ImClone shares gain on positive review data for Erbitux - update 3

06/09/05 - newratings.com

NEW YORK, June 9 (newratings.com) – The share price of ImClone Systems Inc (IMCL) appreciated almost 17% on Wednesday, after the company disclosed positive clinical trial data for its cancer drug, Erbitux.

The US-based biotechnology company said in a statement on Wednesday that the results from an independent review of the late-stage clinical trial have confirmed that Erbitux helps in head and neck cancer treatments. According to the study results, the company's Erbitux drug, when used in combination with radiation therapy, prevents the spread of head and neck cancer more effectively than treatment by radiation therapy alone, the statement added. The US Food and Drug Administration (FDA) has already approved Erbitux for the treatment of colorectal cancer. ImClone plans to hold discussions with the FDA regarding additional measures to be taken before applying for the approval of Erbitux in the treatment of head and neck cancers, the company said on Wednesday. Earlier this year, ImClone said that it is postponing its application for approval of Erbitux in treatment of head and neck cancer until late this year, as compared to the previous forecast for 2Q05. Previously, ImClone Systems' Erbitux drug was at the center of a scandal that once led to prison terms for the company's founder, Sam Waksal, and lifestyle celebrity, Martha Stewart. Both Sam Waksal and Martha Stewart had sold their shares in ImClone in December 2001, before it was publicly disclosed that the company's application for the approval of Erbitux was being rejected by the FDA.