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TOPIC: Athersys first UC results out

Athersys first UC results out 28 Apr 2014 08:40 #1607

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This is disappointing for both ATHX as well as the industry :cry:

7:09 am Athersys announces results from Phase 2 study of multistem cell therapy for ulcerative colitis; multistem demonstrates good tolerability and safety profile but fails to show efficacy over 8 weeks in patients with chronic, advanced ulcerative colitis (ATHX) :

Co announced interim results from the Phase 2 clinical study of the administration of Athersys' MultiStem cell therapy to treatment refractory ulcerative colitis patients being conducted by Pfizer, Inc. The study results demonstrate favorable safety and tolerability for MultiStem through 8 weeks following treatment. However, the cell therapy failed to show meaningful benefit, following a single administration, in patients suffering from chronic, moderate-to-severe UC who have failed other therapies.
These results reflect patient data 8 weeks following cell therapy or placebo administration and include the primary efficacy endpoints for the study. Additional 16-week results, including data about the impact from a second round of dosing for a subset of patients, longer term secondary clinical endpoints, and biomarker evaluation will be available after additional analysis has been completed.
Data highlights from the 8-week interim analysis include:
MultiStem cell therapy demonstrated favorable tolerability and safety profile through 8 weeks following treatment; In this chronic, advanced UC patient population, a single IV administration of MultiStem did not show a statistically significant improvement compared to placebo in the primary efficacy endpoints -- change in endoscopic score from baseline as measured by modified Baron score at 8 weeks and change in Mayo rectal bleeding subscore from baseline at 4 and 8 weeks; and At 4 weeks, the proportion of responders on MultiStem was significantly greater than placebo but the benefit was offset by declines in a minority of MultiStem-treated patients such that overall benefit at all time points measured was not significant. Multiple additional secondary endpoints at week 4 and week 8 were also explored and there were no significant differences observed between the two groups including clinical remission and clinical response.

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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:

Athersys first UC results out 28 Apr 2014 09:12 #1608

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No use to analyze anything- others will do that for us surely.

The Clinical trials record is : HERE

Amazing- they were finished right as planned - APRIL 2014. That is different elsewhere.... :whistle:

By the way- THERE MUST BE SOME DATA OUT THERE FOR TREATMENT OF IBD WITH ADRCS!!!!!!

Remember: Cellsociety presentation in 2013: Treating Inflammatory Bowel Disease with Adipose Derived
Regenerative Cells Hiroshi Yoshimoto, MD, PhD

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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:

Athersys first UC results out 29 Apr 2014 07:22 #1618

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Fas, it is true that the news is bad for Athersys and many others in the industry ............ but not necessarily for usl. :winky:

Allogeneic BM derived stem cells which have undergone massive cell expansion is now a questionable treatment for UC. The data is not positive and I doubt Pfizer will continue.

An additional bit of bad news for the BM brigade is the following meta-analysis regarding autologous trials in heart disease. While utilizing autologous stem cells which is similar to the CYTX approach, we all know that BM is a very poor source for regenerative cells compared to ADRC. It is also important to remember that many BM trials use expanded cells due to the very small number of cells available, and lets not forget that BM stem cells are less vigorous vis a vis ADRC. All this may well be responsible for the less than stellar results.

www.forbes.com/sites/larryhusten/2014/04/28/stem-cell-therapy-to-fix-the-heart-a-house-of-cards-about-to-fall/

Somehow all this bad news is I believe positive for CYTX. Our potential competitors are being proven to be not as effective as they have presented themselves. Provided that ADRC perform as we expect, the investment community will eventually be forced to recognize the unique potential of Celution and ADRC.

Fas, I recall that you were rather skeptical concerning Mesoblast's approach. Could it be that allogeneic and cell expansion is not enough....... or....... not optimal. Any comments?

Like you I am anxious to know how that IBD trial is going. Given our Crohn's fistula success (?) it would not be unreasonable to expect good things. Perhaps Hiroshi will one day choose to let us know.
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Athersys first UC results out 29 Apr 2014 12:41 #1625

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John-

Foremost- let me state that the scientific paper, which is at the source of this Forbes article , to me smells like a an old fashioned "witch hunt" although it maybe sound science- I dont know- it smells like a pit hole article to me.

But yes - you are right of course. If you believe Caplan- this trend is bound to continue especially if you also believe what many (including Hedrick, Centeno and many others) have stated- culture a given cell beyond 4 passages, it loses some of its potency. If you do it thousands of times, well... I guess you know what comes.

I think we can agree that Prochymal failed- the 100 Mio Osiris will get for that is a small part of what they spent on R&D.
Remains Revascor and Multistem. Whatever marketing twist you want to give it- those brews are mixes of pericytes of some form i.e. precursors, which are not anything special.
Their lack of potency and the fact that certain potent cell types which appear in a heterogeneous BM or AD derived population, which however are not plastic adherent i.e. cannot be cultured in a cell line, makes the technology suspicious to me.

I think I warned on this board before- to go soft on ATHX- I am not proud of the fact that I was right (for a change) but will repeat that warning anytime for the above reasons plus a few more, which I did not state.
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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:

Athersys first UC results out 29 Apr 2014 13:37 #1626

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***Somehow all this bad news is I believe positive for CYTX. Our potential competitors are being proven to be not as effective as they have presented themselves. Provided that ADRC perform as we expect, the investment community will eventually be forced to recognize the unique potential of Celution and ADRC.***

Without disclosures of our trials and investigator studies the investment community doesnt care and is not willing to go just on faith...especially with our managements track record.

Touted 3 year PRECISE data a embarassment...nothing new.
Very small in size studies no one cares about right now
Most of the 50 touted investigator led studies regardless of size we know little ot nothing about
With no info...no way to assume a potential valuation...unless you are JK and believe in 2020 dreams

So while I agree watching the competition drop trials due to failure of their approach...CYTX has NOT distinguished itself as any different in a manner acceptable to large investors to date that makes a difference in the PPS !

The other selling point for Cytori of using ones own cells should also be a bonus besides the better efficacy.

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Athersys first UC results out 12 May 2014 03:50 #1666

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Probably the main reason why cryo-preserved off-the-shelf stuff like Multistem and Prochymal etc does not very well (or at all) in auto-immune disorders-

As Jacques Galipeau reported in conferences and in the paper, cryopreservation could negatively affect therapeutic “immunomodulatory value” of mesenchymal stromal cells (MSC). There was no independent confirmation of Galipeau’s findings, and many MSC product developers remained skeptical. This week, Katarina Le Blanc published a report, which supports Galipeau’s conclusions and provides more insight into potential clinical value of this phenomenon. Let me just say – this paper could change the field!


Alexey Bersenev´s article summarizes: link- Stemcell Assays
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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:

Athersys first UC results out 12 May 2014 18:37 #1674

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Fas, great find. If true, a total game changer. Cytori's real time fresh ADRC will destroy the ''off the shelf" frozen product.

Ideal for Crohn's and Scleroderma.

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