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Anthrax
Ab
Nanopharma
is conducting preclinical studies to
test the safety of a novel antibiotic against Anthrax, a disease
caused by the bacterium Bacillus
anthracis. Our immediate goal is to
develop an injectable form for pre- and
post-exposure treatment of inhalation
anthrax, the most dangerous and lethal
form of the bacterium.
Anthrax
Overview
of the disease
Bacillus anthracis is a
spore-forming bacterium which can enter
the human body through the intestine
(ingestion), lungs (inhalation), or skin
(cutaneous). Even though anthrax is
non-contagious and is unlikely to spread
from person to person, humans can become
infected by handling or ingesting
infected animal products (e.g. uncooked
meat) or by breathing-in anthrax spores
from infected animal products (like
wool, for example). Most importantly,
however, anthrax received significant
media attention in the United States
following the events of September 11,
2001 and is classified as a Category A
Bioterrorism agent.
Anthrax bacteria produce
spores that can be easily processed to
be aerosolized and sent via regular mail
through the US Postal Service. Anthrax
spores can be spread by missiles,
artillery, aerial bombs and sprayers and
can be produced in large quantities with
relatively basic technology. Any country
or terrorist organization with basic
healthcare or basic pharmaceutical
industries has the capabilities to use
anthrax as a bioterrorism agent.
The
U.S. government does not yet have the
necessary countermeasures needed to
protect its people from bio-weapons such
as anthrax. The threat posed by anthrax
and similar biohazards is especially
true today as genetic engineering is
becoming more and more common throughout
the world. New pathogens can be created
more easily and cheaply than ever
before, including “superbugs” highly
resistant to conventional drugs. Methods
to create antibiotic-resistant strains
of anthrax have already been developed
and widely available to the general
public. In conclusion, there is a
timely and critical need for an alternative
cure for Anthrax, either as
stand-alone agent or as an adjunct to
current antibiotics and vaccines.
Current
therapies
The only vaccine approved
in the U.S. is Biothrax® (formerly known
as Anthrax Vaccine Adsorbed-AVA).
Although vaccines can provide long term
protection against anthrax, vaccination
is effective only if administered well
before a person is infected by the
bacterium. Immunization through Biothrax®
consists of three injections given two
weeks apart, followed by three
additional injections at 6, 12 and 18
months. Currently, newer and improved
vaccines are being developed, but
vaccines alone are not useful if a
person is already infected by the
disease.
Antibiotics,
on the other hand, can be used to treat
people in the early stages of infection
and/or as a prophylactic therapy. For
B. anthracis, ciprofloxacin,
doxycycline and penicillin G remain the
drugs of choice.
Unfortunately, existing
antibiotics are increasingly unable to
keep pace with drug-resistant bacterial
infections. Bacterial resistance to
fluoroquinolones (e.g. ciprofloxacin)
has already emerged in E. coli
and other Enterobacteriaceae. Similarly,
bacterial resistance to tetracyclines
(e.g. doxycyline) is known, especially
among gram positive cocci.
Finally, anthrax strains resistant to
penicillin have already been developed
and therefore the potential for
multi-drug resistant strains of anthrax
is a real concern.
Presently, a handful of
companies are pursuing non-antibiotic
based strategies against anthrax, mostly
based upon polyclonal and monoclonal antibody (MAb)
technologies using either mouse
antibodies, chimeric or humanized
antibodies. The
Department
of Health and Human Services (HHS)
already announced the purchase of some
of these drug therapies from the private
sector. Although initial clinical
results are promising, these
technologies can be very costly and
resource extensive, factors which may
severely limit mass-scale production of
newer drugs against anthrax.
Our technology
In order to meet the
strong demand and need for an alternative
treatment for Anthrax, Nanopharma
Technologies is developing a new class of
synthetic antibiotics (N-thiolated
beta-lactams) with demonstrated bacteriostatic properties against B.
anthracis. These compounds can be
prepared quickly and without expensive
equipment or elaborate molecular biology
techniques, as opposed to many therapies
currently under development.
Furthermore, the distinctly unique
mechanism of action of these compounds suggests that it would be
extremely difficult to engineer strains
of anthrax resistant to this antibiotic.
Drug-resistant bacteria such as Staph. aureus, Streptococcus and N. gonorrheae
are very responsive to the
anti-microbial properties of the N-thiolated
lactams, in spite of their resistance to
penicillin and vancomycin. Bacterial resistance against the lactams
would be extremely difficult and would
require a considerable investment of
cellular resources and/or genetic
engineering.
Development
plan
Nanopharma
has a well-defined research and
preclinical development
program for its Anthrax antibiotic.
The development plan integrates our
basic science and preclinical research capabilities with the
expertise of contract
manufacturers and service providers in
order to scale up production as quickly as possible.
The
company has
held meetings with the U.S. FDA and
other service contractors like Battelle
Laboratories to guarantee progress and solicit
guidance in the development of
this product.
We are proud of taking a proactive role
in this area of national security. Our open dialogue with federal
agencies, consultants and contractors
will continue until we succeed in our
endeavors. |
