SAN DIEGO & RICHMOND, Va. & LJUBLJANA, Slovenia & SYDNEY--(BUSINESS WIRE)--AmpliPhi Biosciences Corporation (NYSEMKT:APHB), a global leader in the development of bacteriophage-based antibacterial therapies to treat drug-resistant infections, today announced that it has entered into a Clinical Trial Research Agreement with the University of Adelaide for the purpose of conducting a Phase I clinical study. The study is titled “A Phase I Investigator Initiated Study to Evaluate the Safety, Tolerability and Preliminary Effectiveness of AB-SA01 in Patients with Chronic Rhinosinusitis Associated with Staphylococcus aureus Infection”.
The single-site trial will be conducted at the Queen Elizabeth Hospital, Adelaide, Australia and sponsored by the University of Adelaide. AmpliPhi will supply the bacteriophage drug product for the clinical study (which was manufactured in AmpliPhi’s cGMP facility in Ljubljana, Slovenia), provide certain financial support, and assist with study coordination and monitoring laboratory testing. Additionally, AmpliPhi will provide scientific input, protocol recommendations and assist the study’s principal investigator with data management support.
M. Scott Salka, CEO of AmpliPhi Biosciences, said: “This Phase I clinical study represents a significant step for AmpliPhi on our mission to attack the rising menace of drug-resistant bacterial infections. We are proud to be working with Dr. Peter-John Wormald and the entire team at the University of Adelaide and the Queen Elizabeth Hospital to advance our novel bacteriophage-based therapy into the clinic and demonstrate the potential of phage therapy to provide relief to the millions of patients ravaged every year by antibiotic-resistant bacteria.”
The first lot of bacteriophage AB-SA01 has been released from AmpliPhi’s Slovenian manufacturing facility and shipped to Australia. AmpliPhi and the University of Adelaide are currently in the final stages of trial preparation. The trial is expected to enroll nine patients and is anticipated to start with the dosing of the first patient in the next few weeks.
About AmpliPhi Biosciences
AmpliPhi Biosciences Corporation (NYSEMKT: APHB) is a biotechnology company focused on the development and commercialization of novel bacteriophage-based antibacterial therapeutics. AmpliPhi's product development programs target infections that are often resistant to existing antibiotic treatments. AmpliPhi is collaborating with a number of leading organizations, including Intrexon Corporation (NYSE: XON), the U.S. Army, The Royal Brompton Clinic in London, UK and UK-based University of Leicester, to rapidly advance bacteriophage-based therapies. For more information, visit www.ampliphibio.com.
Bacteriophage are naturally occurring viruses that are highly specific for the bacterial hosts they infect. They can rapidly kill their host, amplifying themselves in the process to kill neighbouring bacteria. Bacteriophage are unaffected by antibiotic resistance and are able to disrupt bacterial biofilms, a major line of defense for bacteria. By penetrating biofilms and replicating locally to high levels, bacteriophage can produce strong, local therapeutic effects.
Forward Looking Statements
Statements in this press release that are not statements of historical fact are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, without limitation, statements regarding the expected timing of first patient dosing in the Phase 1 clinical study, the number of patients to be enrolled, the drug product to be supplied by AmpliPhi for the clinical study, the activities to be performed by the parties in connection with the clinical study, the expected benefits or results from the clinical study, the potential use of bacteriophages to treat bacterial infections, and the development of bacteriophage-based therapies. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. These forward-looking statements are based upon expectations at the time the statements were made and involve assumptions that may never materialize or that may prove to be incorrect, and are subject to various risks and uncertainties, including, without limitation: risks and uncertainties associated with AmpliPhi’s ability to successfully manufacture and supply sufficient quantities of drug product for the clinical study; difficulties that may be encountered with enrolling patients in the clinical study; safety or efficacy issues that may arise during or after the clinical study; and the risk that the clinical study will not produce sufficiently positive, conclusive or otherwise successful results. These and other risks and uncertainties are described in additional detail in AmpliPhi’s filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the fiscal year ended December 31, 2014, as amended, and its subsequently filed quarterly reports on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. AmpliPhi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.