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BMS Identifies Response Biomarkers to Erbitux

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Bristol-Myers Squibb, eager to expand the patient population for its targeted colorectal cancer drug Erbitux, is heavily immersed in genomic biomarkers tied to tumor response, according to a company researcher.

Helped by Genomic Health and the drug’s developer, ImClone, the efforts appear to be paying off: The drug maker has recently identified a set of biomarkers that may triple the drug’s response rate through better selection of patients, said Shirin Khambata-Ford, BMS’s senior research investigator for oncology biomarkers.

Khambata-Ford presented her company’s findings during a talk at the Drug Discovery Technology conference this summer. BMS has a program focused on moving Erbitux from third-line therapy to second-line therapy by identifying pharmacogenomic biomarkers of response, she said. And ImClone, the company’s partner, has been trying to broaden the drug’s indication using pharmacogenomics since at least June 2005.

In an interview after her talk, Khambata-Ford declined to disclose development plans for the assay.

BMS prefers to conduct its oncology biomarker programs in parallel with drug discovery and development, Khambata-Ford said. In some cases, the approach can lead to pharmacogenomic programs. This didn’t occur with Erbitux’s response biomarker, however, because the drug has been approved in the US since early 2004. It received its CE Mark in June 2004.

Still, Khambata-Ford explained the firm’s Erbitux program in the context of BMS’s oncology biomarker discovery and development efforts. If her presentation is an accurate guide, that effort has been largely genomic.

According to the US Food and Drug Administration, Erbitux is the first monoclonal antibody approved to treat metastatic colorectal cancer and is indicated as a combination treatment with irinotecan or as a standalone drug if patients cannot tolerate irinotecan.

The BMS researcher team is supporting its biomarker focus with biopsy samples, archival tissues, and blood samples in a phase 2 exploratory study of Erbitux monotherapy in refractory metastatic colorectal cancer.

— Chris Womack

PATENT WATCH

US Patent 7,083,921. Method to determine the risk for side effects of SSRI treatment. Inventors: Greer Murphy and Alan Schatzberg. Assignee: Stanford University. Issued: August 1, 2006. This invention provides a new method found to determine an increased risk for side effects in an individual treated with SSRIs. The method covers genotyping an individual for the presence of the 102 C/C DNA sequence in the 5-HT2A receptor gene. The abstract also includes mention of a method to improve treatment of SSRI-responsive disorders, particularly in cases of depression.

US Patent 7,101,670. Polymorphic marker that can be used to assess the efficacy of interferon therapy. Inventors: Noriko Matsuyama, Masanobu Sugimoto, Michie Hashimoto, and Shunji Mishiro. Assignee: Kabushiki Kaisha Toshiba. Issued: September 5, 2006. This invention covers a polymorphic marker found in a region of the interferon receptor gene that can be used to assess the efficacy of interferon therapy. The invention also relates to methods of assessing the efficacy of interferon therapy in an individual, as well as means for putting such methods into practice.

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DATAPOINT

$3.3 million

Amount awarded by the US National Institute of Allergy and Infectious Disease to Cepheid to further develop its Mycobacterium tuberculosis diagnostic detection and drug response prediction test.

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