Replies to post #453 on Armata Pharmaceuticals, Inc. (ARMP)

[Rogerthat1]

AmpliPhi Biosciences Announces Favorable Topline Safety and Tolerability Results from Its Phase 1 Trial in Patients with Chronic Rhinosinusitis

Business Wire October 25, 2016
SAN DIEGO--(BUSINESS WIRE)--
AmpliPhi Biosciences Corporation (APHB), a biotechnology company focused on the development and commercialization of novel bacteriophage-based antibacterial therapeutics, today announced topline results from its Phase 1 trial to evaluate the safety and tolerability of AB-SA01, its proprietary investigational phage cocktail targeting Staphylococcus aureus (S. aureus) infections in patients suffering from chronic rhinosinusitis (CRS). Enrollment in the trial has been completed and the Safety Monitoring Committee overseeing the trial has determined that AB-SA01 was well-tolerated by all nine patients and that there were no drug-related serious adverse events.

“We believe that completing enrollment of our two Phase 1 clinical trials of AB-SA01 in 2016 and the favorable topline results we've seen from them will pave the way for AmpliPhi to initiate Phase 2 clinical trials in 2017,” said M. Scott Salka, CEO of AmpliPhi Biosciences. “Controlled efficacy studies of phage therapy have yet to be conducted under modern regulatory requirements, making these pioneering studies potentially significant milestones not just for AmpliPhi, but for the entire emerging field of phage therapy. I would like to thank the entire AmpliPhi team as well as our partners for their contributions toward meeting theses important goals that bring us closer to our mission of delivering better treatment to patients suffering from chronic infections. We look forward to reporting complete study results later this year.”
The Phase 1 clinical trial in CRS patients was initiated in January 2016 and was conducted at the Queen Elizabeth Hospital in collaboration with the University of Adelaide and Flinders University. Nine patients were enrolled in the trial and received AB-SA01 in one of three different dose regimens: 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. AmpliPhi expects to report complete trial results by the end of 2016.