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Re: ImmunoATX post# 120435

Sunday, 08/30/2015 1:08:53 PM

Sunday, August 30, 2015 1:08:53 PM

Post# of 402734
Outstanding, super well-informed post. You explained the design and challenges of the Phase 2 B-OM trial very clearly. Thank you.

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:

Dear Dr xxx
thanks so much for your email.
we are very excited that subjects are now enrolled in the OM study at two different sites and more sites are being activated in the next several weeks.
Our press release was mean to inform investors and the public of the beginning of subject enrollment and we plan to provide periodic updates in the future.
Actual subject enrollment at each site is dependent on a number of factors - including hospital location and size of the population. We have carefully chosen sites that should be able to enroll qualified subjects in the most rapid manner possible.

Best regards, Jim Alexander



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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