ImClone Systems has initiated an additional phase Ib/IIa clinical
trial of C225, the company's epidermal growth factor (EGF)-receptor
antagonist. The dose-escalation study will evaluate C225 in conjunction
with the chemotherapeutic agent paclitaxel (Taxol) in patients
suffering from EGF receptor-positive breast carcinoma. C225 is
designed to block the EGF receptor, which is overexpressed in
several varieties of cancer. In combination with chemotherapy
or radiation, C225 eliminates cancerous cells through a mechanism
that is believed to involve the induction of apoptosis, the natural
process of cell death.
The multisite trial will be conducted at Memorial Hospital, the
patient care arm of Memorial Sloan-Kettering Cancer Center, under
the direction of Larry Norton, MD, and at the Yale University
School of Medicine, Department of Medicine under the direction
of Barbara Burtness, MD. Patients will receive C225 by weekly
intravenous administration in a multiple-injection dose-escalation
study in combination with paclitaxel.
ImClone recently announced the initiation of a phase Ib/IIa clinical
trial to evaluate C225 in conjunction with doxorubicin in patients
suffering from advanced prostate carcinoma. In addition, multiple
phase Ib/IIa studies of C225 are currently being conducted in
patients with advanced head and neck and lung carcinomas. Patients
in these studies are being treated with C225 in combination with
"The breast cancer study marks the third of our phase Ib/IIa
clinical trials of C225 targeting specific tumors in combination
with chemotherapeutic agents," said Harlan W. Waksal, MD,
Executive Vice President and Chief Operating Officer of ImClone
Systems, "The results of these studies will provide valuable
safety and pharmacokinetic data regarding C225. Moreover, they
will further demonstrate the potential marketing breadth of this
product in various cancer indications."
Pronounced Activity Against Breast Cancer Cell Lines
Animal studies evaluating the use of C225 activity against human
breast cancer cell lines showed pronounced antitumor activity
resulting in the complete destruction of the human tumor cells
in the experimental model. These experiments also demonstrated
long-term tumor-free survival of the animals.
The EGF receptor is expressed in select normal human tissue and
has been shown to be overexpressed in the cells of approximately
one-third of all cancers. Antibodies directed against the EGF
receptor may inhibit the uncontrolled cancer cell growth that
has been shown to be associated with this receptor's activity.
Potential indications for C225 include head and neck, lung, breast,
prostate, and ovarian cancers.