Full Press Release Details
AmpliPhi Biosciences Announces a New
Strategic Emphasis on
Personalized Therapies for Serious or
Life-Threatening Antibiotic-Resistant Infections
1, 2017) - AmpliPhi Biosciences Corporation (NYSE MKT: APHB), a leader in the field of bacteriophage technology, announces
a new strategic emphasis on precisely targeted and personalized medicines designed to address the surging global threat posed by
bacteria that have become resistant to antibiotics. Under existing compassionate-use guidelines, AmpliPhi expects to provide personalized
phage therapies to patients suffering from severe, multidrug-resistant (MDR) infections who have failed prior therapies. In addition
to offering hope to patients and families in dire need, the clinical data from these compassionate-use cases are expected to support
the potential validation of the clinical utility of phage therapy and inform discussions with the U.S. Food and Drug Administration
(FDA) on defining a potential path to market approval.
Bacteriophage are thought to be the most abundant and diverse
life form on Earth. Members of this family of viruses have evolved to fulfill one mission: to invade bacteria in order to replicate
in a process that destroys the bacterial host. These natural-born bacteria killers terminate their prey differently than conventional
antibiotic drugs, making them ideal natural elements in a new class of therapeutics with the potential to safely and precisely
destroy even the most highly antibiotic-resistant bacteria. Bacteriophages also have shown synergistic effects when combined with
traditional antibiotic therapies as demonstrated in both clinical and preclinical studies.
In the official minutes from a recent telephonic Type B meeting
with the FDA and in the context of discussing personalized therapies, the FDA "stated that the clinical safety and effectiveness
data collected during development, including from emergency case studies, could inform future discussions for clinical development
and ultimately, the regulatory pathway to approval." The FDA also "acknowledged that phage therapy is an exciting approach
to treatment of multidrug-resistant organisms and expressed a commitment to addressing the unique regulatory challenges that might
arise during product development."
Personalized phage therapies will initially be made available
in Australia, where AmpliPhi plans to collaborate with leading hospitals and key opinion leaders to identify and select eligible
patients. This new emphasis on personalized medicine builds upon AmpliPhi's prior successes using tailored bacteriophage
therapies under emergency INDs to treat individual patient battling life-threatening, MDR bacterial pathogens who had exhausted
their treatment options.
As previously reported, in March 2016 AmpliPhi collaborated
with several academic institutions and a U.S. Navy laboratory to produce a personalized bacteriophage therapy that successfully
treated a critically ill, comatose patient with an MDR Acinetobacter baumannii (A. baumannii) infection. Shortly
after phage therapy was initiated, the patient emerged from the coma and continued to improve under an ongoing combination of phage
and antibiotic therapies until the infection was cleared. To date, the infection has not returned.
Additionally, AmpliPhi's wholly owned subsidiary, Special
Phage Services, was instrumental in developing a personalized phage therapy that eliminated an antibiotic-resistant Pseudomonas
aeruginosa (P. aeruginosa) infection in the bladder of a female cancer patient. The results of this case were published
in a manuscript in the Journal of Medical Microbiology in 2011.
Dr. Jonathan Iredell, Professor of Medicine and Microbiology
at the University of Sydney and Westmead Institute of Medical Research, Director, Infectious Diseases, Westmead Hospital, who treated
the bladder cancer patient and is the corresponding author of the manuscript, said, "Bacteriophage therapy holds high promise
for treating serious, resistant bacterial infections and for providing much-needed new therapeutic options for patients. I believe
this therapeutic modality needs to be rapidly explored in a clinical setting to better understand its potential and make it available
Starting with samples taken from infected patients, AmpliPhi
expects to be able to screen its bacteriophage libraries to craft patient-tailored therapies. Treatment of MDR Staphylococcus
aureus (S. aureus) or P. aeruginosa infections could start within as little as a few days of receiving the infected
patient samples since AmpliPhi already has broadly active, clinical-trial ready phage mixtures against these more common pathogens.
For other pathogens, the Company expects in many cases to be able to develop personalized bacteriophage therapies within approximately
two weeks of receiving the infected patient samples, as demonstrated in the recent A. baumannii infection case.
AmpliPhi is also seeking opportunities to advance its chronic
rhinosinusitis (CRS) program (positioned for a Phase 2 trial) and preclinical cystic fibrosis (CF) program through partnerships
and non-dilutive funding.
AmpliPhi had cash and cash equivalents of $2.2 million as of
March 31, 2017, and has made operational changes that are expected to reduce its cash expenditures in 2017 and support its strategic
emphasis on precisely targeted personalized bacteriophage therapies. The Company has filed its Australian tax return and
now expects the receipt of a $1.8 million tax incentive payment early in the third quarter of 2017, subject to review by the Australian
About Antibiotic Resistance
Decades of misuse and over-use of antibiotics has led to the
rise of multidrug-resistant and pan-resistant bacteria, commonly known as "superbugs." These superbugs threaten to
render existing antibiotic therapies useless, potentially thrusting the world into a "post-antibiotic" era where common
infections may be life threatening. Hospitals regularly expose vulnerable patients to pathogenic bacteria. According to the World
Health Organization each year hundreds of millions of patients worldwide suffer from infections acquired in a hospital setting.
The Centers for Disease Control and Prevention (CDC) estimates that drug-resistant bacteria cause at least 2 million infections
per year in the U.S. alone, resulting in over 23,000 deaths and many more people die from other conditions that are complicated
by antibiotic-resistant infections. The 2016 O'Neill Report commissioned by the UK government projects that the failure to
respond to the threat of antibiotic resistance and the rise of superbugs could lead to an estimated 10 million deaths per year
from antibiotic-resistant infections worldwide by 2050, with an accumulated global cost of $100 trillion and a 3.5% reduction in
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. Over eons, phages have evolved an incredible
diversity of specialist strains that typically prey upon just one strain 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 biotechnology company
pioneering the development and commercialization of therapies for antibiotic-resistant infections using bacteriophage-based technology.
In May 2017, AmpliPhi announced a new strategic emphasis on developing precisely targeted and personalized bacteriophage therapies
for patients with serious or life-threatening antibiotic-resistant infections. AmpliPhi has reported results from two Phase 1
clinical trials of AB-SA01, one for the treatment of S. aureus in chronic rhinosinusitis patients (safety and preliminary
efficacy) and one to evaluate the safety of AB-SA01 when administered topically to the intact skin of healthy adults. 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 use of bacteriophages to treat bacterial
infections, the Company's ability to develop targeted and personalized medicines for patients with serious or life-threatening
antibiotic-resistant infections, the Company's ability to advance its research and development programs through partnerships
and non-dilutive funding, the regulatory pathway for approval of phage therapies, the potential benefits of phage therapies, the
Company's cash runway and expected receipt of cash payments. 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 other filings with the SEC, including our Current Report on Form 8-K filed with the SEC on May
1, 2017. 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
AmpliPhi Biosciences