:

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Tigenix meets primary endpoint in P3 clinic 24 Aug 2015 14:59 #5023

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Surprised that you own Tigenix given the allogeneic model.


Yes- me too :grin: From the PPS near ATL-time to buy? thread..

Could not resist buying a couple of Tigenix also- since my comfort level with allo cultured ASC is higher than with the marrow stuff- plus- it apparently works, for which reason they just arranged an SPA with the FDA on their phase III for fistula....yes- my favorite application..

Spanish Cellerix who merged with Tigenix several years back and who`s management (Bravo CEO) is running the Company now, has experience with fistula since 2004 or so. Various auto cultured ADSC studies, but they did not have much joy with that- the Phase II was stopped with the explanation that "clinical reality lead to this decision".

They tried again with allo and it works- I do not know why, but their brew does not seem to be straight forward culturing of plastic adherent (stem) cells and they know the value of the Tregs (non-stem cells) in adipose, which hardly is found in marrow.

Lets say- its kind of a safety investment, if cytori management screws up the REAL- and most promising technology.

Mind you Tigenix management I think is pretty decent- they might find a partner soon- probably Novartis or Roche would fit well. :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:

Tigenix meets primary endpoint in P3 clinic 25 Aug 2015 00:34 #5026

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SAN DIEGO, CA -- (MARKETWIRE) -- 08/09/12 -- Cytori Therapeutics (NASDAQ: CYTX) has expanded the Celution® System CE Mark in Europe to include several new indications, including cryptoglandular fistula. Cryptoglandular fistula is the most common cause of perianal infection, abnormal fecal contamination and incontinence. In a related development, an investigator-sponsored clinical study in Japan using the Celution® System for treatment of cryptoglandular fistulae was approved under the new Ministry of Health, Labor and Welfare (MHLW) Guidelines on Clinical Research Using Human Stem Cells and enrollment is underway. The Celution® System provides clinical researchers with easy access to adipose-derived stem and regenerative cells (ADRCs) at the point-of-care.

The positive results for TiGenix are also beneficial for CYTX. Obviously they have first mover advantage in the USA and Europe with trials that will give them access to reimbursement but we should not underestimate the value of the CE Mark (see above) . It validates the device and its output in the treatment of Cryptoglandular fistula. TiGenix has a strong potential competitor in Cytori.

It would be great to know the relative benefit of the allo product vs the autologous product generated by Celution. I would imagine that with the excellent safety profile in a multitude of indications it should be feasible for CYTX to go straight into a phase III trial. If this is possible it would be interesting to know if they would have to face the allo product as the SOC or whether they could use the same SOC used in the TiGenix trial? In either case it would very easy to determine the better treatment.

Does anyone have any idea of the cost for creating the expanded ADRC in the Tigenix process?. The cost benefit relationship will be key in determining the winner, ie. cost of treatment vs inconvenience of lipo (all subject to efficacy).

We don't hear anything out of Japan re the fistula trials ................... The silence is deafening ................. :bash:

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Tigenix meets primary endpoint in P3 clinic 25 Aug 2015 06:31 #5027

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***We don't hear anything out of Japan re the fistula trials ***

There's no plan for Japan....LOL

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Tigenix meets primary endpoint in P3 clinic 25 Aug 2015 15:07 #5031

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Any input about their financial health?

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