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New Biomarkers Predict Response for Velcade

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Millennium Pharmaceuticals has discovered biomarkers that may identify likely responders to its multiple myeloma drug Velcade, and hopes that additional pharmacogenomic research will help improve outcomes and expand use of the drug into a broader multiple myeloma patient population.

Genomic analyses on tumor samples prospectively collected from previously treated multiple myeloma patients revealed that patients with an increased expression of genes in the NF-kB  and adhesion molecule pathways may be more sensitive to the drug.

Additionally, Millennium identified gene-based predictive and survival classifiers that need further validation. The results from Millennium’s analyses appear in the April 15 issue of Blood.

The US Food and Drug Administration approved Velcade in 2003 to treat patients whose myeloma has relapsed after two prior therapies. It is the first proteasome inhibitor to win FDA approval.

George Mulligan, associate director of oncology clinical development at Millennium, says that the company is currently focused on conducting genome-based clinical trials to identify patients who will respond to Velcade as a single agent or in combination with other therapies. But, he adds, the research is too preliminary to determine if a molecular diagnostic would optimize treatment.

Millennium conducted the research in collaboration with the Dana-Farber Cancer Institute, the Myeloma Institute of Research and Therapy at the University of Arkansas for Medical Services, the Mayo Clinic, and the Department of Hematology at Erasmus Medical Center.

In the past, retrospective gene-expression analysis has been able to pinpoint tumor sensitivity to certain cancer therapies. However, Millennium’s pharmacogenomic goal with Velcade was to collect genetic samples prospectively and link gene expression with the proteasome inhibitor’s activity.

“Doing prospective work as part of clinical trials is necessary for this research to reach its full potential,” Mulligan says. 

Velcade co-developers Millennium and Johnson & Johnson will conduct genomic analyses in combination with other cancer agents to explore optimal treatment strategies. 

Turna Ray

Short Reads

Florida Atlantic University and Torrey Pines Institute for Molecular Studies plan to study compounds discovered by TPIMS with an FAU genetic discovery related to three major cancers. Under the agreement, FAU and TPIMS will use a gene called SIM2, which has been associated with colon, prostate, and pancreatic cancers, at FAU’s Charles E. Schmidt College of Science to develop drugs.

DiagnoCure plans to develop and sell two molecular diagnostic tests for cancer that it licensed from Targeted Diagnostics and Therapeutics. The tests are designed to detect guanylyl cyclase C, which seems to be found outside the intestine only when colorectal cancer has metastasized. Under the agreement, Quebec-based DiagnoCure will develop the tests as home-brew ASRs in TDT’s CLIA-certified lab.

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Patents

US Patent 7,211,387. DNA molecule encoding a variant paraoxonase and uses thereof. Inventors: Jukka Salonen, Marja Marchesani, Tomi-Pekka Tuomainen, and Jari Kaikkonen. Assignee: OY Jurilab. Issued: May 1, 2007.

This patent covers a DNA sequence that encodes a variant paraoxonase protein as well as a method and kit “for detecting a risk of cancer, coronary or cerebrovascular disease, hypertension, type 2 diabetes, dementia, joint arthrosis, cataract, or sensitivity to organophosphorus compounds” in a patient.

US Patent 7,208,273. Common polymorphism in scn5a implicated in drug-induced cardiac arrhythmia. Inventors: Mark Keating and Igor Splawski. Assignee: University of Utah Research Foundation. Issued: April 24, 2007.

The invention relates to “a specific mutation in SCN5A which causes drug-induced torsade de pointes or ventricular fibrillation,” according to the abstract. The patent includes a way to diagnose people with the mutation and to test drugs to determine whether they will cause these conditions.

Data Points

22,000

The University of Massachusetts Dartmouth just opened a new research facility to house the National Botulinum Center. The 22,000-square-foot facility will be home to work involving genomics, bioinformatics, enzyme studies, cellular trafficking, and structural biology research.

The Scan

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CRISPR for What Ails You

The Wall Street Journal writes that CRISPR-based therapies could someday be used to treat common conditions like heart attacks.

Nature Papers Review Integration of Single-Cell Assay Data, Present Approach to Detect Rare Variants

In Nature this week: review of ways to integrate data from single-cell assays, and more.