AmpliPhi signs deal with Australian university to conduct phase I trial of bacteriophage therapy

The study is titled "A Phase I Investigator Initiated Study to Evaluate the Safety, Tolerability and Preliminary Effectiveness of AB-SA01 in Patients with Chronic Rhinosinusitis Associated with Staphylococcus aureus Infection".

The single-site trial will be conducted at the Queen Elizabeth Hospital, Adelaide, Australia and sponsored by the University of Adelaide.

AmpliPhi will supply the bacteriophage drug product for the clinical study (which was manufactured in AmpliPhi’s cGMP facility in Ljubljana, Slovenia), provide certain financial support, and assist with study coordination and monitoring laboratory testing.

Additionally, AmpliPhi will provide scientific input, protocol recommendations and assist the study’s principal investigator with data management support.

AmpliPhi Biosciences CEO Scott Salka said: "This Phase I clinical study represents a significant step for AmpliPhi on our mission to attack the rising menace of drug-resistant bacterial infections.

"We are proud to be working with Dr. Peter-John Wormald and the entire team at the University of Adelaide and the Queen Elizabeth Hospital to advance our novel bacteriophage-based therapy into the clinic and demonstrate the potential of phage therapy to provide relief to the millions of patients ravaged every year by antibiotic-resistant bacteria."

The first lot of bacteriophage AB-SA01 has been released from AmpliPhi’s Slovenian manufacturing facility and shipped to Australia. AmpliPhi and the University of Adelaide are currently in the final stages of trial preparation. The trial is expected to enroll nine patients and is anticipated to start with the dosing of the first patient in the next few weeks.