spacer
home > news > detailed info
INDUSTRY NEWS AND PRESS RELEASES

SEKISUI XenoTech Receives New US Patent for a Method to Evaluate Xenobiotics as Immune-Modulators of Drug Transport and Metabolism in Hepatocytes

SEKISUI XenoTech

Tuesday, May 12, 2020

Kansas City, KS- SEKISUI XenoTech has been awarded US patent # 10,648,968 “In vitro test system to evaluate xenobiotics as immune-modulators of drug transport and metabolism in human hepatocytes.”

 In 2014, SEKISUI XenoTech patented an in vitro test system to evaluate whether an immuno-modulating drug can change expression of drug metabolizing enzymes in human hepatocytes and how it will interact with human hepatocytes. Xenobiotic metabolism is a core interest of SEKISUI XenoTech, and the company has now received this divisional patent to cover small molecule drugs in addition to the previously patented method that covered biologics or large molecule drugs.

Developed by Dr. Maciej Czerwinski, this in vitro process evaluates drug candidates for direct and cytokine-mediated effects on cytochrome P450 (CYP) enzyme expression. The original patent was for examination of biologic drugs and this divisional patent expands application of the invented test system for evaluation of small molecule drugs. First, the cytokine release assay examines the effects of the drug on the level of cytokines in the whole blood ex vivo. In the second step, effects of the cytokines on the expression of drug-metabolizing enzymes are evaluated in hepatocytes in vitro. Consideration is given to the appropriate drug concentration that will yield the most relevant data on the release of cytokines and their downstream impact. Our patented and novel approach yields cytokine release information and detects the direct and cytokine-mediated effects of small molecules on CYP and drug transporter expression.

Small molecule drugs still encompass the majority of compounds in development and increasingly these molecules are designed to modulate the immune system. Those that may be associated with the release of pro-inflammatory cytokines warrant evaluation before first in-human (FIH) clinical trials. Examination of cytokines stimulated by small molecule drugs is important since these signaling molecules can suppress drug-metabolizing enzymes. Cytokine-mediated suppression of drug metabolizing enzymes can change the clearance of concomitantly administered small molecule drugs and thereby precipitate a drug-drug interaction.

FDA recognizes the potential for drugs that are cytokines or cytokine modulators to change the plasma concentration of co-administered drugs. “It is crucial for developers and testing organizations to evolve and rise to meet new technological advances. As improvements are made in the way therapies are developed it is important to provide innovation and processes that match the needs of drug developers. SEKISUI XenoTech is committed to driving innovation as a means of supporting both safety assessment and effective pipeline development for our clients. We are also constantly adapting to stay abreast of the latest advances and provide expertise on the effects of drugs and the regulatory policies to protect potential patients. We are extremely proud of the work we do and the expanding expertise of our scientists,” stated VP of Scientific Consulting, Dr. Brian Ogilvie.

For more information regarding this newly patented and novel approach, please visit www.xenotech.com or contact SEKISUI XenoTech using the information below.
phone Phone: +1.913.438.7450 Toll-Free (North America): 1-877-588-7530
email info@xenotechllc.com
web https://www.xenotech.com/home
email 1101 West Cambridge Circle Dr. Kansas City, KS 66103
 
Print this page
Send to a friend
   
spacer
News and Press Releases

ERT Virtual Visit Capabilities Keep Clinical Trials on Track during COVID-19

ERT, a global data and technology company that captures critical endpoint data while minimizing uncertainty and risk in clinical trials, today announced a Virtual Visit solution that enables the continuation of clinical trials during and after current global stay-at-home mandates. As a result of COVID-19, many clinical trials have been delayed as healthcare providers focus their efforts on patients who require urgent care, which limits clinical trial patients’ access to investigative sites for routine visits.
More info >>


White Papers

Analysis of Biopharmaceuticals to Conform to ICHQ6B

RSSL

Worldwide, the pharmaceuticals market is anticipated to grow from more than USD 782 billion in 2011 to approach a value of just over USD 971 billion by the end of 2016, registering a CAGR of over 24%. In 2010 the average medicines expenditure per person within the UK was £271, and this is expected to increase with the ageing population. A significant and increasing proportion of these sales are protein-based biotherapeutics or biomolecules. Currently, these account for 19% of the total market, and are growing at twice the rate of traditional small molecule pharmaceuticals. It is predicted that close to 50% of the top 100 pharmaceutical products will be biomolecules by 2016. By far the largest segment of the biopharmaceutical market is the monoclonal antibody (MAb) with an estimated share of 25.6%, which corresponds to USD 51.1 billion.
More info >>

Industry Events

Outsourcing in Clinical Trials Europe

26-27 October 2020, Paris, France

Arena International are delighted to announce the return of Outsourcing in Clinical Trials Europe. Part of our global series of events, this flagship show will attract the leading clinical professionals from across Europe. The 10th Annual event will be hosted in Paris.
More info >>

 
©2000-2011 Samedan Ltd.
Add to favourites

Print this page

Send to a friend
Privacy statement