NeoPharm Enrolls First Patient In IL13-PE38QQR ``Precise'' Trial; www.PRECISETrial.com Available for More Study Information.Business Editors/Health/Medical Writers BIOWIRE2K LAKE FOREST, Ill.--(BUSINESS WIRE)--March 8, 2004 NeoPharm, Inc. (Nasdaq/NM: NEOL) announced today that it has begun enrolling patients in PRECISE, the Company's pivotal Phase III trial of its experimental tumor-targeting, anti-cancer drug IL13-PE38QQR in the treatment of recurrent glioblastoma multiforme glioblastoma mul·ti·for·me n. A virulent brain cancer that is usually fatal. (GBM GBM 1 Glioblastoma multiforme, see there 2. Glomerular basement membrane ), a deadly form of brain cancer with few current treatment options. IL13-PE38QQR has received orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the designation in Europe and the U.S., and fast track drug development program status from the U.S. Food and Drug Administration (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. ). NeoPharm's IL13-PE38QQR development program was also recently selected to participate in the new U.S. Food and Drug Administration (FDA) Continuous Marketing Application Pilot 2 Program (http://www.fda.gov/cber/gdlns/pdufa2.htm). A number of the world's leading brain tumor Brain Tumor Definition A brain tumor is an abnormal growth of tissue in the brain. Unlike other tumors, brain tumors spread by local extension and rarely metastasize (spread) outside the brain. treatment centers and investigators have agreed to participate in the PRECISE trial to further the study of treatments for malignant glioma glioma /gli·o·ma/ (gli-o´mah) a tumor composed of neuroglia in any of its states of development; sometimes extended to include all intrinsic neoplasms of the brain and spinal cord, as astrocytomas, ependymomas, etc. . These centers include: -- University of Alabama at Birmingham UAB began in 1936 as the Birmingham Extension Center of the University of Alabama. Because of the rapid growth of the Birmingham area, it was decided that an extension program for students who had difficulties which prevented them from studying in Tuscaloosa was needed. ; -- University of California-San Francisco; -- University of Southern California/Norris Cancer Center, Los Angeles, California; -- University of Colorado Health Sciences Center The University of Colorado Health Sciences Center (UCHSC) is part of the University of Colorado System. It has recently been merged with the University of Colorado at Denver (UCD) to form the University of Colorado at Denver and Health Sciences Center. , Denver, Colorado; -- Yale University School of Medicine, New Haven, Connecticut; -- Northwestern University-Brain Tumor Center, Chicago, Illinois; -- Evanston Northwestern Healthcare Evanston Northwestern Healthcare, located in Chicago's northern suburbs, is an academic health system affiliated with the McGaw Medical Center of Northwestern University and all attending physicians are on faculty at the Feinberg School of Medicine. , Evanston, Illinois; -- Henry Ford Health Systems, Detroit, Michigan; -- Memorial Sloan Kettering Cancer Center, New York, New York; -- Carolina Neurosurgery neurosurgery /neu·ro·sur·gery/ (noor´o-sur?jer-e) surgery of the nervous system. neu·ro·sur·ger·y n. Surgery on any part of the nervous system. and Spine Associates, Charlotte, North Carolina; -- Duke University Medical Center, Durham, North Carolina Durham is a city in the U.S. state of North Carolina. It is the county seat of Durham CountyGR6 and is the fourth-largest city in the state by population. ; -- Wake Forest University, Winston Salem, North Carolina This article is about Salem in Burke County, North Carolina. For the Salem in Forsyth County, North Carolina, see Winston-Salem, North Carolina or Old Salem. Salem is a census-designated place (CDP) in Burke County, North Carolina, United States. ; -- Cleveland Clinic Foundation, Cleveland, Ohio; -- The University of Pennsylvania (body, education) University of Pennsylvania - The home of ENIAC and Machiavelli. http://upenn.edu/. Address: Philadelphia, PA, USA. , Philadelphia, Pennsylvania; -- University of Texas - M.D. Anderson Cancer Center; -- University of Virginia Health Systems, Charlottesville, Virginia; -- Toronto Western Hospital The Toronto Western Hospital is located at the corner of Bathurst Street and Dundas Street West in Toronto, Canada. It is part of the University Health Network. TWH has 256 beds, with 46,000 visits to its emergency department annually. , Toronto, Canada; -- University Hospital Eppendorf, Hamburg, Germany; -- Sourasky Medical Center, Tel Aviv, Israel; -- Academisch Ziekenhuis Groningen Afd Neurochirurgie, Groningen, Netherlands; -- The Walton Center for Neurology & Neurosurgery, Liverpool, United Kingdom. The Company also plans to add additional centers as the PRECISE Trial progresses. "We are pleased that these prestigious neuro-oncology and neuro-surgery centers have agreed to participate in the PRECISE Trial," said James M. Hussey, NeoPharm's Chief Executive Officer. "A number of these centers participated in our Phase I/II clinical trials of IL13-PE38QQR, the results of which were integral to developing the pivotal Phase III PRECISE trial." According to Sandeep Kunwar, MD, Assistant Professor of Neurological Surgery and Principal Investigator, Brain Tumor Research Center, at the University of California-San Francisco, "The selective molecular targeting of IL13-PE38QQR, when coupled with positive-pressure Convection Enhanced Delivery, is among the most promising therapies we have observed in controlling aggressive and recurrent brain tumors. We are excited to embark on this Phase III Trial to hopefully validate the potential of this new approach to prolonging survival and improving quality of life in this group of patients." Dr. Kunwar has extensive experience as an investigator in the Company's Phase I/II clinical trials of IL13-PE38QQR, and will also be an investigator for the PRECISE Trial. About PRECISE PRECISE, which stands for Phase III Randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. Evaluation of Convection Enhanced Delivery of IL13-PE38QQR with Survival Endpoint, is a randomized, controlled Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the . It is designed to compare overall survival, drug safety and quality of life of patients receiving IL13-PE38QQR with patients receiving GLIADEL(R) Wafer in the treatment of first recurrent GBM following surgical tumor resection (removal). As one of the largest international Phase III trials of its kind, PRECISE will seek to enroll 300 patients in multiple centers across North America, Europe and Israel. Patients will be randomized so that 200 patients receive IL13-PE38QQR via Convection Enhanced Delivery (CED (Capacitance Electronic Disc) An earlier videodisc technology from RCA that was released in 1981 and abandoned five years later. Like phonograph records, the analog disc contained grooves that a stylus rode over. ) using catheters placed following the resection, and 100 patients receive GLIADEL(R) Wafer placed at the time of resection. Enrollment in PRECISE is expected to be completed in 2005. For additional details regarding the PRECISE trial design, enrollment criteria, and participating centers please visit www.clinicaltrials.gov (keyword: IL13-PE38QQR) or www.precisetrial.com. About Malignant Glioma Malignant gliomas, which includes glioblastoma multiforme (GBM), anaplastic an·a·plas·tic adj. 1. Relating to the surgical restoration of a lost or absent part. 2. Of, relating to, or characterized by cells that have become less differentiated. anaplastic 1. astrocytoma astrocytoma /as·tro·cy·to·ma/ (as?tro-si-to´mah) a tumor composed of astrocytes; the most common type of primary brain tumor and also found throughout the central nervous system, classified on the basis of histology or in order of and malignant mixed oligoastrocytoma tumors, are the most common and aggressive form of primary brain tumors. GBM is a highly malignant, rapidly infiltrating, primary brain tumor that penetrates surrounding brain tissue and is the most common and aggressive form of malignant glioma. GBM, like most malignant gliomas, is known to recur in a location close to the resection cavity left by the removal of the tumor. As there are currently limited treatment options to prevent rapid recurrence of the tumor once the tumor is surgically resected, most people usually survive for less than one year after initial diagnosis. About IL13-PE38QQR The key to making a useful tumor-targeting drug is the use of a targeting mechanism that is able to select and destroy tumor cells while bypassing healthy normal cells. IL13-PE38QQR is a recombinant protein consisting of a single molecule composed of two parts: a tumor-targeting molecule (IL13) and a cytotoxic agent (Pseudomonas Pseudomonas A genus of gram-negative, nonsporeforming, rod-shaped bacteria. Motile species possess polar flagella. They are strictly aerobic, but some members do respire anaerobically in the presence of nitrate. exotoxin exotoxin /exo·tox·in/ (ek´so-tok?sin) a potent toxin formed and excreted by the bacterial cell, and free in the surrounding medium. , or PE). In studies conducted by NeoPharm, the cancer cell appears to bind onto and absorb the IL13, as well as the attached PE, which results in the death of the cancer cell. Healthy brain cells do not appear to express IL13 receptors, and thus, do not appear to internalize internalize To send a customer order from a brokerage firm to the firm's own specialist or market maker. Internalizing an order allows a broker to share in the profit (spread between the bid and ask) of executing the order. the PE. About Convection Enhanced Delivery Convection enhanced delivery (CED) involves the placement of one or more catheters into a brain tumor or nearby brain tissue to deliver a slow, continuous infusion of a drug or other substance over several days, directed against the tumor. This technique allows relatively large volumes of brain tissue to be treated. CED is designed to infuse IL13-PE38QQR directly to the tumor resection site and adjacent brain tissue to prevent recurrence of tumor cell growth. About GLIADEL(R) Wafers A GLIADEL(R) Wafer delivers BCNU BCNU - Be seein' you. (or carmustine), a commonly used chemotherapeutic anti-tumor agent for GBM, directly to the brain tumor resection cavity. Up to eight dime-sized wafers are placed in the space once occupied by the tumor at the time of resection. The wafers slowly dissolve over the next two to three weeks, bathing the surrounding cells with BCNU. GLIADEL(R) Wafer has been approved by the FDA for the treatment of recurrent and newly diagnosed GBM. About NeoPharm NeoPharm, Inc., based in Lake Forest, IL, is a publicly traded biopharmaceutical company dedicated to the research, development and commercialization of new and innovative cancer drugs for therapeutic applications. The Company has a portfolio of compounds in various stages of development. Additional information about NeoPharm, recent news releases, and scientific abstracts related to IL13-PE38QQR can be obtained by visiting NeoPharm's Website at: www.neophrm.com , or calling Paul Arndt at 847-295-8678. Forward Looking Statements - This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The Company has tried to identify such forward-looking statements by use of such words as "expects," "intends," "hopes," "anticipates," "believes," "could," "may," "evidences" and "estimates," and other similar expressions, but these words are not the exclusive means of identifying such statements. Such statements include, but are not limited to, any statements relating to the Company's drug development program, including, but not limited to the initiation, progress and outcomes of clinical trials involving IL13-PE38QQR, including the PRECISE trial, and any other statements that are not historical facts. Such statements involve risks and uncertainties, including, but not limited to, those risks and uncertainties relating to difficulties or delays in development, testing, regulatory approval, production and marketing of the Company's drug and non-drug compounds, including, but not limited to, IL13-PE38QQR, uncertainty regarding the outcome of damage claims made by or against the Company, including the outcome of the pending arbitration with Pharmacia, unexpected adverse side effects or inadequate therapeutic efficacy of the Company's drug and non-drug compounds that could slow or prevent products coming to market, uncertainty regarding the Company's ability to market its drug and non-drug products directly or through independent distributors, the uncertainty of patent protection for the Company's intellectual property or trade secrets, including, but not limited to, IL13-PE38QQR, and other risks detailed from time to time in filings the Company makes with the Securities and Exchange Commission including our annual reports on Form 10-K and our quarterly reports on Forms 10-Q. Such statements are based on management's current expectations, but actual results may differ materially due to various factors, including those risks and uncertainties mentioned or referred to in this press release. Accordingly, you should not rely on these forward-looking statements as a prediction of actual future results. |
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