Monday, September 22, 2014 2:51:03 PM
In trying to quantify "higher than what was observed in the phase 2a study" I received 4 similar responses:
"As I recall the original Phase 2a study performed at over 90% on all arms of that study."
"The Phase 2b trials were showing efficacy generally above 90% and the PR said Phase 2a results were "higher"."
(note: I THINK that was transposed in error.)
"The p2a had an overall effectiveness of well over 90%, and the p2b was better than that at 7 days, according to Leo."
"The results were better than those seen in the Phase 2a, which averaged above 90% cure rate."
The quote at the top and the PR in which it appeared related to the study of Brilacidin's treatment of Acute Bacterial Skin and Skin Structure Infections (“ABSSSI”). I could be wrong, but I believe that the "over 90%" performance/effectiveness/cure rates cited above mistakenly refer to Brilacidin's use in treating oral mucositis:
"Brilacidin-OM, a defensin mimetic compound has shown in the laboratory to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo.
http://cellceutix.com/cellceutix-submits-application-for-irb-review-to-commence-phase-2b-clinical-trial-of-novel-antibiotic-brilacidin/
"In animal models of oral mucositis, an oral rinse containing Brilacidin was shown to reduce the occurrence of severe ulcerative oral mucositis by more than 90% compared to placebo."
http://www.sec.gov/Archives/edgar/data/1355250/000147793214005027/ctix_10k.htm
I have been unable to find any confirmation that the Phase 2a study, which I believe was conducted while the drug was still in the hands of Polymedix, showed effectiveness rates in treatment of Acute Bacterial Skin and Skin Structure Infections (“ABSSSI”) over 90% or any other percentage.
Either I missed it...always possible....or the feedback that I received related to the treatment of the wrong condition. If I missed it, I'm hoping that one of the four who responded can point me to it. In the absence of any confirming documentation of a source of "over 90%" or any other number in the treatment of ABSSSI, this phrase will remain unquantified as far as I can tell:
"higher than what was observed in the phase 2a study".
cc:
thefamilyman
frrol
noretreat
BigKahuna
"I ated the purple berries"
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