Cancer Drug Efficacy

Human xenograft implants in nude athymic mice or syngeneic transplants in appropriate rodent models are the industry standard for assessing the success of an anti-cancer agent, whether the compound works by directly affecting the growth of the tumor or by controlling processes such as angiogenesis. Tumor cell cultures or tumor fragments are implanted either ectopically or orthotopically and the tumors grown to a specified size. The animals are randomized, placed into groups, and the test groups are treated with a prescribed drug regimen over the test period. Typically, tumor sizes are measured twice a week and body weight's once a week. The animals are sacrificed at the end of the test period and tissues are removed for pathological evaluation. There are a number of sources for obtaining cancer cell lines (e.g, the American Type Culture Collection). Whenever possible, we like the client to supply the cell line so that the in vivo studies are performed from the same cell line source as the initial in vitro studies. Some tumor lines that we commonly use in tumor studies are listed below.

A typical efficacy study design involves administering one or more drugs of unknown efficacy to tumor-bearing mice. Additionally, reference chemotherapeutic agents (positive control) and negative controls are similarly administered and maintained a typical human xenograft tumor study.

• Animal Tumor Model: Species, strain, sex, age and tumor type are selected for the study.
• Experimental Design: MDS scientists work together with the sponsor to develop a detailed protocol specifying all aspects of the study.
• Test Article Administration: Routes of administration include subcutaneous (SC), intraperitoneal (IP), intravenous (IV), intramuscular (IM) and oral ( PO ).
• In-life Data Collection: Tumor measurements and body weights are taken over the course of the study and morbidity and mortality are recorded.