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Overview

KineMed was founded in 1999 to provide kinetic solutions to fundamental problems in disease management and drug development. Although it is widely recognized that all biological systems are characterized by flux (polymers are synthesized and degraded; metabolite traverse pathways to provide energy; cells die and are replaced), virtually no tests in biomedicine in the year 2004 measure dynamic fluxes of molecules. A void therefore exists in the contemporary drug development/diagnostic repertoire, analogous to the state of photography before the development of moving pictures. KineMed's tests, termed KineMarkers™, fill this void by measuring molecular kinetics in living systems, including humans. This technology, patented at the University of California and licensed exclusively to KineMed, is the only commercially available technology that measures molecular kinetics in living organisms. It is based on the combination of highly sensitive mass spectrometry and the labeling of molecular pathways with non-radioactive tracers in vivo. There are currently 5 issued and 30 pending patents to KineMed, mostly via the University of California. Among them, 3 issued U.S. patents relate to the measurement of cell proliferation and destruction rates in vivo and in vitro with stable isotopes.

This technology provides the tools necessary to measure the ability of a drug to intervene in a targeted disease process, in animals and humans, and follow the natural course of metabolic events in the pathways of disease and health. This is a true biomarker of drug effect and not a surrogate of presumed effect or statistical manipulation. The time to drug effect, or lack thereof, is measured in hours or days not months or years. The strategic and economic consequences of this invention on drug discovery and clinical development are substantial. KineMed's assays are applicable at every level of the drug development-drug approval process as well as advanced medical diagnostic and therapeutic applications.

KineMed's technology is based on the principle that the operational unit of function in complex biological systems is neither the gene nor the protein, but rather is the flow of molecules through metabolic pathways in fully assembled living systems. In the final analysis, it is the flow of molecules through synthetic, catabolic and intermediary metabolic pathways that is responsible for phenotype, structure and adaptation in biological systems.

KineMed's assays combine highly sensitive mass spectrometry and the labeling of critical molecular pathways with stable, non-radioactive isotopes in living organisms, including humans. The development of this technology allows for the measurement of molecular fluxes in metabolic pathways critical to human health and disease. The stable isotopes can be delivered by essentially any route of administration, are safe for use in humans and the isotopic enrichments of a number of metabolic pathways may be determined in a high-through put manner. These kinetic assays have been broadly applied to a vast array of human disease states including cancer, Alzheimer's, diabetes, multiple sclerosis, HIV, arthritis, fibrogenesis, and lipid disorders.

These assays differ from other diagnostic measures in two fundamental ways: first, they measure the activity of intact metabolic pathways in living organisms (i.e., they do not measure the state of component parts and they do not need to be limited to use in model systems) and, second, they involve the dimension of time, and thus incorporate motion (dynamics). These two elements are absent from essentially all contemporary diagnostic tests in clinical medicine and drug development.

The KineMed technology fills this vital gap in the current repertoire of contemporary biomedicine and provides a direct pathway to products.

The scientific team includes three M.D./Ph.D.s and twelve Ph.D.s. All scientists have extensive postdoctoral experience, and many have extensive prior experience in the development and use of KineMarkers™ and related enabling technologies.

The business team has a long and successful track record of developing, financing, and growing companies into large successful enterprises, including NASDAQ-listed biopharmaceutical companies. Strength in both scientific and business aspects allows KineMed to pursue external academic and industry-based collaborations as well as internal laboratory programs for expedited development and commercialization of its technologies and proposed products.

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