Additional Erbitux Benefits Seen

Biotechnology firm ImClone Systems Inc. said Wednesday that a late-stage study confirmed that Erbitux is effective in preventing the spread of head and neck cancer.

The announcement 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. Separately, ImClone withdrew a proposed stock incentive plan because a number of holders expressed concern about the program's dilutive affect on shares.

Erbitux, already approved as a treatment for colorectal cancer, is the drug at the center of the scandal that lead Martha Stewart and ImClone's founder Sam Waksal to prison. Both Stewart and Waksal dumped ImClone shares in December 2001 before it became public that the U.S. Food and Drug Administration was rejecting the company's application for the Erbitux's approval. The rejection sent ImClone shares into a tailspin.

Stewart was convicted for lying about the stock sale and was released from prison last March. Waksal pleaded guilty to insider trading charges and remains incarcerated.

In the latest announcement, ImClone said data showed that when Erbitux is used in combination with radiation therapy, it prevents the spread of head and neck cancer more effectively than radiation therapy alone.

ImClone said the 424-patient study tested Erbitux in 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 throat, pharynx and larynx. More than 11,000 Americans died from the disease in 2004.