ANNAPOLIS, Md., Oct. 27 /PRNewswire-FirstCall/ -- PharmAthene, Inc.
(NYSE ALTERNEXT US: PIP), a biodefense company developing medical
countermeasures against biological and chemical threats, today announced
that dosing of volunteers has begun in a U.S. Phase I clinical trial
evaluating Protexia(R) for safety and tolerability in humans. Protexia(R),
which is produced in the milk of transgenic goats, is a recombinant version
of human butyrylcholinesterase (BChE), which has been shown to be effective
in animal models in preventing toxicity from exposure to chemical nerve
agents.
The randomized, placebo-controlled, third-party double-blind, dose
escalating Phase I clinical trial will study Protexia(R) administered
intramuscularly at one and two time points in healthy human volunteers.
Approximately 32 subjects will participate in the study, comprised of
healthy male and female volunteers between the ages of 18 and 55 years who
are willing to give informed consent and are in general good health.
Under the study protocol, either Protexia(R) or a saline control will
be administered in escalating doses to five groups of volunteers. Safety
data through 14 days post-dosing will be evaluated prior to escalation to a
higher dose. Subjects in four of the groups (comprised of six subjects
each) will receive a single dose of Protexia(R) and participate in the
trial for two and a half months. One group of eight subjects will receive a
second dose of Protexia(R) approximately 72 days following the first dose
and will participate in the study for approximately five months.
The primary endpoint of the study is an evaluation of the safety,
tolerability, pharmacokinetics and immunogenicity of escalating single
doses of Protexia(R) given intramuscularly in healthy human volunteers. The
secondary endpoint will evaluate the safety, tolerability, pharmacokinetics
and immunogenicity of a second dose of Protexia(R) in one dose cohort.
"The initiation of patient enrollment in the Phase I study for
Protexia(R) is a significant milestone for PharmAthene as it represents
continued progress in the development of this important product candidate.
The development of Protexia(R) is currently being funded by a significant
advanced development and procurement contract from the Department of
Defense, which is seeking novel recombinant bioscavengers for prophylaxis
against nerve agent poisoning," stated David P. Wright, President and Chief
Executive Officer for PharmAthene.
"Preclinical studies suggest that Protexia(R) used as a prophylactic
against nerve agents might offer important benefits over medical
countermeasures for nerve agent poisoning," continued Mr. Wright. "Studies
in animals suggest that Protexia(R) might prevent the neurological toxicity
and cognitive impairment associated with exposure to nerve agents, which
currently approved countermeasures are not able to adequately treat. In
addition, because it is not derived from human plasma, we avoid issues
associated with viral transmission. Given our proprietary manufacturing
method, which enables substantially larger production yields than what is
possible with human plasma-derived BChE, if successfully developed,
Protexia(R) could adequately fulfill U.S. military and civilian stockpile
requirements."
In September 2006 PharmAthene was awarded a multi-year contract valued
at up to $219 million from the Department of Defense (DoD) U.S. Army Space
and Missile Command, for advanced development of Protexia(R). Under the
contract, PharmAthene is responsible for the conduct and oversight of all
product development activities. The initial stage of development, for which
$40.5 million has been allocated, includes manufacturing process
development, preclinical safety and toxicity testing, submission of an
Investigational New Drug (IND) Application with the United States Food and
Drug Administration (FDA), and conduct of a Phase I clinical trial.
Following successful completion of the Phase I trial, the government, at
its discretion, may exercise its option to fund additional development
activities beyond the initial $40.5 million, leading to FDA licensure. The
contract also provides the DoD with the option to procure an initial 90,000
doses of Protexia(R).
About Protexia(R)
Protexia(R), which is produced in the milk of transgenic goats, is a
recombinant version of human butyrylcholinesterase (BChE), a naturally
occurring protein found in minute quantities in blood (2 mg/liter). BChE
functions as a natural bioscavenger, like a sponge, to absorb and degrade
organophosphate poisons (e.g. nerve agents) before they cause neurological
damage. Protexia(R) is being developed as a pre- and post-exposure therapy
for casualties on the battlefield or civilian victims of nerve agent
attacks. Nerve agents belong to a class of compounds known as
organophosphate (OP) agents. OP nerve agents, such as sarin gas, soman,
tabun or VX, enter the blood stream via inhalation or absorption through
the skin. The nerve agents travel in the circulatory system to the brain
and muscles causing the nerves to become over-stimulated which lead to
massive convulsions and death in severe cases.
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(R) - a fully human monoclonal antibody for the prevention and
treatment of anthrax infection
-- Protexia(R) - a novel bioscavenger for the prevention and treatment of
morbidity and mortality associated with exposure to chemical nerve
agents
-- RypVax(TM) - a recombinant dual antigen vaccine for plague
For more information about PharmAthene, please visit http://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 risk 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, 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 Forms 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, at this
point there can be no assurance that the Phase I clinical trial will meet
its end points for safety, tolerability, pharmacokinetics and
immunogenicity, or that Protexia(R) will ever be shown to be safe and
effective and approved by regulatory authorities for commercial use in
humans. Significant additional non-clinical animal studies, human clinical
trials, and manufacturing development work remain to be done under this
program. Copies of PharmAthene's public disclosure filings are available
from its investor relations department and our website under the investor
relations tab at http://www.pharmathene.com.
SOURCE PharmAthene, Inc.
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Related links:
http://www.pharmathene.com/
CONTACT:
Stacey Jurchison of PharmAthene, Inc.,
+1-410-269-2610, JurchisonS@PharmAthene.com
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