for its Expanded Access Program
- 21 patients at 7 hospitals, with serious or life-threatening infections not responding to antibiotics, have now been treated with AB-SA01 (targeting S. aureus) or AB-PA01 (targeting P. aeruginosa) under AmpliPhi’s expanded access program
- Over 1,000 doses of bacteriophage product candidates, AB-SA01 or AB-PA01, have been administered as part of the expanded access program since mid-2017 and have been generally well tolerated, with no serious adverse events attributable to bacteriophage treatment
- 84% of patients achieved treatment success at the end of therapy
AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, today announced updated topline clinical results for its ongoing single-patient expanded access program. 84% of patients achieved treatment success (physician’s assessment) at the end of therapy, defined as complete resolution or significant improvement of baseline signs and symptoms.
AmpliPhi has now provided its investigational bacteriophage therapeutics for a total of 21 patients, at 7 hospitals, with serious or life-threatening infections not responding to antibiotic therapy. These patients were treated with AB-SA01 or AB-PA01 under single-patient expanded access programs in the U.S. (Emergency INDs per the U.S. Food and Drug Administration) or Australia (Special Access Scheme per the Australian Therapeutic Goods Administration). The following analysis updates the data previously announced by the company on January 3, 2018 … read more