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More Big-name Pharma Firms Join NCATS Therapeutic Repurposing Effort

NEW YORK (GenomeWeb News) – The National Center for Advancing Translational Sciences said today that five additional pharmaceutical companies have joined its new program to enable researchers to study new uses for chemical compounds that have been set aside by drug makers

The five new participants in the NCATS program are Abbott, Bristol-Myers Squibb, GlaxoSmithKline, Janssen Pharmaceutical Research and Development, and Sanofi.

NCATS also today published two new funding announcements and a pre-application notice for researchers seeking some of the $20 million it has set aside for the program for next year.

The goal of NCATS' Discovering New Therapeutic Uses for Existing Molecules program is to fund research that will crowdsource compounds that have already been well developed by drug makers, and have been safety tested in humans, but which did not work for their intended purposes.

The new group of drug developers joins Pfizer, AstraZeneca, and Eli Lilly in providing compounds for the program, which NCATS launched last month, and boosts the number of compounds available for study to nearly 60, NCATS said. In announcing the program in May, NIH Director Francis Collins said that in the pilot phase the program will match US researchers with compounds to explore how the compounds could be used for new purposes.

NCATS already has posted preliminary information about these compounds, including mechanism of action, route of administration, and any limitations in use based on safety and tolerability.

"Each company participating in this innovative collaboration has made substantial research and development investments to advance these compounds to the point where they can be used in clinical studies," NCATS Acting Deputy Director Kathy Hudson, said in a statement. "If researchers funded through this effort can demonstrate new uses for the compounds, they could significantly reduce the amount of time it takes to get a treatment to patients in need."

The $20 million that NCATS plans to award in 2013 will support staged cooperative agreement research grants that could lead to pre-clinical validation and clinical feasibility studies in the first stage, and proof-of-concept clinical trials in the second stage to test whether the compounds may work against a new target.

According to the funding new announcements, in the first stage of these projects, investigators may consider using pharmacokinetic and pharmacodynamic biomarkers to assess the selection of doses and exposure of the compounds. In the second stage, researchers also may include molecular markers of disease, pharmacogenomics approaches, or other biomarkers to develop patient selection strategies for the clinical trials.

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