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F1ash

02/23/15 9:40 AM

#92289 RE: To infinity and beyond! #92287

Here is why you are not finding anything on SAE's. The reason they occured in the first trial was tied to the a dosing schedule based on traditional antibiotics. How awesome is it that the solution is to only use a single dose instead. The more one looks, the more there is to love about Brilacidin.

"All three Brilacidin treatment arms (two single-dose regimens and one three-day dose regimen) reached the primary endpoint, with the clinical success rate for each dosing regimen statistically comparable to the clinical success rate of the FDA-approved seven-day dosing regimen of daptomycin. All Brilacidin treatment regimens were well tolerated. There were six severe adverse events (SAE) reported across the study, none of which were considered related to Brilacidin by the principal investigator."

scgmck1

02/23/15 9:43 AM

#92290 RE: To infinity and beyond! #92287

There were no AE's associated with B in the 2B trial. The paresthesias (tingling) associated in the Poly trial was dose related and was eliminated with the lower dosage in CTIX's 2B trial as Dr. Menon thought it would. We are still on hold for bottom line results of the 2B Brilicidin trial. Copenhagen should be the canvass for releasing this vital information. We ARE NOT in a quiet period as someone earlier posted. There is simply no new news to release today.

slcimmuno

02/23/15 9:45 AM

#92291 RE: To infinity and beyond! #92287

F1lash posted the SAE clarification --
ECCMID LINKS

PRESENTATION
Synthetic novel host defense protein mimetics for the treatment of Gram-negative bacterial infections. Speaker: Siya Ram, CTIX Director of Chemistry
http://eccmid.meetingexpert.net/ECCMID_546/poster_122353/program.aspx

PRESENTATION
A randomized, double blind study comparing single dose and short course Brilacidin to Daptomycin in treatment of ABSSSI. Speaker Daniel Jorgensen, CTIX Chief Medical Officer
http://eccmid.meetingexpert.net/ECCMID_546/searchPresentation.aspx?option=Presentation&page=1

POSTER
Brilacidin, host defence peptide mimetic, one of a new class of immunomodulatory agents that can target multiple disease indications
http://eccmid.meetingexpert.net/ECCMID_546/poster_121449/program.aspx

N8 Medical also there
http://eccmid.meetingexpert.net/ECCMID_546/poster_120899/program.aspx

And here are all the Daptomycin Posters/Presentations/Sessions
http://eccmid.meetingexpert.net/ECCMID_546/search.aspx?stext=Daptomycin&soption=All

TheHound

02/23/15 9:55 AM

#92292 RE: To infinity and beyond! #92287

It's already qualified for fast track under QIDP.