AmpliPhi Biosciences Corporation announced a collaboration with the Western Sydney Local Health District and the Westmead Institute for Medical Research, based in Sydney, Australia.
To date, several critically ill patients have received AB-SA01 or AB-PA01 at the Westmead Hospital, under the Australian Therapeutic Goods Administration’s Special Access Scheme guidelines. In January, AmpliPhi announced positive interim results from the first patients treated under its single-patient expanded access program, including patients treated at the Westmead Hospital. This new agreement will expand and is expected to accelerate the collaboration to supply AB-SA01 and AB-PA01 for additional patients with serious and life-threatening infections, who do not respond to antibiotics, while collecting clinical and microbiological data.
“I’m delighted to expand the partnership with AmpliPhi and make these investigational bacteriophage treatments available for critically ill patients who have few or no other treatment options,” said Dr. Jonathan Iredell, Senior Staff Infectious Diseases Physician and Clinical Microbiologist at the Westmead Hospital, Professor of Medicine and Microbiology at the University of Sydney and Westmead Institute of Medical Research, and the Principal Investigator. “The promising clinical results I have observed to-date support the potential of bacteriophage therapeutics to be a safe and potent adjunct treatment for serious bacterial infections.”
“We are pleased to strengthen the relationship with our partners at the Westmead in Sydney, who have had a major role in our expanded access program, and administered AmpliPhi’s potentially life-saving treatments to seriously ill patients,” added Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. “AmpliPhi’s objective is to bring the data collected under our expanded access approach to the FDA in mid-2018, obtain feedback on the path to regulatory approval, and potentially initiate a Phase 2 or registrational clinical study as early as the second half of 2018.”
