AmpliPhi Biosciences Completes Enrollment of Its Investigational Phage Therapy Trial Targeting Staphylococcus aureus

Wednesday, August 3, 2016 8:45 am EDT


AmpliPhi Biosciences Corporation (NYSEMKT:APHB), a global leader in the development of bacteriophage-based antibacterial therapies to treat drug-resistant infections, today announced it has completed enrollment of its Phase 1 clinical trial to evaluate the safety of AB-SA01, its proprietary phage cocktail targeting Staphylococcus aureus (S. aureus) infections. The trial is being conducted under a Collaborative Research and Development Agreement with the U.S. Army at the Walter Reed Army Institute of Research (Walter Reed) Clinical Trials Center in Silver Spring, Maryland. AmpliPhi expects to report topline results by the end of the third quarter of 2016.

Bacteriophages, or, more simply, “phages”, are naturally-occurring viruses that have evolved to be highly selective for the bacterial species they must infect in order to replicate. Successful infection enables a single phage to hijack a bacterial host’s protein production machinery to rapidly produce hundreds of progeny phages, at which point the phage instructs the bacterial cell to burst, scattering the highly selective progeny into the surrounding environment to attack nearby bacteria and repeat the reproduction process until the bacterial population is depleted. Throughout this process the phages maintain their bacterial species selectivity, enabling a phage-based therapeutic to precisely target a pathogenic bacterial population while sparing the beneficial microbiota. Phage can infect and kill bacteria, whether they are antibiotic-resistant or not and even when they have formed protective biofilms. Such biofilms are a major line of defense for bacteria, sometimes rendering them impervious to conventional antibiotics.

Despite vigorous eradication efforts, S. aureus is one of the most common causes of hospital-acquired infections. It can cause pneumonia, infect prosthetic joints, skin and other soft tissues and is a leading cause of bloodstream infections – typically as a consequence of traumatic injury, surgery or use of catheters or injectable drugs – where it can go on to infect and damage the heart, joints and bones.

The double-blinded, placebo-controlled study began on May 24, 2016 and was designed to evaluate the safety of AB-SA01 administered topically to the skin of 12 healthy adult volunteers between the ages of 18 and 60. Volunteers were split into two cohorts of six participants each, and received either the low-dose (1 x 108 PFU/mL) or high-dose (1 x 109 PFU/mL) of AB-SA01, administered topically to the forearm under an occlusive bandage. Placebo was similarly administered to the volunteer’s opposite forearm, allowing each participant to serve as their own control. Participants received AB-SA01 and placebo daily for three consecutive days and were monitored following treatment.

“Successfully enrolling the first U.S.-based trial of AB-SA01 marks a signal achievement by the AmpliPhi team and our partners at Walter Reed as we work to pioneer the first rigorous human efficacy studies of phage therapy in the United States,” said M. Scott Salka, CEO of AmpliPhi Biosciences. “Phage therapy holds the potential to play a critical role in humanity’s fight against the looming and ever-evolving threat of antibiotic-resistant bacteria by exploiting a predator-prey relationship that has been raging since the dawn of life on Earth. We look forward to completing the necessary follow-up visits and providing more results soon, and expect to have complete study reports for both this trial as well as our Phase 1 AB-SA01 trial in patients with chronic rhinosinusitis later this year.”

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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 currently conducting a Phase 1 clinical trial of AB-SA01 for the treatment of S. aureus in chronic rhinosinusitis patients and another Phase 1 clinical trial to evaluate the safety of AB-SA01 when administered topically to the intact skin of healthy adults. AmpliPhi expects to report final data for both trials in the second half of 2016. AmpliPhi is also developing bacteriophage therapeutics targeting Pseudomonas aeruginosa and Clostridium difficile in collaboration with a number of leading organizations focused on the advancement of bacteriophage-based therapies.

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 expected timing of reporting data from AmpliPhi’s two AB-SA01 trials, the potential use of bacteriophages to treat bacterial infections, including infections that do not respond to antibiotics, the potential benefits of phage therapy, and AmpliPhi’s development of bacteriophage-based therapies. 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. These forward-looking statements are based upon AmpliPhi’s current expectations and involve a number of risks and uncertainties, including the risks and uncertainties described in AmpliPhi’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, as filed with the Securities and Exchange Commission. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. 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.



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