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CREVE COEUR, MO, United States

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 238.25K | Year: 2006

DESCRIPTION (provided by applicant): URINALYSIS FOR PATIENT COMPLIANCE TO CAM THERAPY: In recent years, with increasing dissatisfaction with modern medicines coupled with a desire for healthy living, there has been a dramatic increase in the use of complementary and alternative medicines (CAM). However, rigorous testing of CAM methods is needed to prove efficacy before it can be accepted in regular practice. Outpatient trials can only work if patients adhere to the therapeutic protocol. Currently, assessment of adherence is done by patient reports, pill counts and with electronic monitoring devices. The financial burden of non-adherence is estimated to cost $100 billion each year in the United States. Our goal in this application is to develop a technique to monitor patient adherence to CAM techniques using urinalysis. Towards this, we propose to develop a rapid, real-time assay to determine the effectiveness of constituents of biologically active CAM agents in body fluids. The assay is based on an in vitro bioluminescence imaging system. Ultimately, we plan to develop a non-invasive urinalysis kit. A critical cellular factor that is involved in controlling many normal cellular and organismal processes, including immune and inflammatory responses, cellular growth, and apoptosis is the transcription factor NF-kappaB. Of greater significance is that NF-kappaB is continually active in numerous disease states and is present as a latent, inactive, I-kappaB-bound complex in the cytoplasm. I-kappaB is a complex of three subunits. Following stimulation by an extracellular signal, the alpha subunit of I-kappaB is targeted for phosphorylation followed by ubiquitination and proteosomal degradation. Phosphorylation of I-kappaBalpha releases it from the NF-kappaB complex and the unmasked NF-kappaB complex can then enter the nucleus to activate target gene expression. CAM agents, such as curcumin, are known to inhibit I-kappaB phosphorylation, thereby inhibiting NFkappaB activation and suppressing pathophysiological processes. The primary objective of this project is to develop sensitive, non-invasive kits and assays for use in the detection of biologically active CAM agents, their constituents or metabolites in body fluids, such as blood or urine, as a way of assessing adherence to well-described clinical trial protocols. Towards this goal, we propose to validate an in vitro biological assay system using I-kappaB stabilization to determine the amount of metabolites of common CAM agents in urine (non-invasive procedure), to ultimately develop reagent kits and consumables. The Phase I effort will establish proof-of-principle for the detection and measurement of the CAM agents, such as turmeric, black raspberries and broccoli, potent anti-inflammatory agents, in the efficacy of I-kappaB degradation. I-kappaB is a critical factor involved in the inflammatory pathway and plays a vital role in NFkappaB activity. We believe that this technology will enhance and complement existing HPLC/mass spectrophotometry techniques in the accurate assessment of the use of CAM agents - before, during and post clinical trials. It is anticipated that the availability of this I-kappaB degradation and measurement system will promote the development of validated CAM agents for use by consumers, patients, industry, regulatory agencies, and clinical researchers. In Addition, this GEM tool will enable both the research and commercial entities to perform molecular and functional in vitro and in vivo studies and offer exciting new opportunities in the field of complementary and alternative medicine.

Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 523.02K | Year: 2007

DESCRIPTION (provided by applicant): The scientific and commercial goal of this small business innovation research (SBIR-Phase II) proposal is to develop cell-based assays for the detection of biologically active complementary and alternative medicine (CAM) agents in body fluids. The proposed project builds on the foundation of a molecular assay designed and validated through a recent Phase I funding. The strategy of identifying CAM agents in body fluids by an in vitro bio-luminescence imaging system complements another drug-discovery technology developed at Swaasth Inc, referred to as Genetic Expression and Measurement (GEMTM). Together, these cell-based CAM agent detection technologies will enable the development of novel technologies in monitoring objective measures of adherence to study-protocol in the investigations of CAM modalities. Swaasth Inc. has successfully developed molecular reagents and high throughput-screening infrastructure required to identify CAM agents. It is anticipated that the availability of GEM system will make effective use of the Phase II funding to further expand the detection of a variety of CAM agents and enhance minimally invasive patient adherence measurements for CAM modalities in clinical settings.

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