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| |  ImClone Systems Initiates Phase Ib/IIa Prostate Cancer Clinical Trials NEW YORK, January 10, 1996 - ImClone Systems Incorporated (Nasdaq: IMCL) today announced the initiation of additional Phase Ib/IIa clinical trials for the Company's lead cancer therapeutic, C225, an epidermal growth factor receptor (EGFr) antagonist. The dose escalation study will evaluate C225 in conjunction with the chemotherapeutic agent Adriamycin in patients suffering from advanced prostate carcinoma. C225 is designed to block the EGF receptor, over-expressed on several varieties of cancer, and in combination with chemotherapy or radiation, to eliminate cancerous cells through a mechanism which is believed to involve the induction of apoptosis, the natural process of cellular death. The multi-site trial will be conducted at Memorial Hospital, the patient care arm of Memorial Sloan-Kettering Cancer Center, and the University of Virginia Cancer Center. The protocol calls for a total of 15 patients to receive C225 and Adriamycin by weekly intravenous administration in a multiple injection dose escalation. A multiple injection, dose escalation Phase Ib/IIa study of C225 is currently being conducted in patients with advanced head and neck, and lung carcinomas. Patients are being treated with C225 in combination with the chemotherapeutic agent cisplatin. The study is scheduled to be completed by the end of the first quarter 1996. Animal studies evaluating the use of C225 activity against human prostate cancer cell lines showed pronounced anti-tumor activity resulting in the complete destruction of the human tumor cells in the experimental model. These experiments have shown long-term tumor-free survival of animals. EGFr is expressed in select normal human tissue and has been shown to be over-expressed on the cells of approximately one-third of all cancers. Antibodies directed against EGFr may inhibit the uncontrolled cancer cell growth that has been shown to be associated with this receptor's activity. Indications for the C225 therapeutic include breast, ovarian, prostate and head and neck cancers. ImClone Systems Incorporated, head-quartered in New York, is a biopharmaceutical company developing novel therapeutic products including interventional therapeutics, blood cell growth factors, and cancer vaccines for the treatment of cancer and cancer-related disorders.
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