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Cellceutix Corp Brilacidin ABSSSI trial gets positive review by data safety monitoring board


Monday, 7 Jul 2014 07:00am EDT 

Cellceutix Corp:Says Company's phase 2b study on patients with acute bacterial skin and skin structure infections (ABSSSI), an independent Data Safety Monitoring Board (DSMB) gave positive review of interim safety data, collected after about 50 pct of subjects were enrolled.Says DSMB is composed of two cardiologists, one neurologist, and one statistician, and its mandate is to monitor and promote the safety of study participants.Says DSMB recommended that Cellceutix continue the trial as planned.Says independent experts did not observe any concerning safety signals in the study.In addition, the Company reports there are no treatment-related Serious Adverse Events (SAEs), and none classified as cardiovascular or neurological, thus far in the study.Says any treatment-related adverse events in past trials were more likely due to a higher total dose of study drug.However, in the current study, brilacidin is given as a single-dose regimen in two treatment arms (0.6 or 0.8 mg/kg) and in the third arm, it is given as a 3-day regimen, which represents the highest amount a subject could receive (total 1.2 mg/kg).Says of note, the highest amount is still lower than the lowest amount of brilacidin given in the previous phase 2 ABSSSI study, which concluded in 2012. 

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23 Jul 2014