Update on cohort 2 of the B-UP trial: "Site inv
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Posted On: 01/28/2017 7:01:53 PM
Update on cohort 2 of the B-UP trial:
"Site investigators report enthusiastic feedback from patients currently receiving treatment in the second cohort with Brilacidin at 100 mg daily (by retention enema) for six weeks — comments included how the treatment already has greatly improved or eliminated their symptomatic complaints, daily functioning and overall quality of life . There is significant interest by new patients wishing to participate in the third (final) cohort once enrollment opens."
Summary of cohort 1:
"The initial data showed Brilacidin to be well-tolerated with no severe adverse events reported and no detection of measurable systemic absorption. Preliminary review of endoscopic images and video from Screening and Day 42 in patients in the first cohort showed meaningful improvements for 5 of the 6 patients, including noticeable reductions in ulceration and bleeding ."
Significance of cohort 1 data:
"Endoscopic assessments, pharmacokinetic profiles, as well as patient/physician-reported outcomes, collectively, suggest that, even at the lowest dosing level (50 mg), Brilacidin offers potential to deliver a clinically meaningful, safe, and expedient therapeutic response among trial participants . These are the positive signals one looks for in a Proof-of-Concept study, to attract partnering companies."
http://www.cellceutix.com/press-release/2017/...d-outcomes
Don't let AF distract you from what's going on in the trial.
"Site investigators report enthusiastic feedback from patients currently receiving treatment in the second cohort with Brilacidin at 100 mg daily (by retention enema) for six weeks — comments included how the treatment already has greatly improved or eliminated their symptomatic complaints, daily functioning and overall quality of life . There is significant interest by new patients wishing to participate in the third (final) cohort once enrollment opens."
Summary of cohort 1:
"The initial data showed Brilacidin to be well-tolerated with no severe adverse events reported and no detection of measurable systemic absorption. Preliminary review of endoscopic images and video from Screening and Day 42 in patients in the first cohort showed meaningful improvements for 5 of the 6 patients, including noticeable reductions in ulceration and bleeding ."
Significance of cohort 1 data:
"Endoscopic assessments, pharmacokinetic profiles, as well as patient/physician-reported outcomes, collectively, suggest that, even at the lowest dosing level (50 mg), Brilacidin offers potential to deliver a clinically meaningful, safe, and expedient therapeutic response among trial participants . These are the positive signals one looks for in a Proof-of-Concept study, to attract partnering companies."
http://www.cellceutix.com/press-release/2017/...d-outcomes
Don't let AF distract you from what's going on in the trial.
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