ANN ARBOR, Mich., Sept. 18, 2012 /PRNewswire/ -- Synthetic
Biologics, Inc. (NYSE MKT: SYN), a developer of synthetic biologics
and innovative medicines for serious diseases and unmet medical
needs, today announced that it has initiated efforts to develop a
monoclonal antibody (mAb) therapy for the treatment of
acinetobacter infections. Many strains of Acinetobacter are
multidrug-resistant and pose an increasing global threat to
hospitalized patients, wounded military personnel and those
affected by natural disasters. The Company also announced that it
has engaged Lewis (Lew) Barrett,
former Assistant Vice President, Established Products at Pfizer and
Vice President Global Business Manager, Infectious Diseases at
Wyeth Pharmaceuticals, to bring his expertise in the development,
commercialization and launch of infectious disease product
candidates to the Synthetic Biologics' team.
Acinetobacter is a difficult to treat pathogen due to its
rapid and well-established resistance to most antibiotics, making
it a multidrug-resistant pathogen[1]. In addition, as a
biofilm-forming pathogen, Acinetobacter has the ability to
survive up to twice as long as non-biofilm-forming pathogens[2]. In
the U.S., Acinetobacter has been reported to be the cause of
up to 2.6% of hospital acquired infections, 1.3% of bloodstream
infections and 7% of ICU respiratory tract infections[3], and more
than half of the Acinetobacter isolates are
multidrug-resistant[4]. Patients with infections caused by
Acinetobacter have been reported having mortality rates
ranging from 7.8% to 43% in the hospital and in the ICU[5]. While
Acinetobacter is a well-documented pathogen in the hospital
setting, this pathogen also poses an increasing danger to wounded
servicemen and women in military treatment centers[6] and to those
treated in trauma centers following natural disasters[7].
The initiation of mAb development for the treatment of
acinetobacter infection is the first of the three initial targeted
infectious diseases the Company intends to pursue as part of its
most recent collaboration with Intrexon Corporation. In
August 2012, Synthetic Biologics
entered into a worldwide exclusive channel collaboration with
Intrexon Corporation for the development and commercialization of
mAb therapies to treat certain infectious diseases not adequately
addressed by existing therapies. Under this collaboration, the
Company intends to utilize Intrexon's comprehensive suite of
proprietary technologies, including the mAbLogix™ and LEAP™
platforms, to develop fully human mAbs to specifically and rapidly
neutralize/clear acinetobacter pathogens. The collaboration may
optionally be expanded to include up to an additional five
infectious disease indications.
"We are pleased to begin work on a mAb therapy to treat
acinetobacter infections. Acinetobacter has developed an
increased resistance to antibiotics and other drugs over time, and
a new therapeutic option is needed to treat infectious diseases
caused by this bacteria," said Jeffrey
Riley, Chief Executive Officer of Synthetic Biologics, Inc.
"Our collaboration with Intrexon provides access to
state-of-the-art platforms that have tremendous potential to
produce a broad spectrum of fully human antibodies to fight against
Acinetobacter where other options have failed."
Mr. Riley concluded, "We welcome Lew
Barrett to our team and look forward to benefiting from his
many years of experience around the development and
commercialization of anti-infectives, as we develop mAbs for the
treatment of acinetobacter infections. We also look forward to
disclosing additional infectious disease indications we intend to
pursue in the near future."
During his 25-year career at Wyeth (acquired by Pfizer in 2009),
Mr. Barrett successfully led, co-chaired or served as the senior
marketing executive on teams that focused on infectious diseases,
oncology, transplantation, and hemophilia. He brings to Synthetic
Biologics his expertise in U.S. and global strategy,
domestic/global branding, clinical development, medical affairs,
supply chain, business development and strategic alliance
management. He built the brand and led global commercialization
efforts for Wyeth's in-line IV antibiotic, Zosyn®/Tazocin® (the
second IV antibiotic to achieve $1 billion+ in sales), and managed
the U.S. launch of Wyeth's broad-spectrum IV antibiotic, Tygacil®.
In 2010, Mr. Barrett formed LL Barrett Biopharmaceutical
Consulting, LLC, and utilizing his depth of experience in the
anti-infective, hospital and biopharma fields, provides strategic
consultation to the global life sciences field with a particular
focus on brand strategy, lifecycle strategy, business development,
and strategic communications.
"Acinetobacter has consistently demonstrated its ability
to rapidly develop resistance to antibiotics. We believe the threat
of this pathogen coupled with a scarcity of new antibiotics creates
a perfect storm. Novel biologic therapies such as Synthetic
Biologics' mAbs, with new targets and mechanisms, are especially
exciting," stated Mr. Barrett. "I look forward to working with the
Company as they work toward developing new therapeutic candidates
for a field of medicine where the availability of effective
interventions has declined."
About Monoclonal Antibodies (mAbs)
Acting as the body's army, antibodies are proteins, generally
found in the bloodstream, that provide immunity in detecting and
destroying pathogens, such as viruses and bacteria and their
associated toxins. MAbs can also be designed and produced as
therapeutic agents, utilizing protein engineering and recombinant
production technologies. The mAbs being developed under the
Synthetic Biologics' collaboration with Intrexon are intended to
supplement a patient's own immune system by providing the means to
specifically and rapidly neutralize and/or clear specific pathogens
and toxins of interest in a process known as "passive immunity".
Many pathogens that cause infectious diseases are innately
resistant to, or over time have developed increased resistance to,
antibiotics and other drugs. Synthetic Biologics intends to utilize
Intrexon's comprehensive suite of proprietary mAb design and
recombinant protein production technologies to efficiently create
potent candidate mAbs for human testing and use to specifically
treat certain infectious diseases for which current therapies are
unavailable or inadequate.
About Synthetic Biologics, Inc.
Synthetic Biologics is a biotechnology company focused on the
development of product candidates to address serious diseases and
unmet medical needs. Synthetic Biologics is developing the
following synthetic biologic candidates: a series of monoclonal
antibodies (mAbs) for the treatment of serious infectious diseases
not adequately addressed by existing therapies and a synthetic
DNA-based therapy for the treatment of pulmonary arterial
hypertension (PAH). The Company is also developing drug candidates
for the treatment of relapsing-remitting multiple sclerosis (MS),
cognitive dysfunction in MS, amyotrophic lateral sclerosis (ALS)
and fibromyalgia (partnered with Meda AB). For more information,
please visit Synthetic Biologics' website at
www.syntheticbiologics.com.
mAbLogix™ and LEAP™ are registered trademarks of Intrexon
Corporation.
Zosyn®, Tazocin® and Tygacil® are registered trademarks of
Pfizer or its affiliates.
This release includes forward-looking statements on Synthetic
Biologics' current expectations and projections about future
events. In some cases forward-looking statements can be identified
by terminology such as "may," "should," "potential," "continue,"
"expects," "anticipates," "intends," "plans," "believes,"
"estimates," and similar expressions. These statements are based
upon current beliefs, expectations and assumptions and are subject
to a number of risks and uncertainties, many of which are difficult
to predict and include statements regarding Synthetic Biologics'
intent to develop and commercialize multiclonal antibody therapies
for infectious diseases, its use of Intrexon's technologies, the
opportunity presented by Acinetobacter's ability to resist
antibiotic therapy and the expected contributions of Lewis Barrett. The forward-looking statements
are subject to risks and uncertainties that could cause actual
results to differ materially from those set forth or implied by any
forward-looking statements. Important factors that could cause
actual results to differ materially from those reflected in
Synthetic Biologics' forward-looking statements include, among
others, a failure of Synthetic Biologics' monoclonal antibodies for
the treatment of infectious diseases to be successfully developed
or commercialized, a failure of the Intrexon's intellectual
property to create potent candidate mAbs, an inability to obtain
regulatory approval of the infectious disease product candidates, a
failure of the results of clinical trials to support the efficacy
or safety of product candidates, a failure to successfully
integrate newly engaged team members, a failure of the preclinical
or clinical trials to proceed on schedules that are consistent with
Synthetic Biologics' current expectations or at all, Synthetic
Biologics' inability to protect its intellectual property and
freedom to operate without interference of the patents of others,
inability to maintain the effectiveness of the exclusive
collaboration agreement, its reliance on third parties to develop
its product candidates, the insufficiency of existing capital
reserves to fund continued operations for a particular amount of
time and uncertainties regarding Synthetic Biologics' ability to
obtain additional financing to support its operations thereafter
and other factors described in Synthetic Biologics' report on Form
10-K/A for the year ended December 31,
2011 and any other filings with the SEC. The information in
this release is provided only as of the date of this release, and
Synthetic Biologics undertakes no obligation to update any
forward-looking statements contained in this release on account of
new information, future events, or otherwise, except as required by
law.
[1] Roca, I, Espinal, P, Vila-Farres, X, and Vila, J. The Acinetobacter baumannii
oxymoron: commensal hospital dweller turned pan-resistane menace.
Frontiers in Microbiology, April
2012, Vol. 3, Article 148.
[2] Espinal P, Martí S, Vila J. Effect of biofilm formation on
the survival of Acinetobacter baumannii on dry surfaces. J
Hosp Infect. 2012 Jan; 80(1):56-60. Epub 2011 Oct 4.
[3] Jones, M, et al. Emerging
resistance among bacterial pathogens in the intensive care unit – a
European and North American Surveillance study (2000-2002). Ann
Clin Microbiol Antimicrob. 3(14).; Wisplinghoff, H, et al.
Nosocomial Bloodstream Infections in US Hospitals: Analysis of
24,179 Cases from a Prospective Nationwide Surveillance Study. Clin
Infect Dis. 2004; 39(3): 309-17.; Wachter, K. Step Aside, MRSA,
Here Comes Acinetobacter. OB. GYN. News, January 15, 2006.
[4] The Center for Disease Dynamics, Economics & Policy.
http://cddep.org/ResistanceMap/overview. Trends by U.S. Census
Divisions for Multidrug-resistant Acinetobacter baumannii
(2010).
[5] Falagas, ME, Bliziotis, LA, and Siempos, II. Attributable
mortality of Acinetobacter baumannii infections in
critically ill patients: a systematic review of matched cohort and
case-control studies. Critical Care 2006, 10:R48.
[6] Camp, C and Tatum, OL. A Review of Acinetobacter
baumannii as a Highly Successful Pathogen in Times of
War. LABMEDICINE. November
2010, Vol. 41, Number 11.
[7] Camp, C and Tatum, OL. A Review of Acinetobacter
baumannii as a Highly Successful Pathogen in Times of War.
LABMEDICINE. November 2010, Vol. 41,
Number 11.
SOURCE Synthetic Biologics, Inc.