Date: 2016-04-20
Type of information: Interim results
phase: 1
Announcement: interim results
Company: AmpliPhi BioSciences (USA - VA)
Product: AB-SA01 (phage cocktail targeting Staphylococcus aureus)
Action
mechanism: bacteriophage
Disease: Staphylococcus aureus infections in patients with chronic rhinosinusitis
Therapeutic area: Infectious diseases
Country: Australia
Trial details:
Latest
news: * On April 20, 2016, AmpliPhi Biosciences provided an update on the progress of its ongoing first-in-man Phase I clinical trial for chronic rhinosinusitis patients treated with AmpliPhi’s proprietary phage cocktail AB-SA01. The first cohort, in which three patients were administered AB-SA01 twice daily for seven days, has been completed. Treatment was well tolerated and there were no apparent drug-related adverse events. The first patient in cohort two has been enrolled and is being treated with the same dose, twice daily for 14 days. M. Scott Salka, CEO of AmpliPhi Biosciences, commented: “Bacteriophages are abundantly found in and around humans. This fact, combined with our initial clinical results, bolsters our expectation that phage therapy will prove to be safe and well tolerated. We are also encouraged that the preliminary data indicate decreased bacterial loads and an easing of symptoms following treatment. We look forward to treating the patients that will comprise cohorts two and three in which we will evaluate both longer treatment durations and a higher dose. We expect to complete the trial mid-year and report final data later in 2016.” * On January 20, 2016, AmpliPhi Biosciences announced it has dosed the first patient in its Phase 1 clinical trial of AB-SA01 for the treatment of Staphylococcus aureus (S. aureus) infections in patients with chronic rhinosinusitis (CRS) that fail to respond to standard antibiotic treatment. AmpliPhi’s Phase 1 clinical trial is enrolling patients with CRS – defined as serious, often debilitating infection and inflammation of the nose and sinuses lasting 12 weeks or more – who have not responded to surgery and are infected with S. aureus. AmpliPhi expects to complete enrollment of the trial by the end of the first half of 2016. Last November, AmpliPhi Biosciences has entered into a Clinical Trial Research Agreement with the University of Adelaide for the purpose of conducting this Phase I clinical study.
