�ImClone Systems Incorporated (NASDAQ: IMCL), a global leader in the development and commercialization of novel antibodies to treat cancer, today announced that the starting time 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 antibody, in women with metastatic chest cancer.
"Since the growth of breast cancer is dependent on VEGFR-2 activation, IMC-1121B presents a singular opportunity to optimize this therapeutic approach as IMC-1121B uniquely binds to the VEGFR-2 receptor itself, thereby blocking many VEGF ligands from energizing it," aforesaid 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 validation 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 shop and the FDA regarding the conception and size of the Phase 3 trial to be used in generating the basal clinical data necessary to support approval of an efficacy claim in conjunction with the submission of a newfangled drug application (NDA) or biologics licensing application (BLA).
Pursuant to the SPA, this Phase 3 trial is a randomized, double blind, placebo-controlled tribulation of IMC-1121B plus docetaxel in women with unresectable locally-recurrent or metastatic breast cancer world Health Organization have non received prior chemotherapy in the locally-recurrent or metastatic setting. The trial, which is beingness conducted under the auspices of the Cancer International Research Group, doing business as Translational Research in Oncology (TRIO), is expected to enter 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 volition be conducted at more than two hundred sites passim the world.
"This trial of IMC-1121B highlights the efforts of TRIO to bring promising new therapies to women with white meat cancer, which remains the most oftentimes diagnosed crab among women today," aforementioned John Mackey, M.D., FRCPC, Professor of Oncology at the University of Alberta, and Principal Investigator of the study. "Our efforts also certify TRIO's commitment to transforming our understanding of genus 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 intentional to bandage to the extracellular domain of a function of VEGFR-2 found on tumor vasculature, thereby inhibiting certain ligands known as vascular endothelial growth factors from cover to and activating the receptor. This action blocks a sign pathway key to new blood vessel formation in growing tumors, which has been shown to crave tumors of their nutrient supply and result in significant neoplasm growth suppression in preclinical models. In 2007, ImClone completed registration into two Phase 1 studies of IMC-1121B, which demonstrated favorable safety and pharmacokinetic profiles, as advantageously as documentary antitumor activity as a single agent in several patients with refractory solid cancers when administered either weekly or every deuce or terzetto 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 recruit patients, and additional Phase 2 and 3 evaluations are in various stages of developing.
About TRIO
TRIO, which was created as an international inquiry network in oncology in 1997, is an donnish global network of investigators capable of rapid accumulation to clinical trials. TRIO arose verboten of the need to address the increasing number of new anticancer drugs and targeted therapies in development. TRIO has selected dedicated investigators from all around the world to participate in pivotal trials of fresh cancer agents in breast cancer and many other disease settings. TRIO has been highly successful in maintaining a strong and enthusiastic network by offering innovative and exciting science, and more than recently, translational research. TRIO consists of an operations infrastructure that uses comprehensive pharmaceutical diligence standards. By combining these two strategies, that of increasing patient access through global investigator sites and that of applying effective, well-established clinical trial military operation systems, TRIO has since become accepted for its high quality data and rapid accrual rates. TRIO has also been highly successful at captivating the interests of patients and investigators throughout the public, in contribution, due to the incorporation of high school quality and exciting skill into its clinical evaluations. TRIO was incorporated as a Canadian not for profit entity in 1999.
About ImClone Systems
ImClone Systems Incorporated is a fully integrated global biopharmaceutical company committed to forward oncology care by developing and commercializing a portfolio of targeted biologic treatments designed to address the medical inevitably of patients with a variety of cancers. The Company's research and development programs include growth agent blockers and angiogenesis inhibitors. ImClone Systems' headquarters and research operations are placed in New York City, with extra administration and manufacturing facilities in Branchburg, New Jersey. For more than information nigh ImClone Systems, please visit the Company's web site at hypertext transfer protocol://www.imclone.com.
Certain matters discussed in this news sacking may name forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Federal securities laws. Although the company believes that the expectations reflected in such advanced statements are based upon reasonable assumptions it buttocks give no assurance that its expectations will be achieved. Forward-looking information is subject to certain risks, trends and uncertainties that could cause actual results to dissent materially from those presently expected. Many of these factors ar beyond the company's ability to control or foretell. Important factors that may cause actual results to differ materially and could impact the company and the statements contained in this word release crapper be constitute in the company's filings with the Securities and Exchange Commission, particularly those factors identified as "hazard factors" in the Company's most recent annual write up of Form 10-K and in its quarterly reports on Form 10-Q and current reports on Form 8-K. For forward-looking statements in this news sack, the fellowship claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The company assumes no obligation to update or supplement whatever forward-looking statements whether as a upshot of unexampled information, future events or otherwise.
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