Medarex Inc. is starting its first clinical trial with its second- generation cancer therapeutic that links tumor and immune cells.

The Phase I/II trial of 40 patients with demonstrated resistance to conventional treatments for breast or ovarian cancer is taking place at Dartmouth-Hitchcock Medical Center in Lebanon, N.H.

The company's compound, MDX-210, combines fragments of monoclonal antibodies (MAbs) to specific components of immune cells and a protein that is produced in abundance of the surface of some cancer cells, HER-2.

This "bispecific" approach is intended to kill cancer cells by anchoring them to such white blood cells as monocytes, macrophages and neutrophils via the immune cells' Fc receptors, components that have been demonstrated to play a key role in mediating destruction of tumor cells and foreign pathogens.

The trial is being headed by Frank Valone, associate professor of Medicine at Dartmouth Medical School, who said the treatment represents a "promising" adjunct therapy for removing residual tumor cells.

Donald Drakeman, president and chief executive officer of the Princeton, N.J., company (NASDAQ:MEDX), said he expects the next bispecific product in the clinic to be a compound currently in preclinical testing against HIV. The company is also working with the Curie Institute in Paris on a bispecific compound against melanoma, and is in Phase I/II and II trials with first- generation monoclonal antibodies against acute myeloid leukemia. These MAbs are intended to trigger blood plasma components called "complement" to burst the cancerous cells apart.

Breast cancer is expected to be diagnosed in 183,000 Americans this year, while the American Cancer Society predicts 22,000 new cases of ovarian cancer, which is the leading cause of death among cancers of the female reproductive system.

Although the trial is targeting these two indications, the HER-2 protein also exists in excess in colon, lung and gastric cancers.

-- Nancy Garcia Associate Editor

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