By Brady Huggett

ImClone Systems Inc. began the process of filing a rolling biologics license application with the FDA for approval of its product, IMC-C225, in combination with irinotecan to treat irinotecan-refractory colorectal cancer that is positive for epidermal growth factor receptor.

¿This was an extraordinary opportunity for us,¿ said ImClone¿s chief operating officer, Harlan Waksal. ¿We met the timelines we set for ourselves, and we far surpassed the endpoints we thought we would need to meet to go forward for approval.¿

The rolling application is allowed for drug candidates that have been designated fast-track status. ImClone can submit sections of the BLA on an ongoing basis if certain criteria are met. The FDA granted ImClone fast-track status in February for IMC-C225 for the treatment of irinotecan-refractory colorectal cancer.

Waksal said the company anticipates filing all sections of the rolling BLA to the FDA in four or five months.

IMC-C225 is a monoclonal antibody designed to target and block epidermal growth factor receptor, expressed on the surface of certain cancer cells. IMC-C225 is being studied in Phase II trials in combination with standard therapies in patients with various stages of colorectal cancer, pancreatic cancer, head and neck cancer and non-small-cell lung cancer. Also, ImClone is conducting a Phase III trial combining IMC-C225 with chemotherapy and a Phase III combining the product with radiotherapy as first-line treatments for head and neck cancer.

ImClone presented data from three Phase II trials ¿ for pancreatic, head and neck and colorectal cancers ¿ evaluating IMC-C225 and standard chemotherapies, at the American Society of Clinical Oncology meeting in San Francisco in mid-May. The colorectal cancer trial showed 22.5 percent of patients achieved a partial response. (See BioWorld Today, May 15, 2001.)

Waksal said ImClone would use safety data from all of its trials in the rolling BLA, and efficacy data from work completed in refractory colorectal cancer. If the BLA is approved, ImClone will next look to file for head and neck cancer. There are plans to initiate to initiate Phase III studies for colorectal cancer. The drug could have applications across a range of cancer types, Waksal said.

An advantage of the drug, he said, is that it targets a receptor rather than a tumor. ¿So we are taking one tumor at a time, and we plan to do that for all solid tumor types.¿

ImClone¿s stock (NASDAQ:IMCL) rose $2.32 Thursday to close at $49.70.

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