Data Show Valortim Anthrax Anti-Toxin May Augment Immune System's Ability to Destroy Anthrax Bacteria
New Valortim(R) Data Presented at the 8th Annual ASM Biodefense and Emerging Diseases Research Meeting
ANNAPOLIS, Md., Feb. 24 /PRNewswire-FirstCall/ -- PharmAthene,
Inc. (NYSE Amex: PIP), a biodefense company developing medical
countermeasures against biological and chemical threats, announced
today that new data from the Company's Valortim® anthrax
anti-toxin program were presented at the 8th Annual ASM Biodefense
and Emerging Diseases Research Meeting, held in Baltimore,
Maryland, February 21-24, 2010.
The data were presented by Dr. Alan S. Cross, Professor of
Medicine and Dr. Subhendu Basu, Assistant Professor, University of
Maryland School of Medicine, in a poster presentation entitled
Human Adaptive Immune Response to Bacillus Anthracis.
Valortim® is a fully human anti-toxin monoclonal antibody
being developed for the prevention and treatment of inhalational
anthrax. Preclinical studies suggest that Valortim® has the
potential to provide protection against anthrax infection when
administered prophylactically (prior to the emergence of symptoms
of anthrax infection) and also may increase survival when
administered therapeutically (once symptoms become evident).
Previous data presented by Drs. Cross and Basu have shown that
in addition to inhibiting anthrax toxin, Valortim® appears to
augment the immune system's ability to kill anthrax bacilli by
enhancing the human dendritic cell response to a challenge with
anthrax spores. These new data expand upon these observations by
showing that Valortim® also enhances the human T cell response
to B. anthracis. In addition to Valortim's established
toxin-neutralizing function, which has been previously described,
these studies indicate that it may also assist in enhancing the
adaptive immune response to anthrax, which may lead to a reduction
and clearance of the bacteria in the host organism.
Dr. Cross remarked, "Our latest research using human immune
cells provides additional evidence of the role Valortim® may
play in enhancing the elimination of B. anthracis to potentially
minimize the severity of infection. We hypothesize that
Valortim® may protect against lethal anthrax infection by its
toxin neutralization activity that allows the development of a
potent adaptive immune response that facilitates the elimination of
harmful bacteria in a host organism."
David P. Wright, President and Chief Executive Officer of
PharmAthene, commented, "Drs. Cross and Basu continue to make
excellent progress demonstrating how Valortim® may interact
with the immune system to potentially minimize the extent and
severity of infection with bacillus anthracis. These data, combined
with the accumulating non-clinical efficacy results in animal
models, continue to show how Valortim® may have important
differentiating benefits, which, if confirmed, may make it a strong
choice for procurement consideration in the Strategic National
Stockpile."
The work reported by Drs. Cross and Basu is supported by the
Maryland Industrial Partnerships Program (MIPS). The MIPS program
was developed to accelerate the commercialization of technology in
Maryland by jointly funding collaborative R&D projects between
companies and University System of Maryland faculty.
About Valortim®
Valortim® is a fully human monoclonal antibody designed to
protect against and treat anthrax infection, including inhalational
anthrax, the most lethal form of illness in humans caused by the
Bacillus anthracis bacterium. The investigational antibody is
designed to target a protein component known as the anthrax
Protective Antigen (PA) of the lethal toxin complex produced by the
bacterium. Preclinical studies suggest that Valortim® has the
potential to provide significant protection against anthrax
infection when administered prophylactically post-exposure (i.e.,
prior to the emergence of symptoms of anthrax infection) and also
may increase survival when administered therapeutically (i.e., once
symptoms become evident).
Anti-toxins such as Valortim® are a key element in combating
and treating anthrax infection, in addition to vaccines and
antibiotics. The Department of Health and Human Services has issued
a requirement for up to 200,000 anthrax anti-toxin treatments to be
included in the Strategic National Stockpile and PharmAthene
believes that Valortim® is well positioned to address this
need.
About Anthrax
According to the Centers for Disease Control and Prevention,
anthrax is an acute infectious disease caused by the spore-forming
bacterium Bacillus anthracis. Anthrax most commonly occurs in
hoofed mammals and can also infect humans. Symptoms of disease vary
depending on how the disease is contracted, but usually occur
within seven days after exposure. The serious forms of human
anthrax are inhalation anthrax, cutaneous anthrax, and intestinal
anthrax. Initial symptoms of inhalation anthrax infection may
resemble a common cold. After several days, the symptoms may
progress to severe breathing problems and shock. Inhalation anthrax
is often fatal, even if treated by antibiotics. Currently,
antibiotics are the only drugs available for therapeutic or
prophylactic use for inhalation anthrax, and post-exposure
prophylaxis is the only FDA-approved indication for such products.
However, antibiotic therapy, while useful, is believed to be
associated with a number of limitations, including: (1) lack of
activity against the toxins produced by the B. anthracis bacteria,
(2) need for long-term dosing to achieve full protection,
complicated by side effects and non-compliance (3) lack of efficacy
when administered late in the anthrax disease cycle, and (4) lack
of effectiveness against multi-drug resistant or genetically
engineered strains of anthrax.
About PharmAthene, Inc.
PharmAthene was formed to meet the critical needs of the United
States and its allies by developing and commercializing medical
countermeasures against biological and chemical weapons.
PharmAthene's lead product development programs include:
-- SparVax(TM) - a second generation recombinant protective antigen (rPA)
anthrax vaccine
-- Third generation rPA anthrax vaccine
-- Valortim® - a fully human monoclonal antibody for the prevention and
treatment of anthrax infection
-- Protexia® - a novel bioscavenger for the prevention and treatment of
morbidity and mortality associated with exposure to chemical nerve
agents
For more information about PharmAthene, please visit www.PharmAthene.com.
Statement on Cautionary Factors
Except for the historical information presented herein, matters
discussed may constitute forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
that are subject to certain risks and uncertainties that could
cause actual results to differ materially from any future results,
performance or achievements expressed or implied by such
statements. Statements that are not historical facts, including
statements preceded by, followed by, or that include the words
"potential"; "believe"; "anticipate"; "intend"; "plan"; "expect";
"estimate"; "could"; "may"; "should"; or similar statements are
forward-looking statements. PharmAthene disclaims, however, any
intent or obligation to update these forward-looking statements.
Risks and uncertainties include risks associated with the
reliability of the results of the studies relating to human safety
and possible adverse effects resulting from the administration of
the Company's product candidates, unexpected funding delays and/or
reductions or elimination of U.S. government funding for one or
more of the Company's development programs, the award of government
contracts to our competitors, unforeseen safety issues, challenges
related to the development, scale-up, and/or process validation of
manufacturing processes for our product candidates, unexpected
determinations that these product candidates prove not to be
effective and/or capable of being marketed as products, as well as
risks detailed from time to time in PharmAthene's Form 10-K and
10-Q under the caption "Risk Factors" and in its other reports
filed with the U.S. Securities and Exchange Commission (the "SEC").
In particular, significant additional non-clinical animal studies,
human clinical trials, and manufacturing development work remain to
be completed for Valortim®. At this point there can be no
assurance that Valortim® will be shown to be safe and effective
and approved by regulatory authorities for use in humans. Copies of
PharmAthene's public disclosure filings are available from its
investor relations department and our website under the investor
relations tab at www.PharmAthene.com.
Source: PharmAthene, Inc.
CONTACT: Stacey Jurchison of PharmAthene, Inc.,
+1-410-269-2610,
Stacey.Jurchison@PharmAthene.com
Web Site: http://www.pharmathene.com/
Posted: February 2010
