Plucked hair model could help smooth drug development path

By Gareth Macdonald

- Last updated on GMT

Related tags: Epidermal growth factor receptor, Cancer

Epistem claims its “plucked hair biomarker model” provides drugmakers with minimally invasive way monitoring epithelial response to cancer candidates that can significantly reduce development times.

The firm’s approach is to monitor how mRNA expression in hair cells is affected by cancer drugs, or developmental candidates, thereby rapidly identifying any biological changes that occur as a result of treatment.

Epistem’s latest study, which was presented at last week’s American Association of Cancer Research (AACR) meeting in Philadelphia, showed the firm was able to track changes in the expression of genes known to respond to Roche’s epidermal growth factor receptor inhibitor Tarceva (erlotinib) in mice.

In a press statement Lydia Meyer-Turkson, director of Epistem's biomarker division said that the model "provides a simple and effective means of measuring biological response in epithelial tissue. These results provide further support to the clinical relevance of hair as surrogate tissue that is readily accessible in early clinical studies​."

A company spokesperson told Outsourcing-pharma that the model is available to pharmaceutical and biotechnology clients for pre-clinical development on a contractual basis.

She added that Johnson & Johnson (J&J), AstraZeneca and five other of the top drug firms have already used the model for research purposes.

The new data, coupled with Epistem’s earlier use of the model to monitor mRNA expression linked to c-met inhibition in human scalp hairs, indicate that it has application in both preclinical development and clinical trials.

Epistem also stressed that, in the post genomic era, an effective method of monitoring mRNA expression may allow the identification of patient-specific responses to treatment during trial stage development.

A good example of the use of this sort of information is provided by Genentech’s Herceptin (trastuzumab) which is only effective in a relatively small percentage of breast cancer sufferers.

Firms making similar products to Herceptin could use Epistem’s test to quickly establish how big a patient group can be treated by a particular drug candidate and therefore decide whether or not to pursue development at an earlier stage.

In general however, with the cost of development continuing to edge toward the $2bn (€1.5bn) mark the ability to identify effective drug candidates as rapidly as possible is becoming increasingly important.

Epistem’s efficacy model will also attract the interest of pharmaceutical and biotech firms desperate to boost pipelines but that have been forced to cut back on R&D and trial budgets to weather the current economic downturn.

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