Athersys Inc (ATHXQ)

[H2R]

Masters-2 ~ 2020

we recently initiated the MASTERS-2 study, our registration study of MultiStem therapy for treatment of ischemic stroke. Shortly after open patient recruitment, we enrolled our first several patients in this study. This study initiation represents an important milestone for our lead MultiStem program and for the company as it represents our first Phase 3 study.

We plan to employ a phased ramp up of this study, initiating with a small number of sites in the U.S. this year, adding a larger number of U.S. sites early next year, followed by European sites. This approach reflects a number of factors, including our ongoing support of Healios' TREASURE study, management of the operational requirements associated with initiating large number of sites and regulatory considerations in Europe.

Overall, as we have summarized previously, the study will include 300 subjects and will be conducted at approximately 50 clinical sites in North America and Europe. It is difficult at this point to project with precision when we expect to complete this study, but our target is to complete enrollment sometime in 2020. Though we are just at the beginning of the trial, the early enrollment activity and the investigator enthusiasm for the study is very promising.

https://seekingalpha.com/article/4196150-athersys-inc-athx-q2-2018-results-earnings-call-transcript?part=single


From https://clinicaltrials.gov/ct2/show/record/NCT03545607 :

 
 Estimated Study Start Date  ICMJE	July 2018 
 Estimated Primary Completion Date	December 2020   (Final data collection date for primary outcome measure)

I also like the fact that the Current Primary Outcome Measures is "assessment of disability by examining the distribution of modified Rankin Scale (mRS) scores [scale range = 0 to 6] evaluated by shift analysis [ Time Frame: 90 days ]"

In other words, the completion of the enrollment should point nicely to the completion of the trial. Some trials are less clear. I hope they give an update on this enrollment every quarterly CC. That would help firm up the completion date and remove some surprises.