XenoTech Receives US Patent for Its Novel Approach to Evaluate Therapeutic Proteins as Immune Modulators of Drug Metabolism
Lenexa, KS- XenoTech has been awarded US patent # 8,846,576 “In Vitro Test System to Evaluate Xenobiotics as Immune-Modulators of Drug Transport and Metabolism in Human Hepatocytes”.
XenoTech’s newly patented in vitro process evaluates biologics for direct and cytokine-mediated effect on cytochrome P450 enzyme expression. The cytokine release assay is the first step in the process, followed by examination of biologic-stimulated plasma in primary co-cultures of human hepatocytes and Kupffer cells. Consideration is given to the appropriate drug concentration that will yield the most relevant data on the release of cytokines for improved clinical prediction and impact surrounding biologics exposure. Our patented and novel approach yields cytokine release information and detects the direct and cytokine-mediated effects of biologics on CYP expressions and other metabolizing enzymes or transporter expressions.
The most recent FDA Guidance for Industry on drug interactions recognizes the potential for therapeutic proteins that are cytokines or cytokine modulators, to change the plasma concentration of specific enzyme and transporter mediated substrate drugs. Therapeutic proteins, which typically are not cleared by metabolism or transport involved in clearance of small molecule drugs, can suppress drug metabolizing enzymes and transporters by evoking response of the pro-inflammatory cytokines.
Increasing numbers of therapeutic proteins, known as biologics, are being introduced to the market. These drugs can trigger the release of pro-inflammatory cytokines (e.g. IL-1β, IL-6, INFγ and TNFα) from peripheral blood mononuclear cells. Extreme cases of cytokine release are known as a cytokine storm, cytokine cascade or hypercytokinemia, and can lead to potentially life-threatening immune reactions. In vivo cytokines released in response to certain biologic drugs, as well as, in response to inflammation or infection, regulate multiple physiological processes including drug transport and metabolism. Cytokine-mediated suppression of drug metabolizing enzymes can change the clearance of small molecule drugs and thereby precipitate a drug-drug interaction.
“We are committed to continuing to drive innovative approaches to bridge the gap between in vitro and in vivo outcomes as it pertains to current technologies in drug development which ultimately impact the human health arena. This body of work and patent that Dr. Maciej Czerwinski and other XenoTech scientists have pioneered is just one more example of that. We are extremely proud of the work they do and the impact it has on advancing the knowledge base of the industry,” stated EVP and COO, Jason N. Neat.
For more information regarding our newly patented and novel approach, please contact us using the information below.
XenoTech, LLC is a global Contract Research Organization with unparalleled experience and expertise in evaluating drug candidates, nutraceuticals, cosmetics, food additives and other compounds widely known as xenobiotics, substrates, inhibitors and inducers of cytochrome P450, UGT and other drug metabolizing enzymes and drug transporters. The company offers a variety of in vitro and in vivo safety assessment studies for drug candidate evaluation, as well as an extensive selection of products for drug metabolism research. XenoTech’s product selection includes a wide-range of high quality standard reagents, from subcellular fractions and hepatocytes to recombinant enzymes, substrates and metabolites. The company can also prepare and deliver custom-designed products and services in respnose to client requests. For additional information, please refer to the company’s website at www.xenotech.com or call (913) 438-7450.