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Clinical Trial Underway for Cancer Stem Cell Therapy

Chemotherapy (National Institutes of Health)

(National Institutes of Health)

OncoMed Pharmaceuticals Inc., a biotechnology company in Redwood City, California, began dosing patients enrolled in a clinical trial of its therapy addressing cancer stem cells. The phase 1 trial is testing OMP-52M51, a monoclonal antibody — a type of engineered antibody molecule — designed for patients with hematologic cancers, in this case lymphoid malignancies.

Cancer stem cells are a type of tumor cells that can self-renew, and drive the production and metastasis of tumors. Common cancer drugs target ordinary tumor cells, says OncoMed, but have only a limited effect on cancer stem cells, which provides an opportunity for the tumor to recur. OncoMed says its product candidates block the self-renewal and differentiation of cancer stem cells, driving the cancer stem cells to a non-tumor state.

The clinical trial plans to enroll 53 patients at five sites in the U.S., including the Sarah Cannon Research Institute in Nashville where the first patient was enrolled. Participants in the trial are adults with malignant lymphoid cancer, who have either relapsed or have not responded to treatments.

The open-label trial is using escalating doses of OMP-52M51, looking particularly for safety, interaction between the drug and bodily functions, and first signs of efficacy. The trial is also testing a patient-selection procedure based on biomarkers.

OMP-52M51 is part of a collaboration with GlaxoSmithKline that began in December 2007. GSK retains an option through the end of certain phase 1 or phase 2 clinical trials to obtain an exclusive license to OMP-52M51. OncoMed says the enrollment of the first patient in this trial triggers a a $4 million milestone payment from GSK.

OMP-52M51 is the company’s fifth anti-cancer therapy in clinical trials. OncoMed says it also plans to file an investigational new drug application with the FDA to test OMP-52M51 in patients with solid tumors.

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