NEW YORK--(BUSINESS WIRE)--Jan. 5, 2005--ImClone Systems Incorporated (NASDAQ: IMCL) today announced the commencement of patient treatment in a Phase I clinical trial of its fully human monoclonal antibody targeting the vascular endothelial growth factor receptor-2 (VEGFR-2), IMC-1121B, in patients with solid tumors. The Company received approval to begin the trial from the U.S. Food and Drug Administration after reviewing the Company's Investigational New Drug (IND) application.
The two-center study will be conducted at Fox Chase Cancer Center and the University of Colorado Health Sciences Center, and is designed to evaluate the safety and pharmacology of IMC-1121B administered weekly by intravenous infusion. The trial is expected to enroll 33 patients.
IMC-1121B is a fully human monoclonal antibody that is designed to bind to the VEGFR-2 found on tumor vasculature, thereby inhibiting certain ligands known as vascular endothelial growth factors from binding to and activating the receptor. This action blocks a signaling pathway key to new blood vessel formation in growing tumors, which has been shown to starve tumors of their nutrient supply and result in significant tumor growth inhibition in pre-clinical models.
"ImClone Systems continues to bring new product candidates into clinical testing with the hope of understanding the mechanisms responsible for malignant growth and metastasis of various human tumors," stated Daniel S. Lynch, Chief Executive Officer of ImClone Systems. "IMC-1121B targets an important angiogenesis pathway that has proven to be critical for both tumor growth and metastasis, but does so by targeting the receptor that receives the growth signal from the ligands, rather than the ligands themselves. We believe our approach has significant potential in the effective treatment of various human malignant diseases where pathological angiogenesis is involved."
ImClone Systems recently announced that it has received U.S. Patent No. 6,811,779 from the United States Patent and Trademark Office covering the therapeutic use of a vascular endothelial growth factor receptor (VEGFR) antibody and either radiation or a chemotherapeutic agent for use in the treatment of cancer. Such combination use with IMC-1121B would be covered under this patent.
About ImClone Systems Incorporated
ImClone Systems Incorporated is committed to advancing oncology care by developing and commercializing a portfolio of targeted biologic treatments designed to address the medical needs of patients with a variety of cancers. The Company's three programs include growth factor blockers, angiogenesis inhibitors and cancer vaccines. ImClone Systems' strategy is to become a fully integrated biopharmaceutical company, taking its development programs from the research stage to the market. ImClone Systems' headquarters and research operations are located in New York City, with additional administration and manufacturing facilities in Branchburg, New Jersey.
Certain matters discussed in this news release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions it can give no assurance that its expectations will be achieved. Forward-looking information is subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected. Many of these factors are beyond the company's ability to control or predict. Important factors that may cause actual results to differ materially and could impact the company and the statements contained in this news release can be found in the company's filings with the Securities and Exchange Commission including quarterly reports on Form 10-Q, current reports on Form 8-K and annual reports on Form 10-K. For forward-looking statements in this news release, the company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise.
CONTACT: ImClone Systems Incorporated Investors: Andrea F. Rabney or Stefania Bethlen 646-638-5058 Media: David M. F. Pitts, 646-638-5058
SOURCE: ImClone Systems Incorporated
