AmpliPhi Biosciences Announces Positive Interim Results for Single-Patient Expanded Access Program Utilizing AB-SA01 and AB-P...
January 03 2018 - 4:05PM
Business Wire
- Seven patients with serious,
life-threatening infections, not responding to antibiotics, were
treated with AB-SA01 or AB-PA01, with six patients, 86%, achieving
treatment success
- Treatment was well tolerated in all
patients, with over 500 doses administered intravenously or by
inhalation
- AmpliPhi expects to continue its
expanded access clinical strategy in 2018, review data with the FDA
in mid-2018, and initiate a Phase 2 or registrational clinical
program potentially as early as the second half of 2018
- Management will host webcast/conference
call today at 4:30 p.m. EST/1:30 p.m. PST
AmpliPhi Biosciences Corporation (NYSE American: APHB), a
clinical-stage biotechnology company focused on precisely targeted
bacteriophage therapeutics for antibiotic-resistant infections,
today announced topline results for the first seven patients
treated under its ongoing single-patient expanded access program.
Six of the seven patients (86%) achieved treatment success
(physician’s assessment), defined as complete resolution or
significant improvement of baseline signs and symptoms. All
patients were severely ill and unresponsive to antibiotic treatment
at the time of enrollment.
“I am very encouraged by these initial results for treatment
with AB-SA01 or AB-PA01 in severely ill patients who were not
responding to antibiotics,” stated Paul C. Grint, M.D., CEO of
AmpliPhi Biosciences. “We look forward to treating up to an
additional 20 patients during the first half of 2018 and discussing
our findings with the FDA to determine a development path forward
to registration. Our ongoing dialogue with infectious disease
thought leaders continues to indicate growing support for our
program.”
“Bacteriophage therapeutics have the potential to be a safe and
potent modality for treating serious bacterial infections, and also
provide an option for those with antibiotic resistant or relapsing
infection. Encouraging initial results make it important to proceed
to full clinical evaluation and further development of this
therapeutic approach,” said Dr. Jonathan Iredell, Director of
Infectious Diseases at the Westmead Hospital in Sydney and
Professor of Medicine and Microbiology at the University of Sydney
and Westmead Institute of Medical Research.
“The treatment with bacteriophages of severely ill patients with
antibiotic-resistant infections warrants further clinical
investigation and holds promise as a new approach to this critical
unmet medical need,” said Robert T. Schooley, M.D., Professor in
the infectious disease division at the University of California,
San Diego. “The FDA also recognizes that multi-drug resistant
infections are a real problem and I believe they see this approach
as one that clearly needs to be evaluated.”
“Bacteriophage therapies have been around for the past hundred
years,” said Igor P. Bilinsky, Ph.D., COO of AmpliPhi. “It is only
now, enabled by advances in biologics manufacturing and DNA
sequencing, that we are able to produce GMP grade phage products
that could be suitable for intravenous administration. This is an
important step for developing phages as a novel, precisely targeted
therapeutic modality for patients with serious infections who have
few or no other treatment options and for helping humanity solve
the growing crisis of antibiotic resistance.”
Expanded Access Program Design and Topline Results
The expanded access approach allows critically ill patients to
receive experimental, unapproved therapies in an attempt to save
lives. Severely ill patients can receive treatment in the U.S.
under an emergency IND and in Australia under the Special Access
Scheme. AmpliPhi’s lead product candidates, AB-SA01, for
Staphylococcus aureus infections, and AB-PA01, for Pseudomonas
aeruginosa infections, are being provided through this program.
Among the first seven patients treated, four patients received
intravenous AB-SA01 and three received AB-PA01 administered
intravenously and in some cases as an inhaled therapy.
Bacteriophage treatment was administered along with the treating
physician’s choice of best available antibiotic therapy. Treated
patients suffered from bacteremia, endocarditis and lung
infections, and both investigational products were well tolerated
in all patients with no treatment-related serious adverse events
reported.
Treatment success, defined as complete resolution or significant
improvement of baseline signs and symptoms, was reported in six out
of seven patients (86%) by physician’s assessment. One patient was
determined to be a treatment failure due to death, which occurred
during surgery after three days of bacteriophage treatment. The
treating physician determined that the one death was unrelated to
treatment with bacteriophage therapy. The 28-day all-cause
mortality rate was 14%. No additional deaths occurred up to 90 days
following initiation of therapy, and patient follow up is
continuing. Based on the APACHE II scores (a validated critical
care scoring system predictive of mortality) of the seven patients
prior to initiation of bacteriophage therapy, the predicted
mortality rate for this patient group was 46%.
No bacterial isolates resistant to the bacteriophage
therapeutics were detected during the bacteriophage treatment
course. Additional analyses of these data are ongoing, and
presentations or publications of the detailed results are
planned.
Conference Call and Webcast
AmpliPhi will hold a conference call today beginning at 4:30
p.m. Eastern time (1:30 p.m. Pacific time) to discuss these
results. The conference call dial-in number is (866) 652-5200 for
domestic callers and (412) 317-6060 for international callers, and
the passcode is 10115452. A live webcast of the call will be
available on the Investor Relations section
of www.ampliphibio.com.
A recording of the call will be available for 48 hours beginning
approximately two hours after the completion of the call by dialing
(877) 344-7529 for domestic callers and (412) 317-0088 for
international callers. Please use passcode 10115452 to access the
recording. A webcast replay will be available on the Investor
Relations section of www.ampliphibio.com for 30 days,
beginning approximately two hours after the completion of the
call.
About AmpliPhi Biosciences
AmpliPhi Biosciences Corporation is a clinical-stage
biotechnology company focused on the development of precisely
targeted bacteriophage therapeutics for patients with serious and
life-threatening antibiotic-resistant bacterial infections.
AmpliPhi’s lead product candidates target
multidrug-resistant Staphylococcus aureus and Pseudomonas
aeruginosa, which are included on the WHO’s 2017 Priority
Pathogens List. Phage therapeutics are uniquely positioned to
address the threat of antibiotic-resistance as they can be
precisely targeted to kill select bacteria, have a differentiated
mechanism of action, can penetrate and disrupt biofilms (a common
bacterial defense mechanism against antibiotics), are potentially
synergistic with antibiotics and have been shown to restore
antibiotic sensitivity to drug-resistant bacteria. For more
information visit www.ampliphibio.com.
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: AmpliPhi’s plan to present additional results for the
seven patients dosed with AB-SA01 or AB-PA01; AmpliPhi’s plan to
dose up to an additional 20 patients with its bacteriophage
therapies during the first half of 2018; AmpliPhi’s plan to present
data from expanded access clinical cases to the FDA in mid-2018 and
potentially initiate a Phase 2 or registrational clinical trial as
early as the second half of 2018; and the potential benefits of
phage therapy and the potential use of bacteriophages to treat
bacterial infections, including infections that do not respond to
antibiotics or are associated with biofilms. 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. Among the
factors that could cause actual results to differ materially from
those indicated in these forward-looking statements are risks and
uncertainties associated with AmpliPhi’s business and financial
condition and the other risks and uncertainties described in
AmpliPhi’s Annual Report on Form 10-K for the year ended December
31, 2016, as filed with the SEC, and AmpliPhi’s subsequent filings
with the SEC. 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/20180103006076/en/
AmpliPhi BiosciencesMatthew Dansey, (858)
800-4869md@ampliphibio.comorInvestor
Relations:Westwicke PartnersRobert H. Uhl, (858)
356-5932robert.uhl@westwicke.comorMedia:Russo Partners, LLCDavid Schull or
Maggie Beller(212)
845-4271David.Schull@RussoPartnersLLC.comMaggie.Beller@RussoPartnersLLC.com
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