Washington Editor

ImClone Systems Inc. is looking to expand an ongoing Phase II trial of the investigational colorectal cancer drug Erbitux by offering the product to the sickest patients through a limited access program administered by the National Organization for Rare Disorders (NORD).

ImClone and partner Bristol-Myers Squibb Co. (BMS) late Thursday released a joint statement saying Erbitux (cetuximab) will be made available to patients with epidermal growth factor receptor (EGFR)-positive metastatic colorectal cancer who are not eligible for current studies and who have exhausted other treatment options.

Data collected from this additional class of patients will supplement a 250-patient Phase II trial of Erbitux monotherapy in patients with colorectal cancer who are refractory or intolerant to chemotherapy, Tracy Furey, BMS spokeswoman, told BioWorld Today.

ImClone and BMS, both of New York, initiated the Phase II trial last August following a scandal surrounding business practices related to previous studies of Erbitux and the rolling biologics license application rejected by the FDA in December 2001. (See BioWorld Today, Jan. 3, 2002, and Oct. 8, 2002.)

ImClone's co-founder and former CEO, Samuel Waksal, brother of the current CEO, Harlan Waksal, pleaded guilty last year to bank fraud, securities fraud and other related felonies after being accused of tipping off family and friends ahead of releasing the FDA's rejection to the public. Samuel Waksal's spokesman on Friday told BioWorld Today that the immunologist and former CEO is expected to be sentenced by a federal judge in New York on March 17. The January sentencing date was postponed due to an incomplete pre-sentencing report. (See BioWorld Today, Oct. 16, 2002.)

While Samuel Waksal has been in and out court, ImClone and BMS have spent the last year trying to pick up the pieces from a failed attempt to win FDA approval of their monoclonal antibody.

David Pitts, a spokesman for ImClone, said the companies continue enrolling the Phase II trial and data are expected late this year. However, neither Pitts nor Furey was sure when the BLA would be refiled, or whether the companies would seek accelerated approval.

Furthermore, to make a better case for Erbitux, the companies in October submitted two protocols for randomized Phase III trials. Furey said the trials, designed for second-line metastatic colorectal cancer, are under discussion at the FDA.

In other Erbitux news, Merck KGaA, of Darmstadt, Germany, is expected to release results from its European pivotal trial of Erbitux in 330 irinotecan-refractory colorectal cancer patients in May at the American Society of Clinical Oncology meeting. The design of the Merck trial has been criticized because patients in the control arm received Erbitux. (See BioWorld Today, Nov. 4, 2002.)

ImClone's stock (NASDAQ:IMCL) closed Friday at $9.39, up 38 cents.