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AUSTIN, TX, United States

Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 150.96K | Year: 2014

? DESCRIPTION (provided by applicant): Personal care products (PCPs) are non-prescription products applied to the body (e.g., hair colorants, shampoos, conditioners, skin lotions, deodorants, suntan lotions, lipstick, makeups, nail polishes, etc.). Daily, the average consumer uses 10 cosmetic products, totaling 126 ingredients, most not listed on the label. Peer- reviewed papers report that ingestion or absorption of chemicals having estrogenic and/or androgenic activity (EA**/AnA**) by mammals (including humans) can possibly cause various adverse health effects including uterine dysfunction, higher rates of some cancers, reduced sperm count, and abnormal brain maturation, disorders of attention, motivation, emotion, cognitive development, and changes inaggressive behavior and sexual orientation. These adverse effects may sometimes occur at very low (picomolar to nanomolar) concentrations, especially on fetal or developing mammals. CertiChem's (CCi's) peer-reviewed papers and preliminary data show that P


Grant
Agency: National Science Foundation | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 99.88K | Year: 2009

This award is funded under the American Recovery and Reinvestment Act of 2009 (Public Law 111-5). This Small Business Innovation Research Phase I project will confirm that it is feasible to identify food antioxidants (AOs) to make formulations that have no detectable estrogenic activity (EA) or anti-EA (EA-Free) or have well-specified levels of EA (EA-Specified AO formulations). This project is innovative because food AOs have not previously been examined for levels of EA, especially after common-use-stresses of sterilizing or microwaving. CertiChem is uniquely qualified to develop and commercialize EA-free/EA-specified AO formulations because of its exclusive patents and experience in bringing EA-Free products to market. The broader impacts of this research are that CertiChem's data show that most current food AOs have EA in unknown concentrations. CertiChem proposes to develop AO formulations that are EA-Free or have well-specified levels of EA. Chemicals having EA at concentrations used in foodstuffs (mM to uM) often have adverse effects on mammals, including humans. Fetal or juvenile mammals are especially sensitive to effects of chemicals having EA at very low dosages (nM to pM concentrations). Conversely, some conditions in adult humans (e.g., menopause, some cancers or abnormalities of the prostate) are probably ameliorated by chemicals having well-specified levels of EA. CertiChem is raising consumer awareness by actively working with NGOs and legislators to educate the public on health risks or benefits associated with chemicals that have EA. Significant consumer demand for EA-Free products or EA-Specified products is already observed.


Grant
Agency: National Science Foundation | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 500.00K | Year: 2010

This Small Business Innovation Research (SBIR) Phase II project will use state-of-the-art assays to detect estrogenic activity (EA) and anti-EA in antioxidants (AOs). Chemicals like AOs that have EA or Anti-EA (EA**) produce adverse health effects, including reproductive and behavioral disorders and some cancers. AOs have not been examined for EA**, much less AO packages reformulated to have specific levels of EA for specific commercial applications. This project will assess the EA** of 10 additional organic AOs, and 15 EA-**Free/EA**-specified formulations made from combinations of conventional, organic, water-soluble, and oil-soluble AOs that are stable when exposed to common-use stresses. These AO formulations will be used by identified partners to produce animal feeds, cereals and other foodstuffs that are EA**-free or have well-specified levels of EA** providing a clear path to commercialization and additional patents. The broader impacts of this research are that fetal or juvenile mammals, including humans, are especially sensitive to chemicals having EA** at very low dosages and should not indiscriminately ingest such chemicals. Conversely, other conditions (e.g., menopausal symptoms, some cancers or abnormalities of the prostate) are ameliorated by chemicals having controlled levels of EA**. Hence, this project will minimize the risks of unintentional consumption of chemicals having EA** by using EA**-free AOs in products such as cereals and baby formulas or specified-EA** AOs in products such as fitness drinks and dietary supplements for post-menopausal women.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase I | Award Amount: 121.76K | Year: 2006

DESCRIPTION (provided by applicant): Recent scientific investigations have shown that many chemicals used in plastics, Pharmaceuticals, pesticides, cosmetics, food additives, etc., are endocrine disrupters (EDs). EDs interfere in various ways with hormones such as estrogens to have significant adverse effects on many behavioral and physiological processes. ED effects (e.g. estrogenic or anti-estrogenic) sometimes occur at very low (picomolar to nanomolar) concentrations, especially on fetal or developing mammals (including humans). The prevalence and actions of EDs in our environment warrant the development of valid assay methods. Consequently, various governmental bodies (e.g., EPA, FDA, and ICCVAM) and proactive corporations have explicitly expressed a desire to have in vitro robotic assays for EDs, such as anti-estrogenic activity (anti-EA). However, no anti-EA assay is commercially available. To begin to meet these governmental, scientific and commercial needs, CertiChem (CCi) has preliminary data suggesting that it is feasible to develop an anti-EA robotic assay that would be valid (i.e., reliable, accurate, versatile, rapid, and cost effective) using MCF-7 cells. In this Phase I application, CCi now proposes to confirm that it is feasible to develop a robotic assay for anti-EA by first determining an optimum robotic protocol for detecting anti-EA using MCF-7 cells. CCi then proposes to estimate the reliability (reproducibility) of this assay by repeatedly (5 times) assaying over a 12 week period a limited set of reference chemicals (10) published by ICCVAM to use for validation of anti-EA assays (Specific Aim #1). CCi also proposes (Specific Aim #2) to estimate the accuracy of this assay by comparing data CCi obtains on these 10 reference chemicals with data published by ICCVAM. We strongly expect data obtained on this Phase I grant to confirm our preliminary data that this anti-EA assay is worthy of more extensive testing and development in a Phase II study to prepare it for commercialization. Development of a robotic screening assay for anti-EA is commercially, scientifically, and socially important because of the large number of chemicals (>10,000) - much less chemical mixtures - that should now be screened for anti-EA by profit, non-profit, or governmental entities. Development of a robotic assay for anti-EA is desired as part of the mission of NIEHS, EPA and ICCVAM.


Grant
Agency: Department of Health and Human Services | Branch: | Program: SBIR | Phase: Phase II | Award Amount: 476.51K | Year: 2007

DESCRIPTION (provided by applicant): Recent scientific investigations have shown that many chemicals used in plastics, pharmaceuticals, pesticides, cosmetics, food additives, etc., are endocrine disruptors (EDs). EDs interfere in various ways with hormones such as estrogens to have significant adverse effects on many behavioral and physiological processes. ED effects (e.g. estrogenic or anti-estrogenic) sometimes occur at very low (picomolar to nanomolar) concentrations, especially on fetal or developing mammals (including humans). The prevalence and actions of EDs in our environment warrant the development of valid assay methods. Consequently, various governmental bodies (e.g., EPA, FDA, and ICCVAM) and proactive corporations have explicitly expressed a desire to have in vitro robotic assays for EDs, such as anti-estrogenic activity (anti-EA). However, no robotic anti-EA assay is commercially available. To begin to meet these governmental, scientific and commercial needs, CertiChem (CCi) has completed a Phase I SBIR grant showing that it is feasible to develop an anti- EA robotic assay that would be valid (i.e., reliable, accurate, versatile, rapid, and cost effective) using MCF-7 cells. In this Phase II application, CCi now proposes to develop this robotic assay for anti-EA for commercialization by repeatedly assaying a set of 78 reference test chemicals to confirm the reliability and accuracy of CCi's proposed anti- EA assay. CCi also proposes to demonstrate the versatility of this assay by examining the anti-EA in a set of antioxidants used in foodstuffs and plastics. Finally, CCi proposes to perform HPLC separation assays on some reference test chemicals to confirm that their anti-EA is not due to contamination and to enhance the versatility of this assay for commercial use. Development of a robotic screening assay for anti-EA is commercially, scientifically, and socially important because of the large number of chemicals (>10,000) - much less chemical mixtures - that should now be screened for anti-EA by profit, non-profit, or governmental entities. Development of a robotic assay for anti-EA is desired as part of the mission of NIEHS, EPA and ICCVAM. Recent scientific investigations have shown that many (perhaps over 10,000) chemicals used in common products such as plastics, pesticides, cosmetics, and food additives have estrogenic/anti-estrogenic activities that severely interfere with normal estrogen actions to produce adverse effects on many behavioral, reproductive, and physiological processes in humans. In this Phase II proposal, CertiChem (CCi) proposes to develop a very sensitive and accurate assay to measure anti-estrogenic activity in a set of reference test chemicals and in common consumer products. CCi proposes to use these data and CCi's data on estrogenic activity on many chemicals to identify which chemicals have anti-estrogenic activity and to work with various firms to design consumer products that are free of chemicals that release anti-estrogenic or estrogenic activities.

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