updated 6/8/2005 1:17:30 PM ET 2005-06-08T17:17:30

Biotechnology firm ImClone Systems Inc. said Wednesday that data from a late-stage study confirmed that its Erbitux drug, when used in combination with radiation therapy, prevents the spread of head and neck cancer more effectively than radiation therapy alone. Erbitux is already approved by the Food and Drug Administration to treat colorectal cancer.

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The disclosure on Erbitux came a day after ImClone said financier Carl Icahn had filed with antitrust regulators for clearance to invest more than $100 million in the company, including already acquired shares. The filing sets an investment ceiling of $500 million. As of March 15, the billionaire investor owned about 5 million ImClone shares, or close to 6 percent of its outstanding stock.

In the latest announcement on Erbitux, ImClone said overall survival and progression-free survival, secondary endpoints of the Phase III study, showed statistically significant improvements with the addition of Erbitux to radiation.

ImClone said the study was an international, randomized trial that enrolled 424 patients with advanced squamous cell carcinoma of the oropharynx (the area of the throat at the back of the mouth), the larynx (or voice box) or hypopharynx — the cavity at the back of the mouth that opens into the esophagus — that had spread through the head and neck region.

“Head and neck cancer remains a disease with too few treatment options and no new therapeutic product approvals in over a decade,” said Eric K. Rowinsky, chief medical officer of ImClone. “We look forward to discussing the next steps toward a regulatory filing with the FDA.”

According to the American Cancer Society, about 40,000 Americans will be diagnosed with oral, head and neck cancer this year, including cancers of the tongue, mouth, pharynx and larynx. More than 11,000 Americans died from the disease in 2004.

Erbitux is already FDA-approved to treat colorectal cancer alone or in combination with the drug irinotecan.

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