Nexia's Protexia shown to protect animals
2004-01-22 08:24 ET - News Release
Dr. Jeffrey Turner reports
NEXIA ANNOUNCES THAT PROTEXIA(TM) MEETS MILITARY'S PRIMARY OBJECTIVE; IN VIVO EFFICACY MILESTONE
Nexia has received positive results from the Protexia in vivo efficacy studies conducted by the United States Army's Institute for Chemical Defense (ICD).
The studies evaluated the ability of Protexia, a recombinant form of human butyrylcholinesterase (BChE), to protect laboratory animals from the toxic effects of nerve agents. The experimental program is a technical collaboration between ICD and Nexia. Nexia purified the Protexia from the milk of transgenic goats and ICD evaluated Protexia for its ability to protect animals from the toxic effects of organophosphate nerve agents. The results of these studies will be the subject of a peer reviewed, joint publication from the U.S. Army Medical Research and Materiel Command (USAMRMC) and Nexia later this year.
"The U.S. Army's demonstration of Protexia's in vivo efficacy is an important independent assessment. Protexia clearly protected all the animals in the study. These positive in vivo efficacy results with recombinant BChE are consistent with the army's research experience with plasma-derived BChE. We now know that Protexia can both protect animals and neutralize a wide range of nerve agents," commented Jeffrey D. Turner, president and chief executive officer of Nexia Biotechnologies. A recombinant source of BChE is important if the full-market needs for bioscavengers like BChE are to be realized to protect DoD personnel and treat the public. This has created great impetus for expanding the production of Protexia via the company's transgenic goats and initializing the development toward making clinical grade Protexia.
Nexia is working jointly with the USAMRMC under a broad agency announcement (BAA) contract and a co-operative research and development announcement (CRADA), and a memorandum of understanding with Defence R&D Canada Suffield (DRDC Suffield) to advance Protexia.
Protexia program update
Under the Protexia 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 of a variety of nerve agents, including soman, sarin, VX and tabun. This was successfully achieved on Nov. 20, 2003;
the second was to perform in vivo challenge studies with nerve agents to demonstrate that Protexia is efficacious as a protective agent in animal models. Today's results mark the successfully completion of this milestone; and
thirdly, continuing early preclinical tests, including pharmacokinetic studies, to determine residence time of Protexia in animal models, should yield results shortly.
The data generated from these experiments clearly showed similarities between Protexia and HuBChE and thus are important for the decision to transition into a development program and attract additional government development funding. Studies with HuBChE in rodents and non-human primates have demonstrated significant protection against the lethal effects of nerve agent intoxication.
Based on regulations published by the U.S. FDA Animal Efficacy Rule (Federal Register 67 (105) pg. 37988-98, May 31, 2002), there is now an established regulatory pathway for FDA review for medical countermeasures for chemical weapons defence. Under this legislation, efficacy studies on humans to demonstrate protection from nerve agents would be considered unethical. Products, like Protexia, would likely be required to present extensive animal efficacy data along with human safety data. In February, 2003, pyridostigmine bromide, was the first drug to be licensed by the FDA under these rules.
Based on discussions with both USAMRICD and DRDC Suffield, Nexia believes that Protexia, if and when approved by regulatory authorities, may be used for prophylaxis and treatment in military markets. Additionally, Protexia could also be used by local law enforcement and first responder personnel. Prophylaxis involves the pretreatment of military personnel and civilian first responders who may be exposed to nerve agents. The treatment indication of Protexia would be a therapy for casualties on the battlefield or victims of terrorist nerve agent attacks.
More information concerning a general description and background of BChE and the Protexia program can be obtained at www.nexiabiotech.com.
Conference call and Webcast
Nexia will be holding a conference call on this matter in conjunction with its annual general meeting, its programs updates and its first quarter 2004 financial statements update on Jan. 28, 2004, at 16:10, and this call will be broadcast live on the Web at www.nexiabiotech.com.
About USAMRMC
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.
WARNING: The company relies upon litigation protection for "forward-looking" statements.
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