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...

To continue reading