MONTREAL, Dec. 14 /PRNewswire-FirstCall/ - Nexia Biotechnologies Inc.
(TSX:NXB) announced today that their US & Canadian military biodefense
partnerships have yielded early but promising results for the use of
Protexia(R) (recombinant human butyrylcholinesterase - BChE) to treat civilian
casualties resulting from a terrorist chemical weapon attack. The Protexia(R)
program, initiated in 2003, has been focusing on the development of medical
prophylaxis for military personnel and 1st responders working in contaminated
areas. Protexia(R) is being developed for prophylaxis by Nexia in conjunction
with military researchers at the U.S. Army Medical Research Institute of
Chemical Defense (USAMRICD) in Maryland and Defence R&D Canada-Suffield (DRDC
Suffield) in Alberta. The US Department of Defense has budgeted support for
the development of recombinant BChE. Nexia's Protexia(R) is in competition for
this funding. Today's announced results show that Protexia(R) can be effective
as a rescue treatment, thus adding a new dimension to the existing program.
Rescue therapy (post-exposure treatment) involves treating the casualties
of a terrorist chemical weapons attack. Typically victims go to the hospital
for medical assistance only after the onset of symptoms of nerve agent
toxicity. With conventional therapies, the elapsed time from chemical exposure
to start of treatment is critical. The tests conducted at USAMRICD and DRDC
Suffield simulated human nerve agent exposure with different skin types and
time delays, then tested Protexia(R)'s efficacy when administered by different
methods - intravenous (IV) or intramuscular (IM). Multiple lethal doses of the
nerve agent VX, the most lethal nerve agent known, served as the toxic
challenge. The risk of VX to humans is predominantly via skin or surface
exposure; therefore, both military organizations' teams focused their trials
on skin factors.
Experimental Results Prove Efficacy
USAMRICD administered Protexia(R) intramuscularly to guinea pigs
approximately an hour after they had been exposed to 2X or 5X lethal doses of
VX on the skin. Protexia(R) rescued 90% (9/10) of the 2X group of guinea pigs
with no lingering toxic effects noted. At the very high 5X level, 4/10 guinea
pigs were rescued by the Protexia(R) treatment. In addition, Protexia(R)
delayed the time to onset of poisoning symptoms and lessened them when
compared to the control groups. This observation is significant because it
expands the opportunity to transport casualties and thus allow enhanced
treatment outside and within a hospital setting.
DRDC Suffield administered Protexia(R) intravenously into domestic swine
that had been previously exposed to 2X lethal doses of VX on the skin. DRDC
Suffield used swine because the skin on the ears of these animals closely
mimics human skin. Nerve agent was applied topically and gained access to the
body across the skin. Protexia(R) rescued 75% (3/4) of the swine. As with the
guinea pigs above, Protexia(R) produced a significant decrease in the severity
of the signs of poisoning, as well as a delay in their onset, compared to
VX-only treated animals.
Protexia(R) Manufacturing and Clinical Batches
These multi-center trials, which required many grams of Protexia(R), were
possible because of the scaled-up manufacturing of Protexia(R) produced in the
milk of transgenic goats. This level of production is sufficient to support
all preclinical studies and cGMP process development. The clinical development
program is expected to be regulated under the U.S. FDA's Animal Efficacy Rule.
Terrorist attacks on Tokyo in 1995 documented the limitations of existing
medical countermeasures and their deployment. Today's standard of care
involves repeated doses of a cocktail of drugs including; atropine, oxime
reactivators and anticonvulsants. In the future, the use of biotech
breakthrough drugs like Protexia(R) could provide definitive care with a just
a single injection.
"Protexia(R)'s effectiveness as an antidote to nerve agent poisoning
clearly demonstrates the potential of this new class of drugs to treat victims
of terrorist chemical weapons attack", stated Dr. Thomas Sawyer, Chief
Scientist, DRDC Suffield.
"Protexia(R) rescue therapy removes nerve agents directly from the
bloodstream by breaking them down into inactive components, rather than just
treating the neurotoxic symptoms, as is the case with existing therapy,"
stated Dr. Jeffrey D. Turner, President & CEO, Nexia Biotechnologies,
"Protexia(R) clearly lessened the severity of nerve agent poisoning and
delayed the onset of toxic effects in all animal models."
Concurrent Announcement
Nexia has today also made certain announcements relating to its year end
financial results and other developments. For more information, please visit
Nexia's website at http://www.nexiabiotech.com .
About USAMRICD
The U.S. Army Medical Research Institute of Chemical Defense (USAMRICD)
develops medical countermeasures to chemical warfare agents and trains medical
personnel in the medical management of chemical casualties and is a recognized
leader in this field. Please refer to USAMRICD's web site at:
http://chemdef.apgea.army.mil .
About DRDC Suffield
DRDC Suffield is Canada's centre of expertise in chemical and biological
defence. DRDC offers timely technical advice, seminars, training and equipment
to counter hazards from the use of chemical or biological agents. Advances in
biochemical detection and identification, decontamination and medical
countermeasure research continue to see DRDC Suffield as a world-class leader
in CB research. DRDC Suffield is one of six defence research establishment of
Defence R&D Canada (DRDC). DRDC, an agency within the Department of National
Defence, has been keeping Canada in the forefront of defence and national
security technology by providing scientific leadership to the Canadian Forces
and the Canadian defence industry for more than 60 years. For more
information, visit their website at http://www.drdc-rddc.gc.ca .
About Nexia
Nexia develops and manufactures complex recombinant proteins in the milk
of transgenic goats for medical applications. Nexia's strength is producing
proteins that cannot be made commercially using other recombinant systems. The
Company's lead product is Protexia(R), which is funded by a tripartite
development consortia consisting of Nexia, and the U.S. and Canadian
militaries. Protexia(R) is being developed as a military prophylaxis and as a
post-exposure therapy for civilian casualties of domestic terrorist attacks.
Protexia(R) is recombinant human butyrylcholinesterase produced in the milk of
Nexia's transgenic dairy goats. Protexia(R)'s capability as a medical
countermeasure has been demonstrated in vivo to protect animals from multiple
lethal doses of a broad spectrum of nerve agent chemical weapons. For more
information, please visit Nexia's website at http://www.nexiabiotech.com .
Protexia is a registered trademark in Canada of Nexia Biotechnologies
Inc.
Except for the historical information presented herein, matters discussed
herein may constitute forward-looking statements 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
"believes"; "anticipates"; "intends"; "plans"; "expects"; "estimates"; or
similar statements are forward-looking statements. Such statements
reflect management's current views and are based on certain assumptions.
Actual results could differ materially from those currently anticipated
as a result of a number of factors, including risks and uncertainties
discussed in Nexia's filings with Canadian regulatory authorities. An
additional business risk associated with the Protexia(R) program relates
to the fact that large purchases are expected to be made from a few
customers. Changes in demand from these customers could significantly
affect our program. There can be no assurance that such development
efforts will succeed, that such products will receive required regulatory
clearance or that, such products would ultimately achieve commercial
success.
| |
SOURCE NEXIA BIOTECHNOLOGIES INC.
 back to top
CONTACT:
Nexia Biotechnologies Inc. Contact: Jeffrey
D. Turner, Ph.D., President and CEO, (450) 424-8920,
jturner@nexiabiotech.com; DRDC Suffield Contact: Jennifer Faust,
Communications Officer, (403) 544-4622,
Jennifer.Faust@drdc-rddc.gc.ca
| |
|
