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Nexia Announces that Protexia(TM) Meets Military`s Primary Objective; In Vivo Efficacy Milestone Thursday January 22, 8:01 am ET MONTREAL, Jan. 22 /CNW Telbec/ - Nexia Biotechnologies Inc. (TSX: NXB - News) reported today positive results from the Protexia(TM) in vivo efficacy studies conducted by the U.S. Army`s Institute for Chemical Defense (ICD). The studies evaluated the ability of Protexia(TM), 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(TM) from the milk of transgenic goats and ICD evaluated Protexia(TM) 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(TM)`s in vivo efficacy is an important independent assessment. Protexia(TM) 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(TM) can both protect animals and neutralize a wide range of nerve agents", commented Jeffrey D. Turner, President and CEO of Nexia Biotechnologies Inc. 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(TM) via our transgenic goats and initializing the development toward making clinical grade Protexia(TM). Nexia is working jointly with the USAMRMC under a Broad Agency Announcement (BAA) contract and a Cooperative Research and Development Announcement (CRADA), and a Memorandum of Understanding with Defence R&D Canada Suffield (DRDC Suffield) to advance Protexia(TM). 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. Today`s results mark the successfully completion of this milestone. - Thirdly, ongoing early pre-clinical tests, including pharmacokinetic studies, to determine residence time of Protexia(TM) in animal models, should yield results shortly. The data generated from these experiments clearly showed similarities between Protexia(TM) 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(TM), would likely be required to present extensive animal efficacy data along with human safety data. In February 2003 pyridostigmine bromide (PB), 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(TM), if and when approved by regulatory authorities, may be used for prophylaxis and treatment in military markets. Additionally, Protexia(TM) could also be used by local law enforcement and first responder personnel. Prophylaxis involves the pre-treatment of military personnel and civilian first responders who may be exposed to nerve agents. The treatment indication of Protexia(TM) 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(TM) program can be obtained at www.nexiabiotech.com . Conference Call and Web cast Nexia will be holding a conference call on this matter in conjunction with is Annual General Meeting, its Programs Updates and its First Quarter 2004 Financial Statements Update on January 28, 2004 at 16:10, and this call will be broadcast live on the web at www.nexiabiotech.com . About Nexia Nexia develops and manufactures complex recombinant proteins in the milk of transgenic goats for medical and industrial 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 investigated initially for use as a pre-treatment or treatment for military personnel to counter the toxic effects of nerve agents. Other potential uses of Protexia(TM) include detection and decontamination systems as well as treatment for insecticide poisoning and cocaine overdose. 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 . 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. Please refer to USAMRICD`s web site at: http://chemdef.apgea.army.mil/ . 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 success. http://www.newswire.ca/en/releases/orgDisplay.cgi?okey=35334 For further information For additional Media and Investor Relations: Jeffrey D. Turner, Ph.D., President and CEO, Nexia Biotechnologies Inc., 450-424-8920 or at jturner@nexiabiotech.com -------------------------------------------------------------------------------- Source: NEXIA BIOTECHNOLOGIES INC. |
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| aus der Diskussion: | Nexia Biotech- große Zukunftsaussichten |
| Autor (Datum des Eintrages): | Bombenleger (28.02.04 10:36:12) |
| Beitrag: | 20 von 43 (ID:12284523) |
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