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IMCLONE ACHIEVES PATIENT ENROLLMENT MILESTONE IN TRIAL.

ImClone Systems Incorporated (Nasdaq: IMCL), New York, has achieved a patient enrollment milestone in its agreement with Merck KGaA for the company's investigational cancer vaccine candidate BEC2. The milestone, which triggers a $500,000 payment, relates to reaching the halfway mark in study enrollment in its multinational Phase III clinical trial of BEC2 in patients with limited disease small cell lung carcinoma. Merck KGaA is the company's co-promotion partner for BEC2 in the United States and is co-sponsoring the Phase III clinical trial. BEC2, the company's lead cancer vaccine candidate, is an investigational anti-idiotypic monoclonal antibody designed to prevent or delay the recurrence of certain types of tumors, such as small cell lung carcinoma. By mimicking the GD3 tumor-associated antigen, BEC2 appears to stimulate a stronger immune response than natural GD3.

"Cancer vaccines continue to represent one of the most promising new biologic approaches to cancer treatment. As ImClone Systems has pioneered research in this area, the attainment of this milestone in the BEC2 program is a significant event for the company," stated Samuel D. Waksal, Ph.D., president and CEO of ImClone Systems Incorporated. " As we continue to enroll patients in our pivotal clinical trial of BEC2, we are also preparing additional vaccine candidates to enter the clinic, including our gp75 melanoma vaccine candidate."

Also in late stage clinical studies is IMC-C225, ImClone Systems' lead investigational cancer therapeutic. IMC-C225 is an investigational monoclonal antibody designed to target and block the Epidermal Growth Factor Receptor (EGFR), which is expressed on the surface of cancer cells. ImClone Systems is studying IMC-C225 in a series of Phase II and Phase III clinical trials. The company is conducting Phase II studies of IMC-C225 in combination with standard therapies in refractory colorectal carcinoma and refractory head and neck carcinoma, pancreatic carcinoma and non-small cell lung carcinoma. In addition to the Phase II studies, the company is conducting a Phase III clinical trial of IMC-C225 in combination with chemotherapy and another study combining IMC-C225 with radiotherapy for evaluation as first line treatments for head and neck carcinoma. Under the terms of a 1998 agreement, Merck KGaA has been granted a license from the company to rights to IMC-C225 outside of North America, with the exception of Japan, where the companies will co-develop the drug.

ImClone Systems is also evaluating the therapeutic potential of IMC-1C11, its lead angiogenesis inhibitor. IMC-1C11 is an investigational monoclonal antibody designed to target and block the Vascular Endothelial Growth Factor Receptor (VEGFR) known as KDR, on the surface of growing endothelial cells. By blocking KDR, IMC-1C11 is believed to prevent tumor growth by inhibiting new blood vessel formation into the tumor. The company is conducting a Phase I clinical study to evaluate the safety and pharmacokinetics of IMC-1C11 in patients with metastatic colorectal carcinoma.

ImClone Systems Incorporated is committed to advancing oncology care by developing a portfolio of targeted biologic treatments, which address the needs of patients with a variety of cancers. The company's three programs include growth factor blockers, cancer vaccines and angiogenisis inhibitors. ImClone Systems' strategy is to become a fully integrated biopharmaceutical company, taking its development programs from the research stage to the market. ImClone Systems is headquartered in New York City with manufacturing facilities in Somerville, New Jersey.

For more information, call 646/638-5058.
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Publication:Biotech Business
Date:Jun 1, 2001
Words:547
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