"We are pleased to continue to support PharmAthene as it develops
Protexia®," stated Geoffrey F. Cox, Ph.D., GTC`s Chairman and Chief
Executive Officer. "The constraint in supplying BChE from either human
plasma sources or other recombinant systems is an excellent example of
transgenic production enabling development of otherwise difficult to
express proteins."
While the utility of human plasma derived butyrylcholinesterase
(BChE) to protect against nerve agent toxicity is well documented, a
major limitation hindering its commercial development has been the
inability to produce commercial quantities due to a limited
availability of appropriate blood supplies, low levels of the protein
in plasma, and low production yields using traditional biotechnology
methods. Protexia® overcomes these limitations by enabling
substantially larger production yields than are possible using other
expression systems or through purification of the native protein from
human plasma. Transgenic production and manufacturing is estimated to
be capable of supplying sufficient rBChE to make Protexia® available
for use by the military and civilian populations.
About Nerve Agents
Organophosphate nerve agents, or anti-cholinesterase agents, cause
toxicity by binding to and inhibiting acetylcholinesterase, an enzyme
in the body that is essential for nervous system function. This leads
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 in low quantities when inhaled or 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
volatile and toxic.
About Protexia®: Recombinant Human Butyrylcholinesterase
Protexia® is a pegylated form of recombinant human
butyrylcholinesterase (rBChE), a potent organophosphate (OP) scavenger
protein produced in the milk of transgenic goats, which is being
developed for use as a prophylactic and therapeutic against acute
organophosphate (OP) nerve agent toxicity. PharmAthene`s development of
Protexia® is being funded by a multi-year contract from the Department
of Defense (DoD) U.S. Army Space and Missile Command. For more
information on PharmAthene, please visit www.PharmAthene.com.
About GTC Biotherapeutics, Inc.
GTC Biotherapeutics develops, supplies, and commercializes
therapeutic proteins produced through transgenic animal technology.
ATryn®, GTC`s recombinant human antithrombin, has been approved for use
in Europe and has begun the review process in the United States under a
rolling Biologics License Application. In addition to ATryn®, GTC is
developing a portfolio of recombinant human plasma proteins with known
therapeutic properties. These proteins include recombinant forms of
human coagulation factors VIIa, VIII, and IX, which are used for the
treatment of hemophilia, and alpha-1 antitrypsin. GTC also has a
monoclonal antibody portfolio that includes a monoclonal antibody to
CD20 and a monoclonal antibody to CD137. GTC`s intellectual property
includes a patent in the United States through 2021 for the production
of any therapeutic protein in the milk of any transgenic mammal. GTC`s
transgenic production platform is particularly well suited to enabling
cost effective development of proteins that are difficult to express in
traditional recombinant production systems as well as proteins that are
required in large volumes. Additional information is available on the
GTC web site, www.gtc-bio.com.
Forward looking statements
This press release contains forward-looking statements as defined in
the Private Securities Litigation Reform Act of 1995, including without
limitation statements regarding the potential efficacy of Protexia® for
biodefense and PharmAthene`s potential production requirements for the
development of Protexia® for the Department of Defense. Such
forward-looking statements are subject to a number of risks,
uncertainties and other factors that could cause actual results to
differ materially from future results expressed or implied by such
statements. Factors that may cause such differences include, but are
not limited to, the risks and uncertainties discussed in GTC`s most
recent Annual Report on Form 10-K and its other periodic reports filed
with the Securities and Exchange Commission, including the risks and
uncertainties associated with the development of therapeutic proteins
and dependence upon the actions of partners and regulatory and other
governmental agencies. GTC cautions investors not to place undue
reliance on the forward-looking statements contained in this release.
These statements speak only as of the date of this document, and GTC
undertakes no obligation to update or revise the statements, except as
may be required by law. GTC obtained the information in this press
release regarding Protexia, PharmAthene and its business, other than
its agreement with GTC, from PharmAthene`s published information; and
GTC has not independently verified any of such information.
Contact
GTC Biotherapeutics, Inc.
Thomas E. Newberry, 508-370-5374
Vice President, Corporate Communications
tom.newberry@gtc-bio.com
