AmpliPhi Biosciences Corporation (NYSEMKT: APHB), a biotechnology company focused on the development and commercialization of novel bacteriophage-based antibacterial therapeutics, today announced topline results from its Phase 1 trial to evaluate the safety and tolerability of AB-SA01, its proprietary investigational phage cocktail targeting Staphylococcus aureus (S. aureus) infections in patients suffering from chronic rhinosinusitis (CRS). Enrollment in the trial has been completed and the Safety Monitoring Committee overseeing the trial has determined that AB-SA01 was well-tolerated by all nine patients and that there were no drug-related serious adverse events.
“We believe that completing enrollment of our two Phase 1 clinical trials of AB-SA01 in 2016 and the favorable topline results we've seen from them will pave the way for AmpliPhi to initiate Phase 2 clinical trials in 2017,” said M. Scott Salka, CEO of AmpliPhi Biosciences. “Controlled efficacy studies of phage therapy have yet to be conducted under modern regulatory requirements, making these pioneering studies potentially significant milestones not just for AmpliPhi, but for the entire emerging field of phage therapy. I would like to thank the entire AmpliPhi team as well as our partners for their contributions toward meeting theses important goals that bring us closer to our mission of delivering better treatment to patients suffering from chronic infections. We look forward to reporting complete study results later this year.”
The Phase 1 clinical trial in CRS patients was initiated in January 2016 and was conducted at the Queen Elizabeth Hospital in collaboration with the University of Adelaide and Flinders University. Nine patients were enrolled in the trial and received AB-SA01 in one of three different dose regimens: Cohort 1—low dose, twice daily for seven days; Cohort 2—low dose, twice daily for 14 days; and, Cohort 3—high dose, twice daily for 14 days. AmpliPhi expects to report complete trial results by the end of 2016.
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 has reported topline results from two Phase 1 clinical trials of AB-SA01, one for the treatment of S. aureus in chronic rhinosinusitis patients and one to evaluate the safety of AB-SA01 when administered topically to the intact skin of healthy adults. AmpliPhi expects to report final data from each trial by the end of 2016. AmpliPhi is also developing bacteriophage therapeutics targeting Pseudomonas aeruginosa (P. aeruginosa) and Clostridium difficile (C. 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, producing hundreds of offspring viruses in the process. Bacteriophage are unaffected by antibiotic resistance and are able to disrupt bacterial biofilms, which are a major line of defense for bacteria and help them resist antibiotics. Bacteriophage can effectively penetrate biofilms to produce strong local therapeutic effects without destroying bacteria important to normal human health.
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 final data from AmpliPhi’s two AB-SA01 trials, the expected timing of initiating Phase 2 clinical 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 June 30, 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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Last updated on: 25/10/2016
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