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Re: Viperciara post# 2838

Tuesday, 07/05/2016 12:34:20 PM

Tuesday, July 05, 2016 12:34:20 PM

Post# of 3108
More than interesting, Viper; very informative. The article is dated June 10th, and at that time they state that there are 19 subjects enrolled in the study. We know that the initial subset of 18 is a proof of concept cohort:

An initial safety analysis of the data and early analysis of immunological biomarkers will occur after the first cohort of 18 subjects has completed the three-month post-treatment visit. Pending review of the data from the first cohort and recommendation of the independent Data Safety Monitoring Board, a second cohort of 93 subjects will be enrolled. An interim efficacy analysis will occur after approximately 50% of all subjects reach the six-month follow-up milestone.

so that means that we should have the DSMB recco in by the end of September.

It also seems that Sanford is possibly going to continue enrolling for the second 93, although that's less clear.

Sanford has 19 kids enrolled in the study and hope to expand to over 100 in the coming months.



All up, more info than we've had out of the Company by far! Great find, many thanks. We now have a partial time-line. Also, IF Sanford continues to enroll and continues at the current rate of about 2/week, by the end of September we could have over a third of the second cohort of 93 enrolled. Clinical trials (https://clinicaltrials.gov/ct2/show/NCT02691247) shows two other sites in the Dakotas ready to start enrollment, which could really speed things up... but they are probably waiting for the early (3 month) 18 data. IDK.
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