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Roche AmpliChip to Help Merck Investigate Role of p53 DNA Damage in Cancer Rx Response


By Turna Ray

This article was originally posted on Feb. 23.

Roche Molecular Systems and Merck have inked a pharmacogenomic research collaboration to learn how the tumor suppressor protein p53 impacts cancer patients' resistance to certain drugs in Merck's pipeline.

Merck subsidiary Merck Sharp & Dohme will use Roche's investigational AmpliChip p53 test in clinical studies to assess which cancer patients are likely to respond to drugs that are currently in development. "The goal of our research is to discover and develop innovative cancer therapeutics and deliver them to the right patients at the right time," Eric Rubin, VP of Oncology at Merck Research Laboratories, said in a statement.

Roche designed the AmpliChip p53 test to "rapidly provide clinically important information that can be used early in pharmaceutical development to help predict cancer patient responses to certain therapeutic candidates," Paul Brown, CEO of Roche Molecular Diagnostics, said in a statement.

The p53 protein activates a cell's DNA repair mechanisms, but when it is damaged it compromises the ability to repair DNA, which can diminish a tumor cell's response to chemotherapy and lead to tumor growth. Combining PCR and a microarray-based platform, the AmpliChip p53 test may be able to determine which patients are most likely to be unresponsive to certain treatments by detecting damage to p53 DNA in tumor cells.

The test "is intended for investigational use as a companion diagnostic test in cancer clinical trials," a Roche spokesperson told Pharmacogenomics Reporter this week. "Until we’ve gained additional information from the clinical trials, it’s too soon to say how long the collaboration might last or when or how we might commercialize the product."

Roche's ongoing work to study the role of p53 in cancer was likely the big draw for Merck in this collaboration. According to a Roche spokesperson, the company is studying its AmpliChip p53 test in an MDM2 inhibitor program.

MDM2, or murine double minute 2, proteins play a role in regulating p53 proteins. When gene mutations or environmental factors affect the functioning of MDM2 or p53 proteins, they may foster tumor progression. By using the AmpliChip p53 test in its investigational MDM2 inhibitor program, "Roche intends to gain a deeper understanding of how new therapeutics in development in this area can better meet the needs of cancer patients," the Roche spokesperson said.

A Merck spokesperson said that the company is not ready to announce which specific drugs in its pipeline are being used in the p53 studies. However, Merck's pipeline, posted on its website, reveals several oncologics currently in development.

Dinaciclib is an oncologic currently in Phase II development at Merck. According to the National Cancer Institute's clinical trials database, researchers at the Dana-Farber Cancer Institute plan to conduct a Phase I/II study with dinaciclib to investigate the side effects and best dose of the drug in stage II and stage IV malignant melanoma patients whose tumors cannot be removed with surgery. One of the secondary endpoints of the study is to correlate tumor p53 status with clinical outcome.

Merck also has in Phase II studies a cell cycle checkpoint 1 kinase inhibitor. The p53 protein has been shown in published studies to influence the activity of certain CHK-1 inhibitors.

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