EOPHARM BEGINS NEW GLOBAL TRIAL OF IL13-PE38 FOR MALIGNANT GLIOMA.NeoPharm, Inc. (Nasdaq National Market: NEOL), Lake Forest, Ill., has announced further progress in its clinical development program for IL13-PE38, NeoPharm's novel tumor-targeted agent. Enrollment has begun in the first global Phase I/II clinical trial of IL13-PE38; the third clinical study to date in patients with recurrent or progressive malignant glioma. The trial is being conducted at six participating sites including University Hospital Eppendorf and University Hospital Kiel in Germany, Chaim Sheba Medical Center and Dana Hospital Tel Aviv in Israel, Cleveland Clinic and University of Colorado University of Colorado may refer to:
James M. Hussey, NeoPharm's president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. commented: "The vast unmet global need for an effective treatment for malignant glioma has influenced our clinical development strategy. Premier research sites outside the United States have joined our cadre of U.S. centers to help expedite the world-wide development of IL13-PE38." NeoPharm has exclusively licensed IL13-PE38 from the National Cancer Institute and the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. , and is developing the agent under a Cooperative Research and Development Agreement “CRADA” redirects here. For other uses, see CRADA (disambiguation). A Cooperative Research and Development Agreement (CRADA) is an agreement between a government agency and a private company to work together. (CRADA CRADA Cooperative Research And Development Agreement ) with the FDA's Center for Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the Food and Drug Administration, which is in the United States Department of Health and Human Services. (CBER). The compound received orphan drug designation from the FDA in November 2001 and EC in May 2002. Additionally, the IL13-PE38 development program has received fast track designation by the FDA. About NeoPharm NeoPharm, Inc., based in Lake Forest, IL, is a publicly traded biopharmaceutical company dedicated to the research, discovery and commercialization of new and innovative cancer drugs for therapeutic applications. The company has a broad portfolio of compounds in various stages of development. Background Information The Mechanism of IL13-PE38 Malignant glioma cells, as compared to normal brain cells, express interleukin-13 (IL13) receptors at a high density. IL13 is an immune regulatory cytokine, or protein, secreted by cells. IL13-PE38 (a recombinant protein) is designed to detect and bind to IL13 receptors on the surface of malignant glioma cancer cells. It then selectively delivers a potent bacterial cytotoxic agent called PE38 derived from Pseudomonas bacterium to destroy tumor cells while sparing healthy surrounding cells. IL13-PE38 is administered directly to the tumor through positive-pressure Convection Enhanced Delivery (CED), which uses catheters inserted in the brain before and/or following surgical resection (removal) of the tumor to prevent recurrence of cancer cell growth. Phase I/II IL13-PE38 Clinical Program IL13-PE38 is currently in two other Phase I/II clinical trials for malignant glioma. The first IL13-PE38 clinical study is being conducted through the NCI See Liberate. Clinical Trial Evaluation Program (CTEP)-funded New Approaches to Brain Tumor Therapy (NABTT NABTT New Approaches to Brain Tumor Therapy ) Consortium. Johns Hopkins University Johns Hopkins University, mainly at Baltimore, Md. Johns Hopkins in 1867 had a group of his associates incorporated as the trustees of a university and a hospital, endowing each with $3.5 million. Daniel C. Medical Center is the coordinating site for NABTT. The first human clinical data on IL13-PE38 from this study was presented last Fall at the Sixth Annual Meeting of the World Federation of Neuro-Oncology/Society for Neuro-Oncology (SNO). These data indicated that IL13-PE38 may have potential as a safe and effective treatment for malignant glioma. A second clinical study, which is being conducted through NeoPharm, and includes M.D. Andersen Cancer Center (MDACC), Memorial Sloan Kettering Cancer Center (MSKCC), the University of California The University of California has a combined student body of more than 191,000 students, over 1,340,000 living alumni, and a combined systemwide and campus endowment of just over $7.3 billion (8th largest in the United States). San Francisco (UCSF) and Yale University as participating centers, was initially presented at the World Federation of Neuro-Oncology Society/SNO meeting. Additional data was announced on April 11-12, 2002 at the CNS See Continuous net settlement. CNS See continuous net settlement (CNS). Section on Tumors Fifth Biennial Satellite Symposium, held in conjunction with the American Association of Neurological Surgeons (AANS) Annual Meeting in Chicago. The clinical data presented to date has been promising. For more information, visit http://www.neophrm.com or call 847/295-8678. |
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