AmpliPhi Biosciences (APHB) Updates on AB-SA01 Phase 1 in Chronic Rhinosinusitis; Sees Topline Data Later in 2016
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AmpliPhi Biosciences Corporation (NYSE: APHB) announced an update on the progress of its ongoing Phase 1 clinical trial for the treatment of S. aureus infections in patients suffering from chronic rhinosinusitis with AmpliPhi’s proprietary and investigational phage cocktail AB-SA01.
The Phase 1 clinical trial was initiated in January 2016 and is being conducted at the Queen Elizabeth Hospital in collaboration with the University of Adelaide and Flinders University. A total of nine patients are expected to be dosed in the trial, in three equal cohorts: Cohort 1—low dose, twice daily for seven days; Cohort 2—low dose, twice daily for 14 days; and Cohort 3—high dose, twice daily for 14 days. To date, seven patients have completed dosing and the final two patients are expected to be enrolled shortly. We expect to report topline results and final results from this trial later this year.
The preliminary safety results for the first seven patients indicate AB-SA01 was well tolerated; no body temperature variability throughout the treatment period and no difference in blood panels before and after dosing was observed. No drug-related serious adverse events were reported.
The primary outcome of eradication of S. aureus was achieved in two of the three patients in Cohort 2 and zero of three patients in Cohort 1. In both Cohorts 1 and 2, patients reported improvements in symptoms, as measured on days 0, 7 and 14 by Visual Analogue Scale (VAS) and Sino-Nasal Outcome Test (SNOT-22) score. In Cohort 2, there have been improvements post treatment in endoscopic video examinations using the Lund Kennedy Score.
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