Date: 2015-11-19
Type of information: Clinical research agreement
Compound: AB-SA01
Company: AmpliPhi BioSciences (USA - VA) University of Adelaide (Australia)
Therapeutic area: Infectious diseases
Type agreement: clinical research
Action mechanism: bacteriophage.
Disease: chronic rhinosinusitis associated with Staphylococcus aureus infection
Details: * On November 19, 2015, AmpliPhi Biosciences announced that it has entered into a Clinical Trial Research Agreement with the University of Adelaide for the purpose of conducting a Phase I clinical study. 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 with support from Flinders University. 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. 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.
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