Full Press Release Details
AmpliPhi Biosciences Announces Presentation of Positive Clinical
Data From its Expanded Access Program for Serious S. aureus Infections at IDWeek 2018 Conference
13 patients with serious and life-threatening
S. aureus infections were treated with AB-SA01 at the Westmead Hospital in Sydney under AmpliPhi's expanded access program
Patients suffered from severe S. aureus bacteremia
and sepsis, including infective endocarditis and prosthetic valve endocarditis
83% (10 out of 12) patients in the modified intent-to-treat
(mITT) population achieved treatment success at the end of therapy as reported by treating physicians
Bacteriophage treatment was well tolerated, with
no adverse events attributable to the therapy
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 the presentation of clinical case series data from the company's ongoing expanded access program
for its investigational bacteriophage therapeutic, AB-SA01 targeting Staphylococcus aureus (S. aureus), at the IDWeek 2018 conference
Prof. Jonathan Iredell, Senior Staff Infectious Diseases Physician
at the Westmead Hospital in Sydney, Director of Centre for Infectious Diseases and Microbiology at the Westmead Institute of Medical
Research and Professor of Medicine and Microbiology at the University of Sydney, gave a presentation "Adjunctive bacteriophage
therapy for severe Staphylococcal sepsis," including data on 13 patients suffering from severe S. aureus infections, who
were treated with AB-SA01 as an adjunct to antibiotics at the Westmead Hospital in 2017-2018. The potential treatment of S. aureus
bacteremia with AB-SA01 was also the subject of the Company's recent Type B meeting with the FDA. The treatment was conducted
under emergency protocols per the Australian Therapeutic Goods Administration's (TGA) Special Access Scheme (SAS).
Highlights from the presentation include the following:
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 clinical stage 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.
About Bacteriophages
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.
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 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.
AmpliPhi Biosciences
Steve Martin, 858-800-2492
Robert H. Uhl, 858-356-5932