SAN DIEGO, April 20, 2016– Link here. AmpliPhi Biosciences Corporation (NYSEMKT: APHB), a global leader in the development of bacteriophage-based antibacterial therapies to treat drug-resistant infections, today provided an update on the progress of its ongoing first-in-man Phase I clinical trial for chronic rhinosinusitis patients treated with AmpliPhi’s proprietary phage cocktail AB-SA01.
The first cohort, in which three patients were administered AB-SA01 twice daily for seven days, has been completed. Treatment was well tolerated and there were no apparent drug-related adverse events. The first patient in cohort two has been enrolled and is being treated with the same dose, twice daily for 14 days.
M. Scott Salka, CEO of AmpliPhi Biosciences, commented: “Bacteriophages are abundantly found in and around humans. This fact, combined with our initial clinical results, bolsters our expectation that phage therapy will prove to be safe and well tolerated. We are also encouraged that the preliminary data indicate decreased bacterial loads and an easing of symptoms following treatment. We look forward to treating the patients that will comprise cohorts two and three in which we will evaluate both longer treatment durations and a higher dose. We expect to complete the trial mid-year and report final data later in 2016.”
In an episode aired on April 19, 2016, the Australian Broadcast Company’s TV show, “Catalyst”, interviewed one of the patients in the trial as well as the trial’s Principal Investigator, Dr. Peter-John Wormald, during a segment highlighting phage therapy and its potential role in the fight against antibiotic resistant bacteria. The video can be found at http://www.abc.net.au/catalyst/stories/4446258.htm. The segment begins at the 23:28 minute mark and ends at 26:45.
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 Staphylococcus aureus in chronic rhinosinusitis patients and expects to report final data 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.
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. Bacteriophage are unaffected by antibiotic resistance and are able to disrupt bacterial biofilms. Such biofilms are a major line of defense for bacteria, contributing to antibiotic resistance. Bacteriophage are able to penetrate biofilms and replicate locally to high levels, to 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 Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, without limitation, statements regarding the extent to which phage therapy will be proven to be safe and well tolerated and other expected or implied future clinical results, the expected timing for reporting final data from the AB-SA01 trial, the potential use of bacteriophages to treat bacterial infections, including infections that do not respond to antibiotics, 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 Annual Report on Form 10-K for the year ended December 31, 2015, 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.