IV. The Chemical Biological Medical Systems Joint Project Management Office (CBMS-JPMO), Frederick, MD
- Focus: The critical objectives of CBMS-JPMO are to develop, procure, field, and sustain premier medical protection and treatment capabilities against chemical and biological warfare agents.
- The Challenge: There was a need to develop animal models for pre-clinical trial studies in incremental Bioscavenger therapeutic research and development (R&D) under the Medical Identification and Treatment Systems (MITS), as well as for physiologically based pharmacokinetic/pharmacodynamic (PBPK/PD) models that simulate the concentrations, effects and mitigation of low-level CWA exposures by huBChE enzyme therapy. Because of the complex structure of cholinesterases, mutations, post-translational modifications, and genetic variation there is the potential for different CWA binding and immune responses during purified enzyme therapy.
- Our Approach: We provided scientific subject matter experts (SMEs) experienced in CWA R&D, preclinical animal studies, toxicology and the FDA regulatory process in order to determine the binding characteristics of sarin in Gottingen Minipig® blood following pretreatment with human plasma-derived butyrylcholinesterase and subsequent inhalation exposures.
- Our Solution: We assisted MITS in the design and implementation of pre-clinical studies using a new animal model, called Gottingen minipigs®. Minipigs are accepted non-rodent models in pharmacology and toxicology. Studies performed on minipigs are fully recognized by regulatory authorities worldwide, including the FDA. These animals have been used successfully in a variety of research applications. The impact of the work will have important implications for medical treatment of CWA exposures and for veterans diagnosed with Gulf War Syndrome.
- Business Gain:The DoD will develop Bioscavenger in three increments. Bioscavenger 1, 'pBioscavenger', is huBChE, the naturally occurring protein isolated from human plasma. This product is being developed as an interim solution through completion of a Phase 1 clinical trial in humans. Bioscavenger 2 is Protexia®, a recombinant huBChE produced in the milk of transgenic goats and chemically modified by attachment of polyethylene glycol polymers ('PEGylation'). PEGylation of the protein will improve its half-life in circulation. The recombinant technology is potentially a less expensive method of producing huBChE. Bioscavenger 3 will be catalytic Bioscavenger, which will actively degrade nerve agents without losing its own activity.
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