PUBLIC COMPANY INFORMATION:
SAN DIEGO–(BUSINESS WIRE)–AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, today announced a collaboration with the Western Sydney Local Health District and the Westmead Institute for Medical Research, based in Sydney, Australia. The agreement covers compassionate use treatment of patients with severe Staphylococcus aureus and Pseudomonas aeruginosa infections with AmpliPhi’s investigational bacteriophage therapeutics AB-SA01 and AB-PA01.
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.”
About AmpliPhi Biosciences
AmpliPhi Biosciences Corporation is a clinical-stage biotechnology company focused on treating antibiotic-resistant infections using its proprietary bacteriophage-based technology. AmpliPhi’s lead product candidates, AB-SA01 and AB-PA01, target multidrug-resistant Staphylococcus aureus and Pseudomonas aeruginosa, which are included on the WHO’s 2017 Priority Pathogens List. Phage therapeutics are uniquely positioned to address the threat of antibiotic-resistance as they can be precisely targeted to kill select bacteria, have a differentiated mechanism of action, can penetrate and disrupt biofilms (a common bacterial defense mechanism against antibiotics), are potentially synergistic with antibiotics and have been shown to restore antibiotic sensitivity to drug-resistant bacteria. For more information visit www.ampliphibio.com.
Forward Looking Statements
Statements in this press release that are not statements of historical fact are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, without limitation, statements regarding: the agreement with Western Sydney Local Health District and the Westmead Institute for Medical Research, including the expected acceleration of the collaboration to supply AB-SA01 and AB-PA01 for additional patients with serious and life-threatening infections; AmpliPhi’s plan to present data from expanded access clinical cases 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; and the potential benefits of phage therapy and the potential use of bacteriophages to treat bacterial infections, including infections that do not respond to antibiotics or are associated with biofilms. Words such as “believe,” “anticipate,” “plan,” “expect,” “intend,” “will,” “may,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. Among the factors that could cause actual results to differ materially from those indicated in these forward-looking statements are risks and uncertainties associated with bacteriophage product candidate development, both generally and specifically through expanded access regulations, AmpliPhi’s financial condition, and other risks and uncertainties described in AmpliPhi’s Annual Report on Form 10-K for the year ended December 31, 2017, as filed with the Securities and Exchange Commission (SEC), and AmpliPhi’s subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and AmpliPhi undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.
At the Company:
Robert H. Uhl
Russo Partners, LLC
David Schull or Maggie Beller