In 2017 KMT Hepatech became part of PhoenixBio group and will continue operations and services utilizing PXB-Mouse®,
Due to the expanding interest in the humanized liver mouse model across a wide range of drug development fields, the company now offers services in the following areas:
Hepatitis C, Hepatitis B,
The extension to other pathogens with obligate life cycles in the liver could greatly broaden the impact of the chimeric mouse model. One such example is malaria, which remains one of the greatest killers in history.
The most dangerous form, Plasmodium falciparum, must undergo maturation in human hepatocytes before it is capable of reinfecting human red blood cells; a vaccine targeting the liver stage of the life cycle might prevent blood infection completely.
The PXB-Mouse® is an excellent model capable of examining the entire life cycle of the parasite, and will aid in the development of inexpensive therapies to supplement preventative measures in endemic areas.
Human Hepatic Toxicity Studies of Drugs or Chemicals
Drug-induced liver injury (DILI) is one of the most frequent causes of safety-related withdrawal of drugs from the market. However, predicting which drugs will prove toxic to the liver is extremely difficult.
Due to interspecies differences in hepatic toxicity, the results obtained in vivo from rodents and dogs are not always relevant in predicting the responses of human hepatocytes. Human hepatocytes in primary culture and precision cut liver slices are used for in vitro characterization of human hepatic toxicity, but do not preserve the architecture of the liver sufficiently to allow an accurate prediction of future reaction of human hepatocytes.
Too often, DILI and other toxicity problems are only identified late in drug development. According to a report from the Society for Medicines Research, just a 10% improvement in predicting failure before the start of clinical trials could cut the costs of drug development by upwards of €75 million.
Human-Specific Metabolism of Drugs or Chemicals
The importance of prediction of human drug metabolism and pharmacokinetics during the preclinical stage of drug development is hard to overstate. It contributes to both efficacy and toxicity of the drug in development. Due to interspecies differences in hepatic metabolic patterns, the results obtained from rodents and dogs are not always relevant in predicting the responses of human hepatocytes. Liver microsomes, human hepatocytes in primary culture and precision cut liver slices are frequently used for early characterization of human metabolism, but do not preserve the architecture of the liver sufficiently to allow an accurate prediction of which metabolites will likely circulate.
Given the limitations of current preclinical models, human metabolites and their downstream effects often go undetected until clinical trials, the most costly and risky phase of drug development.
Categories of Scientific Evaluations Performed
Proof of concept: vehicle versus drug treatment
Dose response study
Combination therapy study
Head-to-head comparison of different drugs
In vivo resistance evaluations
Prediction of dosage ranges for clinical trials
Evaluation of preventive therapies
Human-type drug metabolism evaluation
Human lipoprotein metabolism and therapies
Assessment of hepatotoxicity
Our scientists work closely with your scientific team, utilizing a collaborative approach to develop an evaluation strategy that meets your priorities and needs. We will customize studies to answer your most urgent questions related to the evaluation of a potential product and to provide you with the highest possible level of assurance that your lead candidate meets your expectations prior to entering clinical trials.
For each client relationship, a joint Research Steering Committee monitors progress and directs the research agenda. This ensures the client achieves their research objectives according to their timeline and their budget utilizing the PXB-Mouse®.
SC max volume 1 ml
IM max 0.05 ml 1x daily
IP max up to 15 ml/kg
IV max 0.1 ml
Frequency and duration of dosing regimes assessed per individual study protocol development and are governed by guidelines set by the CCAC and local ACC review.