AmpliPhi Biosciences Corporation (NASDAQ:APHB) Files An 8-K Other Events
Item 8.01 Other Events.
On December 19, 2016, we issued a press release reporting final
results from our Phase 1 trial of AB-SA01, our proprietary
investigational bacteriophage cocktail targeting
Staphylococcus aureus (S. aureus) infections,
in patients with chronic rhinosinusitis. AB-SA01 met the trials
primary endpoints of safety and tolerability and all nine
patients enrolled in the study experienced a reduction in the
quantity of S. aureus infecting their sinuses, with some
patients showing complete eradication of the bacterial infection.
The trial was initiated in January 2016 and was conducted at the
Queen Elizabeth Hospital in Adelaide, Australia in collaboration
with the University of Adelaide and Flinders University. All nine
patients enrolled received AB-SA01 in one of three dose regimens:
Cohort 1 patients received low-dose twice daily for seven days;
Cohort 2 patients received low-dose twice daily for 14 days; and
Cohort 3 patients received high-dose twice daily for 14 days.
Key findings from the study showed:
| Primary endpoints of safety and tolerability were met |
|
All patients experienced a reduction in S. aureus bacterial load at the end of the study compared to baseline |
|
Comparison of pre- and post-treatment endoscopic images showed symptomatic improvement, including reductions in mucosal edema, discharge and polyps |
| All enrolled patients completed the trial |
About AmpliPhi Biosciences Corporation (NASDAQ:APHB)
