�ImClone Systems Incorporated (NASDAQ: IMCL), a global loss leader in the development and commercialization of novel antibodies to treat cancer, today announced that the first patient has been hardened 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 white meat cancer.
"Since the growth of breast cancer is dependent on VEGFR-2 activation, IMC-1121B presents a unique opportunity to optimize this therapeutic approaching as IMC-1121B uniquely binds to the VEGFR-2 sensory receptor itself, thereby blocking many VEGF ligands from activating it," aforementioned Eric K. Rowinsky, M.D., Executive Vice President and Chief Medical Officer of ImClone. "Unlike bevacizumab that targets only when 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 access produces greater activity with fewer position effects."
In April 2008, ImClone proclaimed the establishment of an agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for this test. 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 secondhand in generating the primary clinical data necessary to support approval of an efficacy claim in conjunction with the submission of a new drug lotion (NDA) or biologics licensing application (BLA).
Pursuant to the SPA, this Phase 3 trial is a randomized, double blind, placebo-controlled test of IMC-1121B plus docetaxel in women with unresectable locally-recurrent or metastatic titty cancer world Health Organization have non 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 occupation as Translational Research in Oncology (TRIO), is expected to recruit approximately 1,100 patients who testament be randomised (2:1) to receive either IMC-1121B plus docetaxel or placebo plus docetaxel. The elemental endpoint of the trial is progression-free survival. The trial testament be conducted at more than 200 sites throughout the public.
"This visitation of IMC-1121B highlights the efforts of TRIO to bring bright new therapies to women with bosom cancer, which remains the most oftentimes diagnosed cancer 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 demonstrate TRIO's commitment to transforming our agreement of crab biology into clinical trials by testing compounds, like IMC-1121B, crossways the spectrum of human cancer."
IMC-1121B is a fully human IgG1 monoclonal antibody intentional to tie to the extracellular domain of VEGFR-2 found on tumor vasculature, thereby inhibiting certain ligands known as vascular endothelial growth factors from bandaging 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 starve tumors of their nutrient supply and result in significant tumour growth inhibition in presymptomatic models. In 2007, ImClone completed enrollment into deuce Phase 1 studies of IMC-1121B, which demonstrated favorable safety and pharmacokinetic profiles, as well as nonsubjective antitumor activity as a single agent in several patients with refractory solid cancers when administered either weekly or every 2 or trey weeks. In addition to this Phase 3 survey 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 enter patients, and additional Phase 2 and 3 evaluations are in various stages of development.
About TRIO
TRIO, which was created as an international research network in oncology in 1997, is an academic global network of investigators capable of rapid accrual to clinical trials. TRIO arose kayoed of the need to address the increasing figure 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 new cancer agents in tit cancer and many other disease settings. TRIO has been highly successful in maintaining a strong and enthusiastic network by offer innovative and exciting science, and more than recently, translational research. TRIO consists of an operations infrastructure that uses comprehensive pharmaceutical industry standards. By combining these two strategies, that of increasing patient access through global police detective sites and that of applying efficient, well-established clinical trial operation systems, TRIO has since become recognised for its high quality data and rapid accumulation rates. TRIO has besides been highly successful at captivating the interests of patients and investigators throughout the world, in part, due to the internalization of high quality and exciting science 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-moving oncology attention by development and commercializing a portfolio of targeted biologic treatments designed to address the medical of necessity of patients with a variety of cancers. The Company's research and evolution programs include growth factor blockers and angiogenesis inhibitors. ImClone Systems' headquarters and research trading operations are located in New York City, with additional administration and manufacturing facilities in Branchburg, New Jersey. For more than information around ImClone Systems, please visit the Company's web site at hypertext transfer protocol://www.imclone.com.
Certain matters discussed in this news release may found 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 bathroom give no assurance that its expectations will be achieved. Forward-looking information is subject to certain risks, trends and uncertainties that could movement actual results to differ materially from those currently expected. Many of these factors are beyond the company's ability to control or auspicate. Important factors that may cause literal results to differ materially and could impact the company and the statements contained in this news release tin be launch in the company's filings with the Securities and Exchange Commission, particularly those factors identified as "peril factors" in the Company's most late annual report 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 release, the company 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 solvent of new information, future events or otherwise.
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