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Clinical Data, OncoMethylome, Schering-Plough, NIEHS, Mayo Clinic, Orion, Tm Bioscience

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Clinical Data to Develop Dx to Predict Response Rate for Rituximab
 
Clinical Data plans to develop a molecular diagnostic aimed at identifying patients likely to respond to a monoclonal antibody made by Genentech/Biogen-Idec and Roche
 
The deal calls for Clinical Data to measure patient response to rituximab, which is used to treat non-Hodgkins lymphoma and rheumatoid arthritis. The company said last week that it has signed a licensing agreement for “an extensive portfolio of patents” toward this goal, but would not disclose the name of the licenser.
 
Clinical Data said the diagnostic will employ a variation in the FCGRIIIA gene, which will have a greater than 90-percent specificity in predicting response to rituximab in NHL.
 
The company also expects that this gene will be useful in measuring response to other monoclonal antibodies used to treat Crohn’s disease and other inflammatory disorders.
 
Genentech recently licensed a gene map of Crohn’s disease from Genizon Biosciences.
 
Clinical Data said it expects to begin working on the rituximab diagnostic in early 2007.
 

 
OncoMethylome Expands MGMT Methylation Agreement with Schering-Plough
 
OncoMethylome Sciences said this week that it has extended an existing agreement with Schering-Plough to provide methylation testing in clinical trials focused on brain cancer and other cancers.
 
The agreement applies to OncoMethylome’s methylation assay for the MGMT biomarker, which has been shown to be methylated in a number of cancer types.
 
The company currently provides its MGMT methylation service for Schering-Plough for a multi-center clinical trial that is evaluating whether brain tumor patients can benefit from a more intensive temozolomide drug treatment regimen.
 
Under the terms of the new agreement, OncoMethylome’s assay will be used for MGMT methylation testing in “multiple national and international clinical trials” involving temozolomide in brain cancer and other cancers, the company said.
 

 
NIEHS Releases SNP Data for 15 Mouse Strains
 
Researchers have sequenced the DNA of 15 mouse strains that are commonly used in biomedical research, the National Institutes of Health said this week.
 
The National Institute of Environmental Health Sciences contracted Perlegen Sciences to complete the work, which has produced data that will "help researchers better understand what makes some individuals more susceptible than others to certain diseases," NIEHS said in a statement
 
The NIEHS also plans to use these data to determine how substances in the environment are linked to disease.
 
The data, which includes more than 8.3 million SNPs, is available through the National Center for Biotechnology Information website.
 

 
Mayo Clinic and Orion to Validate Breast Cancer Biomarkers
 
Orion Genomics will work with researchers at the Mayo Clinic to validate the company’s breast cancer screening technology in a clinical environment.
 
Orion will use its epigenetic biomarker-based technology with physicians at Mayo Clinic’s Department of Laboratory Medicine and Pathology to analyze cross-reactivity in more than a dozen types of breast cancer.
 
With epigenetic biomarkers, Orion said, it is developing tests to work in various tissues to enhance the capacity for early detection.
 
Its MethylScope platform can detect “methylation status of each and every human gene,” the company said, adding that it has already discovered more than 50 breast cancer biomarkers.
 
Orion has recently used its methylation platform to screen for colon cancer, cervical cancer, and other diseases at Washington University and at Johns Hopkins University Hospital.
 

 
Tm Bioscience Defers by One Year $2M Payment to Sirius in Biomarker Agreement
 
Tm Bioscience said last week that it has amended its licensing agreement with Sirius Genomics to defer a $2 million payment that was due Sept. 5 until sometime in October 2007, or “90 days after completion of certain milestones by Sirius.”
 
Tm Bioscience’s patented materials include an FDA approved genotyping test for cystic fibrosis, as well as other tests based on the company’s Tag-it Universal Array platform.
 
Sirius works to identify biological pathways that may help to improve study design and assist in the selection of candidates for clinical trials.
 
The agreement deals with diagnosis concerning protein C and arginine vasopressin.

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