ImClone Achieves Milestone Related to International Development of IMC-C225
NEW YORK--(BW HealthWire)--March 15, 2000--
Achievement of Clinical Milestone Triggers $2 Million Payment to
Be Received from Partner, Merck KGaA
ImClone Systems Incorporated (Nasdaq: IMCL) announced today it has achieved a clinical milestone in its IMC-C225 development and commercialization agreement with Merck KGaA for territories outside of North America. The milestone relates to the expansion into France of Merck KGaA's Phase II study of combination IMC-C225 and cisplatin in patients with refractory advanced squamous cell head and neck carcinoma. ImClone also announced that it would receive a $2 million payment from Merck KGaA for the achievement of this milestone.
"We are pleased with the rapid expansion of Merck KGaA's Phase II study into France. The trial expansion is a testament to Merck KGaA's commitment to the international development of IMC-C225 and, as always, ImClone will work with them, providing any assistance necessary toward meeting that goal," stated Samuel D. Waksal, Ph.D., President and Chief Executive Officer of ImClone Systems Incorporated.
IMC-C225, ImClone's lead biologic cancer therapeutic, is being developed to treat cancers that are positive for the epidermal growth factor receptor (EGFr), associated with tumor cell growth in a number of solid tumor cancers. The Company is conducting two Phase III clinical trials evaluating IMC-C225 in combination with radiotherapy and with chemotherapy in patients with advanced squamous cell head and neck carcinoma. Additionally, ImClone is conducting a Phase II trial evaluating IMC-C225 in combination with cisplatin in patients with refractory advanced squamous cell head and neck carcinoma, and a second Phase II trial evaluating IMC-C225 in combination with irinotecan in patients with refractory colorectal carcinoma. Also underway is a Phase II study evaluating IMC-C225 in combination with the anti-cancer agent gemcitabine in patients with pancreatic cancer.
In addition to IMC-C225, ImClone's other late stage clinical development program is an anti-cancer vaccine, BEC2. In May 1998, ImClone and its corporate partner Merck KGaA initiated a Phase III multi-national clinical trial in patients with limited disease small cell lung cancer.
ImClone is also evaluating the therapeutic potential of its angiogenesis inhibitor, IMC-1C11, an anti-KDR monoclonal antibody which targets tumors known to secrete vascular endothelial growth factor (VEGF). In December 1999, ImClone filed an Investigational New Drug application with the U.S. Food and Drug Administration to initiate Phase I clinical testing of its anti-angiogenesis agent.
ImClone Systems Incorporated is advancing oncology care by developing a portfolio of targeted biologic treatments, which address the unmet medical needs of patients with a variety of cancers. The Company's three programs include growth factor blockers, cancer vaccines and anti-angiogenesis therapeutics. ImClone's strategy is to become a fully integrated biopharmaceutical company, taking its development programs from the research stage to the market. ImClone is headquartered in New York City with manufacturing facilities in Somerville, New Jersey.
Except for the historical information contained herein, the matters discussed in this news release may include forward-looking statements. Actual results may differ materially from those predicted in such forward-looking statements due to the risks and uncertainties inherent in the Company's business, including, without limitation, risks and uncertainties in obtaining and maintaining regulatory approval, market acceptance of and continuing demand for the Company's products, the impact of competitive products and pricing, and the Company's ability to obtain additional financing to support its operations. The Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
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