http://www.medicalnewstoday.com/articles/118498.php
ImClone Systems Incorporated (NASDAQ: IMCL), a global leader in the development and commercialization of novel antibodies to treat cancer, today announced that the first patient has been treated in a global Phase 3 clinical trial of IMC-1121B, its anti-vascular endothelial growth factor receptor-2 (VEGFR-2) IgG1 monoclonal antibody, in women with metastatic breast cancer.
"Since the growth of breast cancer is dependent on VEGFR-2 activation, IMC-1121B presents a unique opportunity to optimize this therapeutic approach as IMC-1121B uniquely binds to the VEGFR-2 receptor itself, thereby blocking many VEGF ligands from activating it," said Eric K. Rowinsky, M.D., Executive Vice President and Chief Medical Officer of ImClone. "Unlike bevacizumab that targets only a single ligand, and unlike small molecule drugs that target many unrelated receptors, IMC-1121B specifically targets only VEGFR-2. This clinical trial will help us understand whether this approach produces greater activity with fewer side effects."
In April 2008, ImClone announced the establishment of an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for this trial. The SPA is a written agreement between the trial's sponsor and the FDA regarding the design and size of the Phase 3 trial to be used in generating the primary clinical data necessary to support approval of an efficacy claim in conjunction with the submission of a new drug application (NDA) or biologics licensing application (BLA).
Pursuant to the SPA, this Phase 3 trial is a randomized, double-blind, placebo-controlled trial of IMC-1121B plus docetaxel in women with unresectable locally-recurrent or metastatic breast cancer who have not received prior chemotherapy in the locally-recurrent or metastatic setting. The trial, which is being conducted under the auspices of the Cancer International Research Group, doing business as Translational Research in Oncology (TRIO), is expected to enroll approximately 1,100 patients who will be randomized (2:1) to receive either IMC-1121B plus docetaxel or placebo plus docetaxel. The primary endpoint of the trial is progression-free survival. The trial will be conducted at more than 200 sites throughout the world.
"This trial of IMC-1121B highlights the efforts of TRIO to bring promising new therapies to women with breast cancer, which remains the most frequently diagnosed cancer among women today," said John Mackey, M.D., FRCPC, Professor of Oncology at the University of Alberta, and Principal Investigator of the study. "Our efforts also demonstrate TRIO's commitment to transforming our understanding of cancer biology into clinical trials by testing compounds, like IMC-1121B, across the spectrum of human cancer."
IMC-1121B is a fully human IgG1 monoclonal antibody designed to bind to the extracellular domain of VEGFR-2 found on tumor vasculature, thereby inhibiting certain ligands known as vascular endothelial growth factors from binding to and activating the receptor. This action blocks a signaling pathway key to new blood vessel formation in growing tumors, which has been shown to starve tumors of their nutrient supply and result in significant tumor growth inhibition in pre-clinical models. In 2007, ImClone completed enrollment into two Phase 1 studies of IMC-1121B, which demonstrated favorable safety and pharmacokinetic profiles, as well as objective antitumor activity as a single agent in several patients with refractory solid cancers when administered either weekly or every two or three weeks. In addition to this Phase 3 study of IMC-1121B in women with breast cancer, disease-directed studies of IMC-1121B in patients with advanced melanoma, renal and liver cancers have begun to enroll patients, and additional Phase 2 and 3 evaluations are in various stages of development.
Linear Mode
