There has been a lot of excitement this week about a press release from stem cell biotech Athersys that reported that treatment of stroke patients with its product MultiStem was associated with a statistically significant improvement at 1-year.
This sounds encouraging and the stock has spiked up as a result.
However, there are some naysayers including long-time stem cell biotech critic Adam Feuerstein, who today painted the Athersys press release as little more than spin.
Feuerstein went through a list of what he describes as negative clinical trial results for MultiStem, particularly at earlier time points after stroke. For instance, he asks essentially, “how could MultiStem fail to help paints earlier in the recovery phase and then suddenly help them at 1-year?” His answer is that it couldn’t and he compares the stem cell product as well as its reported positive results at 1-year to the Titanic in some biting analogies.
I feel like I need to dig more into the this before having a good sense of what the real deal is here. By the way I’m no fan of Adam’s and for some unknown reason he still has me blocked on Twitter.
What do you all think about this Athersys press release and the prospects for the company? If you disagree with Feuerstein, why is he wrong?
For those interested, here is a link to an EXTENSIVE research article I recently published on the science behind the Athersys stroke trial: http://seekingalpha.com/article/4005856-systems-go-athersys-pivotal-stem-cell-stroke-trial-japan-exploring-scientific-evidence .
The results are what they are there’s no spin about it, it was a double blind randomized placebo trial. People using Multistem are getting better and the p value suggests it’s not by chance. More importantly the biomarker data is indicating an effect that matches the original therapeutic hypothesis. From earlier 90 day results “The MultiStem treated group also had a significantly lower level of circulating CD-3+ T-cells at two days following dosing (p less than 0.001), suggesting a reduction in the inflammatory response post-stroke, consistent with the therapeutic hypothesis… Preliminary analysis of biomarker data obtained from samples of study subjects indicates that MultiStem treatment reduces post-stroke inflammation compared to placebo as evidenced by substantially reduced levels of multiple inflammatory cytokines, including IL-6, IL-12, TNFa and others. Furthermore, results suggest these effects are more pronounced for subjects receiving MultiStem administration within 36 hours. This effect is consistent with the hypothesized mechanisms of action and related preclinical data, and with the clinical data suggesting faster recovery for MultiStem-treated patients.”
@Brian, if you look you’ll find a wide range of papers that describe the mechanism of action and properties of MultiStem but you’ll have to search multipotent adult progenitor cells which is term for uncultured version of the cell. The cells are licensed to RTI Biologics in a commercially available bone allograft product.Here is a link that may guide you if you are interested in understanding the science: http://www.athersys.com/publications.cfm
WST
Reading the comments and their various links, I’m still very uncertain as to what exactly MultiStem is. I guess it’s too top secret to tell?
I gather that the mechanistic basis of the MultiStem treatment is to limit damage due to inflammatory response by modulating the spleen in some way? I’m not at all convinced that this is at all like the usual pathway to “healing a broken bone” — except for analogy in the sense of ameliorating compartment syndrome.
There is some evidence that culture-expanded autologous MSC/lysate therapies can help heal non-union fractures:
http://www.regenexx.com/wp-content/uploads/2008/07/non_union_fracture_research_paper.pdf
MultiStem is a totally different kettle of fish… I don’t see that the MultiStem “drug” has any prospect for healing a stroke victim in the same sense as the above “medical therapy” for non-union fractures.
AF is up to his usual bag of tricks to rag on a stock to drive it down for the shorts. Isn’t he a Cramer apostle and follower of the same admitted play book. I look for ATHX to struggle to hold a good pps until another deal for US trials is inked. The therapy may not end up being the best that will be, but it will do until the best gets here.
Being blocked by AF on Twitter should be a badge of courage and a source of pride, LOL. Sort of like having The Devil tell you he doesn’t want you in Hell.
Hi Paul,
Adam derisively dismissed the 365 day data that was presented this week at an International Stroke conference sponsored by the AHA. The 365 day data were secondary endpoints in the trial that showed statistically significant efficacy. The performance above the placebo group improves further when the treatment window is reduced from 48 to 36 hours. Adam also fails to respond to a simple question: Why would Healios, a Japanese regmed biotech, pay Athersys $15,000,000 for the rights for stroke development in Japan and agree to cover all development costs? I met with and spoke to the CEO of Healios, Hardy T S Kagimoto, M.D., in NYC a couple of weeks ago and I can tell you he was very excited about the upside of the stroke therapy and was thrilled that Chugai walked away. With regard to the 90 day post-hoc analysis, I covered it extensively in this article: http://seekingalpha.com/article/3769446-top-stock-idea-2016-athersys-beaten-stem-cell-stock-great-upside?v=1455889399&commenter=1 and I encourage you to read it if you really want an in depth look at the 90 day data. I think we’d all like to hear what your your opinion on this. Will we get it?
Best
WST
@WST,
There aren’t enough hours in the day…hoping to get to it soon.
Isn’t the athersys data just confirming what regenerative medicine is all about? Over the long term there was further regeneration and therefore greater efficacy? As far as the street article, it looks like a piece written to get a rise vs express logical thought. The titanic is a static event whereas biology is living and evolving with thousands of biochemical processes starting and stopping over time based on biological events. The titanic comparison was simply a non starter.
The big take away for me is that it looks like multi stem is enabling healing processes to occur in stroke patients over time. it would be fun to write a counter argument to AF compare the results to any healing process …a broken bone, sprained ankle, a cut, etc… Vs the titanic.
Unlike Feuerstein, I can tentatively accept the possibility of a delayed improvement. What happens on the cellular level might not immediately manifest at the behavioural/motor/cognitive level.
My problems with the press release are two-fold:
(1) It’s too skimpy on what exactly the treatment is and the mechanism by which it is supposed to work is not sufficiently explained.
(2) The measurements are, fundamentally, of two distributions. The statistics reported seem to be of the wrong kind, given the nature of the measurements.
I guess that my point (2) aligns with the Titanic metaphor… It also reminds me of the investigation of the the Challenger disaster and Feynman’s explanation as to why the engineers and administrators had such totally different assessments of the risk that low temperature imposed to the O-ring seals:
http://science.ksc.nasa.gov/shuttle/missions/51-l/docs/rogers-commission/Appendix-F.txt
Whatever misguided conclusions he makes, you always get some very qualified people commenting and I learn far more from these than from his articles. In this case great insight from Kathrin Kortschak and WST.
There is NO UPSIDE to interacting with AF.
He purposefully writes things that are egregious to get hits/views/clicks. He’s the Skip Bayless of Biotech.
If you respond and tell him he’s wrong. He wins.
If you tweet him back and argue – he wins.
If you interact with him at all – he wins.
There is NO upside to addressing him or his articles. Even if you are 100% right and have ALL the data on your side – it will not make him say, ” You are right after all! ATHX is great!”
Having said that, I feel that the recently released data are a huge step forward in stroke treatment and am encouraged by the SIGNIFICANT excitement that the stroke neurologists at the AHA International Stroke Conference this week are showing. The buzz around the data is the talk so far.
Multistem is a paradigm shift in the standard of care for stroke treatment.