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GI Toxicity Models

Epistem's extensive knowledge of the gastrointestinal epithelium has been translated into models to assess the effects of novel therapeutic agents on the GI tract.

Epistem's Models for Assessing Gastrointestinal Toxicity of Novel Therapeutic Agents

Understanding Mechanisms of Action and Defining Dosing Regimens for Improved GI Safety Profiles

An important consideration in the development of a novel therapeutic agent is the potential for off-target effects on the GI tract. The cells lining the crypts of the small intestine are the most rapidly proliferating in the body and therefore sensitive to the effects of many therapeutic agents. Damage to stem cells within the intestinal crypts leads to cell and villus loss, ulceration and inflammation of the epithelium, compromising the integrity of the GI tract.

Novel therapeutic agents which affect cell proliferation may induce hyperplasia, causing bowel obstruction and increasing the risk of developing cancer. Agents which affect cell differentiation can influence mucin production and absorptive function, impacting on the efficiency and integrity of the GI tract.

Epistem’s models can be used to understand the potential to cause GI toxicity and define the mechanism of action. Once understood, it may be possible to determine a dosing regimen with an improved GI safety profile.


GI toxicity models:

  • In Vitro GI Models – in vitro cytotoxicity and Epistem’s proprietary Primequant® model
  • In Vivo GI Models – target cell population, mechanism of action and pK/pD response

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