NEW YORK (GenomeWeb News) — EpiStem, a UK company focused on developing epithelial stem cells from human hair, said today it has partnered with AstraZeneca to conduct feasibility studies for a biomarker program that may help the drug developer in preclinical and clinical cancer drug studies.
EpiStem’s so-called “plucked hair” approach is a biomarker program based on a “link between the stem cells in the small intestine and the hair follicle,” the company said. The biomarker now has been developed into “a non-invasive tool to measure drug effects on adult epithelial stem cells and tissues.”
The technology analyzes changes in gene expression that may be found in hairs plucked from human cancer patients in various phases of treatment. These changes can offer researchers information such as the “measure of drug exposure, toxicity, dose/schedule, and patient selection,” the company said.
Because it is non-invasive, the company said, this methodology may be particularly useful in assessing drugs in preclinical development, “thereby assisting go/no go decisions” about drug development and reducing risk and expense of a drug failing in the clinical trial phase.
Brent Vose, AstraZeneca’s vice president of oncology therapies, said minimally invasive biomarkers are “an important step” for their oncology drug programs, and said his company has been “impressed by the plucked hair biomarker technology.”
Jeff Moore, managing director of EpiStem’s novel technologies program, said the US Food and Drug Administration “has made it clear that they want new drugs to have biomarkers that show the direct impact of the drug.”
Moore also said that “at this stage of our development” the company will not make predictions about the program’s commercial value.