ANNAPOLIS, Md., March 6 /PRNewswire-FirstCall/ -- PharmAthene, Inc., a
biodefense company specializing in the development and commercialization of
medical countermeasures against chemical and biological threats, announced
today that it has completed the initial pharmacokinetic (PK) testing of
Protexia(R), the Company's broad spectrum chemical nerve agent prophylaxis.
The PK studies were conducted in two animal species and used the final
pegylated version of rBChE for the first time. In general, the conjugation
of proteins with polyethylene glycol (PEG) has been shown to decrease
immunogenicity, increase circulating serum half-life and increase stability
of recombinant proteins. The data from these studies confirm that the
specific PEG chosen for conjugation to rBChE will significantly improve the
half-life of the protein in vivo.
The PK studies demonstrated that Protexia(R) had a half life of
approximately four days in primates and three days in rodents when
administered by intramuscular injection. These data compare favorably with
what was predicted for the drug's PK profile in these animal species.
John Troyer, Ph.D., Senior Program Director for Protexia(R), commented,
"These results are very meaningful in that they show that Protexia(R) meets
or exceeds our target product profile for use as a chemical nerve agent
prophylaxis. The impressive half life data also confirm that the pegylation
of rBChE as part of our manufacturing process achieved the goal of
extending the half-life of the protein to one which makes it a feasible
product for use in humans."
Dr. Troyer continued, "Having successfully completed the PK studies, we
are on target to complete our toxicology studies and file the
Investigational New Drug (IND) application for Protexia(R) in the third
quarter of 2008; we expect to commence Phase I human safety testing of
Protexia(R) in the fourth quarter."
"Today's announcement highlights the intense commitment and strong
technical capability PharmAthene has continually demonstrated in our
attempts to rapidly progress our biodefense product portfolio. Since
acquiring Protexia(R), we have defined a viable manufacturing process for
commercial scale production and demonstrated proof of concept showing
protection with Protexia(R) against highly lethal doses of nerve agent
exposure," said David P. Wright, President and Chief Executive Officer.
"Our proven internal expertise in drug development, in combination with
the funding and partnership provided under our DoD contract, will
significantly enhance our ability to ensure that Protexia(R) becomes an
important part of the nation's military and civilian biodefense arsenal,"
continued Mr. Wright.
In September 2006, PharmAthene was awarded a multi-year contract from
the Department of Defense (DoD) U.S. Army Space and Missile Command valued
at up to $213 million assuming all extensions and options are exercised by
the DoD, for advanced development of the Company's broad spectrum chemical
nerve agent prophylaxis, Protexia(R). The contract includes a procurement
option by the DoD for an initial 90,000 doses of Protexia(R). The
Protexia(R) contract was awarded through a full and open competitive
solicitation seeking novel second generation prophylactic products for use
in humans to prevent and treat poisoning from organophosphorus (OP) nerve
agents such as sarin gas, soman, tabun and VX.
About Protexia(R): PEGylated Recombinant Human Butyrylcholinesterase
(rBChE)
Protexia(R) is a form of recombinant human butyrylcholinesterase
(rBChE), a potent organophosphorus (OP) scavenger protein produced in the
milk of transgenic goats, which is being developed for use as a
prophylactic against acute organophosphorus (OP) nerve agent toxicity.
About Chemical Weapons
Organophosphorus nerve agents, or anti-cholinesterase agents, were
discovered in the 1930s following intensive research into new insecticides.
Their discovery represents the beginning of modern chemical warfare. These
agents cause toxicity by binding to and inhibiting acetylcholinesterase, an
enzyme in the body that is essential for nervous system function, leading
to increases in acetylcholine and "cholinergic crisis" that can cause loss
of muscle control, respiratory failure, paralysis, convulsions, permanent
brain damage and eventually death.
These so-called nerve gases, which are actually all liquids at room
temperature, are lethal far more quickly and in far lower concentrations
than other classical chemical warfare agents such as vesicants, choking
agents and blood agents, and are effective both when inhaled and when
absorbed through the skin. Nerve agents can be classified as either
G-agents (sarin, soman, tabun) or V-agents (VX), both of which are
exceedingly toxic.
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.
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"; "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 risk associated with the reliability of the results
of the studies relating to human safety and possible adverse effects
resulting from the administration of Protexia(R), unexpected funding
delays, unforeseen safety issues, unexpected determination that Protexia(R)
proves not to be effective or capable of being marketed as a product, 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.
SOURCE PharmAthene, Inc.
 back to top
Related links:
http://www.pharmathene.com/
CONTACT:
Stacey Jurchison, Director, Corporate
Communications of PharmAthene, Inc., +1-410-269-2610, Cell:
+1-410-474-8200, JurchisonS@PharmAthene.com
|
