Athersys Inc (ATHXQ)

[KMBJN]

Trying to parse some numbers from the trial, per the PR:

MultiStem group, N=65 Placebo, N=61

Got both TPA+MR N=10?? N=9

Not both TPA+MR N=55?? N=52

MS <36 H N=27
(and No TPA+MR)

MS >36 H N=28??

DEATH N=4/65 (6.2%) N=9/61 (14.8%)

Excellent N=10/65 (15.4%) N=4/61 (6.6%) p=0.10
Outcome

POST HOC ANALYSIS: NO TPA+MR, MS<36H

N=27 N=52

Excellent N=5/27 (18.5%) N=1/52 (1.9%) p=0.03
Outcome


Above has excluded some folks with excellent outcomes, who also got TPA and MR: N=3-5?/10? N=3/9

(30-50% who got both TPA and MR did excellent, regardless of treatment, and it is this confounding that the post-hoc analysis tried to remove - in addition to the time window effect)

If add them back in, still have significant improvement with MultiStem when given <36 hours after stroke:

Excellent N=~8/32 (25%) N=4/61 (6.6%)
Outcome

If these results hold in a larger trial, in which MS is consistently given earlier (24-36H), then this would be a home run. I'm not even sure they need to wait 24H like they do now. I guess they tried to remove the confounding of stroke patients who spontaneously recover or worsen. Maybe they should open treatment from 12-36H, since earlier treatment clearly was better.


Can you imagine improving the outcomes to excellent for 4x as many people that suffer moderate to severe strokes (NIHSS from 8-20, mean 13 in this study)? Instead of only 5-10% recovering to "normal", you could have 25% being normal, a huge improvement for these folks.