AmpliPhi Biosciences Announces Favorable Topline Safety & Tolerability Results from Its Phase 1 Trial in Patients with Chroni...
October 25 2016 - 9:20AM
Business Wire
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.
About Bacteriophage
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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version on businesswire.com: http://www.businesswire.com/news/home/20161025006045/en/
Company and Investor relations:AmpliPhi
BiosciencesMatthew Dansey+1
858-800-4869md@ampliphibio.comorMedia relations (USA)Lazar
PartnersDanielle Lewis/Glenn Silver+ 1
212-867-1762ampliphi@lazarpartners.comorMedia Relations (Europe
and ROW)Instinctif PartnersGemma Howe/Sue Charles+44 (0)20 7866
7860ampliphi@instinctif.com
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