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Clinical Trial to Evaluate Antitumor Activity of Epidermal Growth Factor in Breast Cancer

Clinical Trial to Evaluate Antitumor Activity of Epidermal Growth Factor in Breast Cancer

ImClone Systems has initiated an additional phase Ib/IIa clinical trial of C225, the company's epidermal growth factor (EGF)-receptor antagonist. The dose-escalation study will evaluate C225 in conjunction with the chemotherapeutic agent paclitaxel (Taxol) in patients suffering from EGF receptor-positive breast carcinoma. C225 is designed to block the EGF receptor, which is overexpressed in several varieties of cancer. In combination with chemotherapy or radiation, C225 eliminates cancerous cells through a mechanism that is believed to involve the induction of apoptosis, the natural process of cell death.

The multisite trial will be conducted at Memorial Hospital, the patient care arm of Memorial Sloan-Kettering Cancer Center, under the direction of Larry Norton, MD, and at the Yale University School of Medicine, Department of Medicine under the direction of Barbara Burtness, MD. Patients will receive C225 by weekly intravenous administration in a multiple-injection dose-escalation study in combination with paclitaxel.

ImClone recently announced the initiation of a phase Ib/IIa clinical trial to evaluate C225 in conjunction with doxorubicin in patients suffering from advanced prostate carcinoma. In addition, multiple phase Ib/IIa studies of C225 are currently being conducted in patients with advanced head and neck and lung carcinomas. Patients in these studies are being treated with C225 in combination with cisplatin (Platinol).

"The breast cancer study marks the third of our phase Ib/IIa clinical trials of C225 targeting specific tumors in combination with chemotherapeutic agents," said Harlan W. Waksal, MD, Executive Vice President and Chief Operating Officer of ImClone Systems, "The results of these studies will provide valuable safety and pharmacokinetic data regarding C225. Moreover, they will further demonstrate the potential marketing breadth of this product in various cancer indications."

Pronounced Activity Against Breast Cancer Cell Lines

Animal studies evaluating the use of C225 activity against human breast cancer cell lines showed pronounced antitumor activity resulting in the complete destruction of the human tumor cells in the experimental model. These experiments also demonstrated long-term tumor-free survival of the animals.

The EGF receptor is expressed in select normal human tissue and has been shown to be overexpressed in the cells of approximately one-third of all cancers. Antibodies directed against the EGF receptor may inhibit the uncontrolled cancer cell growth that has been shown to be associated with this receptor's activity. Potential indications for C225 include head and neck, lung, breast, prostate, and ovarian cancers.

 
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