Athersys Fails Stroke Trial In Mid-Stage Study

Shares of Athersys (ATHX) are down sharply by about 50% today after the company announced results for its phase 2 trial using multistem cell therapy to treat patients with Ishemic stroke. The company announced that it had failed to meet both the primary and secondary endpoints of the study. The trial compared the company's Multistem cell therapy  to a placebo compound. The mulistem cell therapy failed to show a significance when compared to the placebo compound of the study at a 90 day time point. 

Athersys did state that there were some benefits for using Multistem over a placebo. One benefit observed was lower mortality rates and life threatening adverse events. Some benefits were even seen in lowering infections and pulmonary events. But these findings along with the safety data still doen't change the fact that Multistem trial failed to meet both the primary endpoints and secondary endpoints, which related to recovery from stroke. 

The trial enrolled approximately 126 patients who either took high doses of Multistem or placebo. The primary endpoint of the study looked for safety and global stroke recovery at day 90. Athersys' Multistem failed in this regard for global stroke recovery at day 90. In addition the secondary endpoints were looking for recovery and dysfunction including biomarkers associated with subject condition and recovery.  Multistem failed the secondary endpoint as well. 

For the time being the company does have other clinical programs, in acute-myocardial infraction -- AMI -- and acute respiratory distress syndrome -- ARDS. The AMI program has only completed a phase 1 trial and now needs to run a large phase 2 trial. With respect to the ARDS program it has only achieved non-clinical results and the company needs to initiate a phase 1 trial for patients in the clinic.

Before this trial failure Athersys, with partner Pfizer (PFE), ran a phase 2 trial in patients with Ulcerative Colitis using Multistem cell therapy compared to a placebo as well. This phase 2 trial also failed, because it failed to show a statistically significant reduction in severity of the disease along with lower rectal bleeding as compared to a placebo compound over an 8-week period. We think investors should avoid investing in this company as a long term play but probably could look at it in terms of a day trade. But still investors should be cautious trading this based off today's failed results. 

Disclosure: no position any stocks mentioned

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Frank Underwood 9 years ago Member's comment

Doesn't phase me at all. Only risking a few thousand dollars... about 1% of portfolio. more than willing to gamble

Dragan 9 years ago Member's comment

Super curious to see what is said on Monday. Needless to say, worst case scenario, I see 3.00 by end of next week.

Derek Snyder 9 years ago Member's comment

I have to admit this stock has either taken years off my life or added them.

Clark Winslow 9 years ago Member's comment

I admit, I talked my wife into buying this stock and she about had a stroke when she saw what it did on Friday.

Farah Kincaid 9 years ago Member's comment

I feel her and you. It blows. But from appearance, it really is just people who do not understand the data.

Dick Kaplan 9 years ago Member's comment

Finally, a logical take. Can't blame PFE for this

Craig Newman 9 years ago Member's comment

Logical? Sounds more like negativity to me.

Terry Chrisomalis 9 years ago Contributor's comment

It's all russian roulette now for Athersys. I guess you could claim I'm being negative I'm just stating facts. Company didn't meet on either endpoints.

The company now has to hope that the FDA will allow it to continue another trial in a subcategory which is a big "if". Even then the company now must await the fate of their partner Chugai who will decide if they even want to continue.

I'm just telling investors to be cautious because no longer are investors putting their money into the science. Now its in the hands of the FDA and Chugai. A rejection from both would be a huge blow for Athersys. It's possible it could go the other way but investors have to decide if its worth the risk?

Dan Jackson 9 years ago Member's comment

Short seller afraid of rebound?