A patient suffering from a life-threatening staphylococcal endocarditis received AB-SA01 under expanded access regulatory guidelines
Public Company Information:
SAN DIEGO--(BUSINESS WIRE)--AmpliPhi Biosciences Corporation (NYSE American: APHB), a clinical-stage biotechnology company focused on the development of therapies for antibiotic-resistant infections using bacteriophage technology, announces the first-in-human intravenous administration of AmpliPhi’s drug candidate AB-SA01. AmpliPhi supplied AB-SA01 to a major hospital in Australia for a patient suffering from a life-threatening Staphylococcus aureus (S. aureus) infection of the heart (endocarditis). AB-SA01 was administered intravenously to the patient over two weeks and was well tolerated.
AmpliPhi provided AB-SA01 for the patient under Category A of the Australian Therapeutic Goods Administration’s (TGA) Special Access Scheme (SAS). The SAS is the TGA’s framework that enables the import and supply of unapproved therapeutics on a case-by-case basis for patients who have no other satisfactory treatment options. SAS Category A is specifically designated for patients who are seriously ill with a life-threatening condition.
AB-SA01 previously completed two Phase 1 clinical trials, including one in patients with chronic rhinosinusitis, administered as a sinus wash, and one in healthy volunteers, administered topically.
In August 2017, AmpliPhi announced the first-in-human administration of its therapeutic candidate AB-PA01 targeting Pseudomonas aeruginosa (P. aeruginosa) under an emergency IND allowed by the FDA. AmpliPhi provided AB-PA01 to a major U.S. teaching hospital for a patient suffering from a life-threatening multidrug-resistant P. aeruginosa lung infection. Multiple doses of AB-PA01 were administered both intravenously and by inhalation through a nebulizer and were well tolerated.
“We continue implementation of our strategy to work with leading infectious disease physicians in the United States and Australia and provide AmpliPhi’s therapeutic candidates to patients suffering from serious or life-threatening bacterial infections under expanded access guidelines,” said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. “Both AB-SA01 and AB-PA01 have now been administered intravenously to critically ill patients and were well tolerated. We expect the data from these and other expanded access cases to support the selection of indications for further clinical development in the first half of 2018 and, in consultation with the FDA, TGA and other regulatory agencies, define an efficient path to regulatory approval.”
Bacteriophages, or more simply “phages,” are the natural predators of bacteria and are thought to be the most abundant life form on earth. Phages have evolved an incredible diversity of strains that typically prey upon just a few closely related strains or species of bacteria, enabling phage therapies to precisely target pathogenic bacteria while sparing the beneficial microbiota. Phages can infect and kill bacteria, whether they are antibiotic-resistant or not, and even when they have formed protective biofilms.
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 target multidrug-resistant S. 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 about the potential benefits of phage therapy and the potential use of bacteriophages to treat bacterial infections, including infections that do not respond to antibiotics; AmpliPhi’s development of bacteriophage-based therapies; and AmpliPhi’s strategy for developing its lead therapeutic candidates through treatment of individual patients under expanded access guidelines, including using the data from the expanded access cases to support selection of indications for further clinical development in the first half of 2018 and define an efficient path to regulatory approval, and other potential benefits expected from this strategy. 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 AmpliPhi’s business and financial condition and the other risks and uncertainties described in AmpliPhi’s Annual Report on Form 10-K for the year ended December 31, 2016, as filed with the 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:
Matthew Dansey, 858-800-4869
LHA Investor Relations
Jody Cain, 310-691-7100
Russo Partners, LLC
David Schull or Maggie Beller