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Iconix Pledges Public Release of Genomic Biomarker Data

NEW YORK, March 23 (GenomeWeb News) - Iconix Pharmaceuticals said today that it would publicly release a subset of its proprietary genomic biomarker data - a move that supports the US Food and Drug Administration's ongoing pharmacogenomics initiative, the company said.

At the 43rd Annual Society of Toxicology Meeting in Baltimore, Md., today, Iconix said it would provide "immediate early access" to five of its Drug Signature gene-expression biomarkers "to qualified researchers and organizations who agree to make their findings publicly available in support of the program."

Iconix said it plans to publish its own findings on the derivation, validation, and application of its genomic biomarkers in "leading peer-reviewed journals" later this year.

The new initiative is designed "to make a greater body of evidence available to researchers in support of the FDA initiative to finalize guidelines on the use of pharmacogenomic data in regulatory decision-making," the company said. In particular, Iconix said it intends to "stimulate increased public dialogue and research on the definition and application of 'Known Valid Biomarkers'" -- a concept still being developed by the FDA.

Iconix said that it has derived and validated hundreds of Drug Signatures, which it uses to predict the potential toxicity, mechanism, or side effects of a drug candidate. The five biomarkers selected for the research initiative were selected based their "relevance to a broad cross-section of the scientific community and targeted at key drug-induced toxicities in liver, kidney, and heart tissue that are often cited as the reason for failed drug development programs," the company said.

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