By Randall Osborne
West Coast Editor
With a lead cancer product targeting the epidermal growth factor receptor, ImClone Systems Inc. is making a move designed to boost the firm's own growth factor: filing a shelf registration for 6 million shares, worth $373.87 million, at Thursday's closing price of $62.312.
"We did it for the flexibility," said Andrea Rabney, spokeswoman for New York-based ImClone, noting the increased number of such filings lately. No decision has been made regarding how many shares might be sold, she said.
"We just split, so we have about 63.6 million [shares] outstanding," Rabney said.
The company's stock (NASDAQ:IMCL) fell $2.875 Thursday to close at $59.437.
The cancer compound, C225, is a chimeric monoclonal antibody. Because the epidermal growth factor receptor is overexpressed on the cells of more than a third of solid tumors, the drug may inhibit tumor growth. In Phase II/III studies, ImClone is focused on renal cell and head and neck carcinoma.
This week, the company disclosed favorable preliminary results, showing tumor shrinkage and slowed disease progression, from an open-label Phase II study of C225 and irinotecan in patients with irinotecan-refractory colorectal carcinoma.
"That's a potential registration study," Rabney said. "We met with the FDA and discussed the endpoints, and we're preparing the data for review."
A similar Phase II study is under way in head and neck cancer, with enrollment expected to complete in the first quarter of next year, she said. Based on talks with the FDA, that study also is a potential registration study, and two more Phase III trials are in progress with C225 in head and neck cancer, expected to finish at the end of next year, Rabney said.
In pancreatic cancer, a Phase II trial is enrolled, and ImClone data will be presented at a scientific forum next year.
ImClone's cancer vaccine, BEC2, is a monoclonal anti-idiotypic antibody that stimulates the immune system against tumors. BEC2 has proven to boost survival rates in small-cell lung carcinoma subjects, and a multinational Phase III trial is under way, Rabney said.
The company also is investigating angiogenesis - specifically, developing monoclonal antibodies that target KDR, the receptor for vascular endothelial growth factor, which has proven to be critical in blood vessel formation. ImClone aims to find ways to cut off tumors' blood supply. Currently, the focus is on chimerizing several hybridomas that produce anti-KDR monoclonal antibodies. A Phase I safety study is expected to finish by the end of the year.
Rabney said ImClone ranks the BEC2 program last in importance, even though it's in Phase III studies. "We place more value on the other two programs," she said.
Other projects "will be moving into the clinic over the next one-year or two-year time period," she added.