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Re: None

Monday, 09/22/2014 2:51:03 PM

Monday, September 22, 2014 2:51:03 PM

Post# of 403481
"The data shows that by Day 7, the average cure rate for all four treatment arms was higher than what was observed in the phase 2a study, and similar to – if not higher than – cure rates reported for common ABSSSI drugs, as well as those approved this year."

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".


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