Nexia Biotechnologies Inc. - Successful Completion of "Pharmacokinetics" Milestone Triggers Protexia(TM) Drug Development for Civilian and Military Indications
Tuesday April 13, 8:01 am ET
MONTREAL, April 13 /CNW Telbec/ - Nexia Biotechnologies Inc. (TSX:NXB - News) today announced the successful completion of the pharmacokinetic (PK) studies for Protexia(TM) - the final pre-development milestone. These studies, conducted by the US Army`s Institute for Chemical Defense and Defence R&D Canada-Suffield, confirmed an appropriate PK profile for Protexia(TM) in experimental animal models. The technical results will be presented at the Medical Defense "Biosciences Review" Conference on May 16, 2004. Completion of this milestone triggers the Protexia(TM) drug development program including; transgenic herd scale-up, Good Manufacturing Practises (GMP) purification process development and completion of the pre-clinical studies to support the filing of an Investigational New Drug Exemption (IND) with the US FDA.
Since the sarin nerve gas attack in the Tokyo subway system in 1995, the vulnerability of North American and European cities to chemical weapons is clear. Following 9/11, the US government has mounted an intensive anti-terrorism campaign and has allocated unprecedented financial resources to develop technologies and products to address these threats. Given the urgent civilian requirement and Protexia(TM)`s demonstrated effectiveness as a countermeasure for chemical weapons, Nexia will be expanding its Protexia(TM) drug development program to add the civilian post-exposure therapy (treatment) indication, which is a significantly larger market than its existing military battlefield prophylaxis indication.
Protexia(TM) Program Update
Under the Protexia(TM) development plan announced in November 2003, three key milestones were expected to be completed within 12 months:
- The first milestone was to demonstrate in vitro binding and
neutralization by Protexia(TM) of a variety of nerve agents, including
soman, sarin, VX and tabun. This was successfully achieved on
November 20, 2003.
- The second was to perform in vivo challenge studies with nerve agents
to demonstrate that Protexia(TM) is efficacious as a protective agent
in animal models. This was successfully achieved on January 22, 2004.
- The third milestone (pharmacokinetics) showed that a single injection
of Protexia(TM) resulted in a sustained elevation of blood BChE levels
for many hours. Regarding distribution of Protexia(TM) within the
body, the PK data shows that Protexia(TM) concentrates in the blood
stream. Retention in the blood is critical because it is here that
Protexia(TM) bioscavenges nerve agents that principally gain access to
the body`s nervous system via the blood.
"By leveraging military R&D and funding results, Nexia has completed these 3 milestones earlier than anticipated. We are now focussed on Protexia(TM) drug development for both military prophylaxis and civilian post-exposure therapies. The Strategic National Stockpile requires drugs like Protexia(TM) for rapid deployment during a domestic chemical weapon attack." stated Dr. Jeffrey D. Turner, President & CEO, 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 two lead programs are Protexia(TM) and BioSteel(R). Protexia(TM) is being developed as a military prophylaxis and as a post-exposure therapy for civilian casualties of domestic terrorist attacks. BioSteel(R), a recombinant spider silk, is under development for use in medical devices. For more information, please visit Nexia`s website at www.nexiabiotech.com .
The United States Army Medical Research and Material Command (USAMRMC) 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/ .
Defence Research and Development Canada (DRDC) Suffield is the Canadian Centre of expertise in chemical and biological (CB) defence and conducts world-class research and development in CB defence, to provide the Canadian Forces with the advice and equipment needed to counter the hazard from the use of CB weapons. ( www.suffield.drdc-rddc.gc.ca ).
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(TM) 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
For further information
Jeffrey D. Turner, Ph.D., President and CEO, Nexia Biotechnologies Inc., (450) 424-8920 or email@example.com
Source: NEXIA BIOTECHNOLOGIES INC.
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