NEW YORK (GenomeWeb News) — The US Food and Drug Administration has approved the first phase of a BG Medicine and National Center for Toxicological Research project to develop biomarkers for liver toxicity, BG Medicine said today.
The company also said it will use mass spectrometry technology made by Applied Biosystems, and has named seven pharmaceutical companies that will participate in the project.
The goal of the project is to seek biomarkers of hepatotoxicity in humans in a standard preclinical pharmaceutical test.
BG Medicine said the project will be conducted under a Cooperative Research and Development Agreement and is part of the larger Critical Path Initiative, which the FDA inaugurated in 2004 as a response to what it called an “urgent need” to modernize and bring down the cost of medical products development.
BG Medicine said it expects phase one will last around nine months.
Pharmaceutical companies working with and helping to fund the biomarker project include Pfizer, Johnson & Johnson Pharmaceutical Research and Development, Mitsubishi Chemical Holdings, Orion, UCB, Sankyo, and Eisai.
BG Medicine submitted the CRADA with the FDA's NCTR in 2005. At the time, the company said that it has jointly designed the study with the FDA "with input from a number of pharmaceutical companies."
BG Medicine had said that the study will be funded by pharmaceutical manufacturers, who will receive "a paid-up perpetual license to any biomarkers discovered and access to all project data."
The study will be conducted at the FDA's NCTR laboratory in Jefferson, Ark., and at BG Medicine’s facility in Waltham, Mass., where the organizations will rely on a range of technologies, including functional genomics, proteomics, metabolomics, and computational analysis.
BG Medicine said it expects the project to result in improved tests for liver toxicity, which is the most common biological reason for drug failure.
Current toxicity testing methods "often fail to identify human liver toxicity issues," the company said. "Consequently, liver toxicity is often detected for the first time when drugs are in phase II of clinical testing after tens of millions of dollars or more have been spent on a drug."