Sunday, August 30, 2015 1:08:53 PM
On August 3 I sent a note to Dr. Alexander:
Dr. Alexander,
I very much appreciate what you and the Cellceutix team are doing to advance the pipeline. i am a long term investor with approximately xxxk shares.
A couple of Brilacidin oral rinse questions:
(1) It looks like enrollment opened at the first two sites about 9 weeks ago. Do you know about how many patients have been enrolled from these first two sites and if any have completed the 7 week treatment regimen?
(2) Reviewing the inclusion and exclusion criteria for the B-OM trial, can you give me an idea of about how many patients are likely eligible at each center over a 'typical' month? I am trying to get a read on how easy/difficult it is to find patients for what appears relatively stringent trial criteria.
Thank you very much.
And the appropriate somewhat vague response:
So all I really know is that as of the 1st week of August, more than a couple patients were enrolled. It's interesting that we both used the term 'stringent' to describe trial inclusion criteria and you outlined the reasoning really well. I think this particular population has 90%+ incidence of severe (Grade 3,4) oral mucositis but my sources are somewhat conflicting.
I hope they can enroll one patient every week at each site but this might be overly optimistic. No basis for my opinion but I was thinking/hoping 1 or 2 a month at each location (your 2nd scenario). Perhaps Leo will give us a better read in the coming weeks.
Thanks again. Looking forward to your ongoing thoughts/comments.
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