ANNAPOLIS, Md. and PRINCETON, N.J., Nov. 6 /PRNewswire-FirstCall/ --
PharmAthene, Inc. (Amex: PIP), a biodefense company developing medical
countermeasures against biological and chemical threats, and Medarex, Inc.
(Nasdaq: MEDX), a leading monoclonal antibody company, today announced that
the FY 2008 Department of Defense (DoD) appropriations bill includes $0.8
million payable to PharmAthene on a cost reimbursement basis to support
ongoing development of Valortim(TM), a fully human monoclonal antibody
generated by Medarex's UltiMAb(R) technology that is being co-developed by
the two companies. This is the third consecutive year in which PharmAthene
has received appropriations funding for Valortim.
"The latest DoD appropriations funding will be used to support further
study of Valortim in a promising new animal model of anthrax infection,"
commented Matthew G. Meldorf, M.D., Senior Program Director for Valortim at
PharmAthene. The new model, which is being developed at the United States
Army Medical Research Institute of Infectious Diseases (USAMRIID), seeks to
improve on existing therapeutic models for anthrax by closely monitoring
the disease process to establish the presence of anthrax bacteremia and to
determine the optimal window for therapeutic intervention.
"It is currently very difficult to evaluate the therapeutic effect of
new treatments because the mortality rate is very high and the time-course
from anthrax exposure to death is quite rapid in existing anthrax models,"
said Dr. Meldorf. "The newly-developed USAMRIID model uses a rapidly
detectable surrogate marker for the development of symptomatic anthrax
disease. This will enable us to more accurately determine the therapeutic
efficacy of Valortim in animals who have active disease defined in this
way."
"Six years after the anthrax attacks of 2001, we believe that the
development of effective therapies to prevent and treat anthrax infection
is still a critical national security priority," said David P. Wright,
President and Chief Executive Officer of PharmAthene. "Based on the
promising preclinical and clinical data generated to date, we strongly
believe that Valortim(TM) may be an appropriate choice for procurement in
the Strategic National Stockpile under Project BioShield."
"We are pleased with the ongoing success of our colleagues at
PharmAthene in securing external funding to support the advanced
development of Valortim and believe that the new animal model under
development at USAMRIID will help assess the therapeutic potency of this
antibody," said Israel Lowy, M.D., Ph.D., Senior Director of Infectious
Disease for Medarex. "Through our research we have identified important
characteristics of Valortim, such as its mechanism of action,
pharmacokinetics, animal efficacy, and favorable human safety data. We
believe that these attributes will play a key role in the further
development of Valortim and potential government procurement."
About Valortim
Valortim (MDX-1303) is a fully human antibody designed to protect
against anthrax infection, including inhalation 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. The anthrax protective antigen is believed to initiate the
onset of the illness by attaching to cells in the infected person, and then
is believed to facilitate the entry of additional destructive toxins into
the cells. Valortim is designed to target anthrax protective antigen and
protect the cells from damage by the anthrax toxins.
Valortim has been administered intravenously and intramuscularly to 46
healthy human volunteers in a completed phase I study, was well tolerated
at doses as high as 20 mg/kg (IV), and was not immunogenic. The Phase I
data showed that Valortim was safe and well-tolerated. No drug-related
Grade 2-4 or serious adverse events were reported. Grade 1 adverse events
were reported in 16 of the volunteers overall, with the most common being
pain/burning at the injection site for those being dosed intramuscularly (6
subjects). There were also a few mild headaches (3 subjects overall).
Pharmacokinetic analysis suggested that doses as low as 1 mg/kg resulted in
circulating levels of antibody after a month, with a similar potency for
neutralizing anthrax toxin in vitro as was seen with serum obtained from
subjects who had been vaccinated with anthrax vaccine. These study results
were presented at the 2006 Annual Meeting of the Infectious Diseases
Society of America.
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 the
potential to be administered therapeutically (once symptoms become
evident).
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, 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 (Amex: PIP) 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
programs include Valortim(TM) for the prevention and treatment of anthrax
infection and Protexia(R) for the prevention and treatment of morbidity and
mortality associated with exposure to chemical nerve agents. For more
information on PharmAthene, please visit http://www.PharmAthene.com.
About Medarex, Inc.
Medarex is a biopharmaceutical company focused on the discovery,
development and potential commercialization of fully human antibody-based
therapeutics to treat life-threatening and debilitating diseases, including
cancer, inflammation, autoimmune disorders and infectious diseases. Medarex
applies its UltiMAb(R) technology and product development and clinical
manufacturing experience to generate, support and potentially commercialize
a broad range of fully human antibody product candidates for itself and its
partners. More than 30 of these therapeutic product candidates derived from
Medarex technology are in human clinical testing or have had INDs submitted
for such trials, with seven of the most advanced product candidates
currently in Phase III clinical trials. Medarex is committed to building
value by developing a diverse pipeline of antibody products to address the
world's unmet healthcare needs. For more information about Medarex, visit
its website at http://www.medarex.com.
About USAMRIID
USAMRIID, located at Fort Detrick, Maryland, is the lead medical
research laboratory for the U.S. Biological Defense Research Program, and
plays a key role in national defense and in infectious disease research.
The Institute's mission is to conduct basic and applied research on
biological threats resulting in medical solutions (such as vaccines, drugs
and diagnostics) to protect the war fighter. USAMRIID is a subordinate
laboratory of the U.S. Army Medical Research and Materiel Command.
The information contained in this press release does not necessarily
reflect the position or the policy of the United States government and no
official endorsement should be inferred.
Statement on Cautionary Factors
For PharmAthene: 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"; "may"; "should"; "could"; 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 Valortim in humans, timely and
successful development of an efficient and scalable manufacturing process,
unexpected funding delays by NIAID/BARDA, unforeseen safety issues
resulting from the handling of Bacillus anthracis, as well as risks
detailed from time to time in PharmAthene's public disclosure filings with
the U.S. Securities and Exchange Commission (the "SEC"). There can be no
assurance that such development efforts will succeed or that other
developed products will receive required regulatory clearance or that, even
if such regulatory clearance were received, such products would ultimately
achieve commercial success. Copies of PharmAthene's public disclosure
filings are available from its investor relations department.
For Medarex: Except for the historical information presented herein,
matters discussed herein 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"; "suggest"; "may"; "should";
"could"; or similar statements are forward-looking statements. Medarex
disclaims, however, any intent or obligation to update these
forward-looking statements, except as required by law. Risks and
uncertainties include risks associated with the reliability of the results
of the initial work conducted on Valortim relating to animal efficacy,
human safety and likelihood of successful development of an efficient and
scalable manufacturing process, unexpected funding delays by NIAID/BARDA,
unforeseen safety issues resulting from the handling of Bacillus anthracis,
unforeseen safety issues resulting from the administration of Valortim(TM)
(MDX-1303) in human subjects, uncertainties related to product
manufacturing as well as risks detailed from time to time in Medarex's
public disclosure filings with the U.S. Securities and Exchange Commission
(SEC), including its Annual Report on Form 10-K for the fiscal year ended
December 31, 2006 and its quarterly reports on Form 10-Q. There can be no
assurance that such development efforts will succeed or that other
developed products will receive required regulatory clearance or that, even
if such regulatory clearance were received, such products would ultimately
achieve commercial success. Copies of Medarex's public disclosure filings
are available from its investor relations department.
Medarex(R), the Medarex logo and UltiMAb(R) are registered trademarks
of Medarex, Inc. All rights are reserved. "Valortim(TM) is a trademark of
PharmAthene, Inc. All rights are reserved."
SOURCE PharmAthene, Inc.
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Related links:
http://www.pharmathene.com
http://www.medarex.com
CONTACT:
Stacey Jurchison, Director, Corporate
Communications, of PharmAthene, Inc., +1-410-269-2610,
jurchisons@pharmathene.com; or Laura S. Choi, Investor Relations,
+1-609-430-2880, x2216, or Jean Mantuano, Corporate
Communications (media), +1-609-430-2880, x2221, both of Medarex,
Inc.
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