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TOPIC: Tigenix reports 6 M AMI results of AlloCSC01

Tigenix reports 6 M AMI results of AlloCSC01 25 Jun 2016 09:07 #7311

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While we have been seeing quite a few cardiac SC clinic results reported off late, we might as well take this one too. This is an ACUTE clinic i.e. comparable to APOLLO of Cytori and most of the early MI clinics in Europe with whole marrow and some in the US. By the way- Tigenix acquired a small SC Company dealing with HEART donor derived cells which than obviously have to be cultured.


The announcement from 06-17-2016:

TiGenix Announces Six-Month Phase I/II Results Of AlloCSC-01 In Acute Myocardial Infarction

Leuven, Belgium (GLOBE NEWSWIRE) - TiGenix NV (Euronext Brussels:TIG), an advanced biopharmaceutical company focused on the development and commercialization of novel therapeutics from its proprietary platforms of allogeneic expanded stem cells, today announced preliminary six-month results from the CAREMI clinical trial, an exploratory Phase I/II study of AlloCSC-01, TiGenix's expanded cardiac stem cell treatment for acute myocardial infarction.

CAREMI is the "first-in-human" clinical trial to evaluate the safety and efficacy over twelve months intracoronary infusion of AlloCSC-01, a suspension of allogeneic human expanded cardiac stemcells (CSCs), in patients with acute myocardial infarction (AMI) and left ventricular dysfunction. Enrollment was completed in November 2015 with 49 patients randomized (AlloCSC-01: placebo; 2:1). The preliminary interim data is comprised of the six-month follow up of the 49 randomized patients plus two patients from the escalation phase who received similar target doses of 35 million cells (51 in total). Eight centers are participating in the CAREMI trial led by Prof. Fernández-Avilés, Head of the Department of Cardiology at the Hospital General Universitario Gregorio Marañón in Madrid (Spain), and Prof. Janssens, Head of the Department of Cardiovascular Diseases, University Hospital, Leuven (Belgium), as principal investigators.

"We are happy to report the preliminary interim results from our exploratory study of AlloCSC-01 in AMI that broadens our clinical development pipeline in a large area of unmet need", said Dr. Marie Paule Richard, Chief Medical Officer at TiGenix. "The safety results confirm that intracoronary delivery of AlloCSC-01 is well tolerated during the acute and sub-acute phases of the infarct, fulfilling the principal goal of the study at six months."

As per the protocol design, the primary objective of this study is to provide evidence of the acute and long-term safety profile of AlloCSC-01. On the primary acute safety endpoint, no mortality of any cause within one month was recorded for both placebo and AlloCSC-01 groups. Similarly, no major adverse cardiac event (MACE) was recorded within one month in either group. Importantly for the long term safety evaluation, no MACE was recorded in either two group at six months. Preliminary secondary efficacy data at six months was limited to infarct size evolution, defined as a percent of the left ventricular mass measured by magnetic resonance imaging. The mean absolute change in infarct size from baseline to six months was similar in both groups. The final full set of safety and efficacy study results at twelve months will be reported in first half of 2017.

"The positive data reported today shows the safety of early intracoronary delivery of AlloCSC-01 post-AMI" said Prof. Fernández-Avilés. "We are encouraged by the safety outcome and are optimistic that this first-in-human trial with a novel cell population will be an important milestone in our quest to find a better treatment for patients at high risk of cardiac remodeling and heart failure."

"A key question of the CAREMI study was the safety of a relatively early administration of allogeneic cardiac stem cells. This has now been addressed. We now look forward to the final safety and efficacy analysis" concluded Prof. Janssens.

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Tigenix reports 6 M AMI results of AlloCSC01 25 Jun 2016 09:27 #7312

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Preliminary secondary efficacy data at six months was limited to infarct size evolution, defined as a percent of the left ventricular mass measured by magnetic resonance imaging. The mean absolute change in infarct size from baseline to six months was similar in both groups.


When I read the announcement, it was interesting to learn that the same old gang is still doing MI clinics in Europe. Paco or Prof. Fernandez-Aviles was Co-PI in PRECISE and Prof. Janssens did a BMSC MI clinic which had my EXTREME interest, since it used auto BM cells within 24 hours after MI- similar as Cytori, which provided cells also within 24 hours after the event.

So- the clinic - with 49 patients- was safe but had no efficacy results. With other words will be ditched after 18 months (similar) results will be reported. Just below a slide which indicated the simple auto BM cells DID reduce infarct size and as I know, many of the patients treated are still living (which in the cardiac field is well-known but patients are not "allowed" to know.... :whistle:

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Tigenix reports 6 M AMI results of AlloCSC01 25 Jun 2016 09:42 #7313

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Since Chris Calhoun, Eric Duckers and Emerson Perin are surely still lurking in the background. :whistle: It is my absolute conviction that ADRCs delivered within 24 hours of MI (or stroke) are presently by far the most efficient therapeutic available to stop the spiraling process to heart failure in cardiac patients.

Hedrick knows that (for which reason he hid ADVANCE data) and insiders of the technology know that. I know that BIG BUCKS are involved here- BP wants to treat CHF patients- not having them live normal lives of course, so this will not be easy. But I am convinced, it will come one day., in my lifetime and it will have that disruptive character that BP does not like of course... :yep:

Janssens BM cells were good- ADRCs are better:










and APOLLO was the only clinic I have ever seen, where arrhythmia issues were statistically significant with an total n=14 :whistle: :cool:
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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 reports 6 M AMI results of AlloCSC01 25 Jun 2016 11:21 #7314

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Allogeneic stem cells in AMI are safe and not much else. This data along with the lackluster results from the Mesoblast trial are confirmation that allogeneic has been a huge waste of time and capital. We complain about CYTX wasting capital. Perhaps it is better to say that they have not optimally allocated it rather than wasted it. After all, all the Celution trial data to date in the CHF and AMI indications has been stellar. :joy: :nice:

Heart disease is a sleeper, as we have not been able to fund it . We have also as a company tried to downplay its potential. Data was withheld and not given the publicity it deserved (ADVANCE trial) :KO:

However, the moment that the ADRC are approved for an indication like scleroderma the financials for the company will do a 180. Also the perception of ADRC in a host of indications will be significantly enhanced. At that point in time the heart indications will be marketable at a price that better reflects the potential of ADRC and Celution. :grin:

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Tigenix reports 6 M AMI results of AlloCSC01 25 Jun 2016 23:17 #7316

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Calhoun lurking ?
Thats all he has ever done.
Oh, OK liberated others of their money as well. :whistle:
As again recently mentioned, it was going to be sports medicine, the ut oh the was going go after cardiac.
All he really is doing is lurking on someone else's dime.
Until proven otherwise I still see wide spread cardiac treatment using Cytori's process looks like it wont happen until their patents are expired....maybe we get lucky and see a small taste before they are expired. Whats left 12 years ?

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Tigenix reports 6 M AMI results of AlloCSC01 26 Jun 2016 09:28 #7317

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myownhedgefund wrote: Calhoun lurking ?
Thats all he has ever done.
Oh, OK liberated others of their money as well. :whistle:
As again recently mentioned, it was going to be sports medicine, the ut oh the was going go after cardiac.
All he really is doing is lurking on someone else's dime.
Until proven otherwise I still see wide spread cardiac treatment using Cytori's process looks like it wont happen until their patents are expired....maybe we get lucky and see a small taste before they are expired. Whats left 12 years ?


Just checked Hedge- as per LinkedIn- he is still lurking on Celactive´s dime, so he does not cost us- we only have to pay the heavy Hedrick salary & cash bonuses. I have no clue on those patents- even do not want to guess, but think that is irrelevant at present. My preference is that further development of the cardiac apps is picked up as soon as possible. On the one side I think CYTX investors deserve the highest rate of returns on their Cytori agony, but we should not forget patients. CCT, to me, would be the only cardiac therapy I would go for when I would need it (which I do not- but would not mind an anti-aging shot, one of these days :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:

Tigenix reports 6 M AMI results of AlloCSC01 27 Jun 2016 03:23 #7318

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Last night I watched Fat Chance: Fructose 2 on YouTube for the third time- Dr. Robert Lustig is damn right and brilliant and I think I get the biochemical cycles now. I am already living by its conclusions, but did not understand the leptin/insulin connection perfectly well- now I do, I think.

Anyway- again highly recommended the video´s from Lustig on sugar being a poison.

The connection I wanted to show here in this thread is the slide below- it makes perfect sense that Calhoun probably found his financiers in the Middle East and where I do suspect some ultimate holdings of Cytori shares, which I hope was not a plan which was brilliantly executed by Mr. Rickey and Hedrick.... :whistle:



Diabetes is most prevalent on this globe in the rich Arab States, which means at the same time metabolic syndrome and a lot of cardiac problems.

Why do you think that is? Well- first it is hot down there and the water supplies are of doubtful quality. Alcohol is forbidden, which would be self-limiting due to its impact on the brain, but soda pops are not. Although the sugar in the soda works as alcohol on the system, they drink virtually unlimited supplies of the poison and get the metabolic syndrome. :whistle:

Surely it will take another 50 years to eliminate the western Coke habits in those states, so a medical solution is badly needed... :bye: :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:
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