Thema: Presse: NeoPharm enrolls first patient in IL13-PE38QQR P-Trial
Presse: NeoPharm enrolls first patient in IL13-PE38QQR P-Trial
Doreen[a]
10.03.2004 18:51:50
Enrolls First Patient In IL13-PE38QQR "Precise´´ Trial
NeoPharm, Inc. 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 (GBM), a deadly form of brain cancer with few current treatment options. IL13-PE38QQR has received orphan drug designation in Europe and the U.S., and fast track drug development program status from the U.S. Food and Drug Administration (FDA). 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. A number of the world´s leading brain tumor treatment centers and investigators have agreed to participate in the PRECISE trial to further the study of treatments for malignant glioma. These centers include:
University of Alabama at Birmingham; University of California-San Francisco; University of Southern California/Norris Cancer Center, Los Angeles, California; University of Colorado Health Sciences Center, Denver, Colorado; Yale University School of Medicine, New Haven, Connecticut; Northwestern University-Brain Tumor Center, Chicago, Illinois; Evanston Northwestern Healthcare, Evanston, Illinois; Henry Ford Health Systems, Detroit, Michigan; Memorial Sloan Kettering Cancer Center, New York, New York; Carolina Neurosurgery and Spine Associates, Charlotte, North Carolina; Duke University Medical Center, Durham, North Carolina; Wake Forest University, Winston Salem, North Carolina; Cleveland Clinic Foundation, Cleveland, Ohio; The University of Pennsylvania, Philadelphia, Pennsylvania; University of Texas - M.D. Anderson Cancer Center; University of Virginia Health Systems, Charlottesville, Virginia; Toronto Western Hospital, 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 Evaluation of Convection Enhanced Delivery of IL13-PE38QQR with Survival Endpoint, is a randomized, controlled Phase III clinical trial. It is designed to compare overall survival, drug safety and quality of life of patients receiving IL13-PE38QQR with patients receiving GLIADEL® 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) using catheters placed following the resection, and 100 patients receive GLIADEL® Wafer placed at the time of resection. Enrollment in PRECISE is expected to be completed in 2005.
About Malignant Glioma
Malignant gliomas, which includes glioblastoma multiforme (GBM), anaplastic astrocytoma 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 exotoxin, 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 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.
NeoPharm, Inc. 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 (GBM), a deadly form of brain cancer with few current treatment options. IL13-PE38QQR has received orphan drug designation in Europe and the U.S., and fast track drug development program status from the U.S. Food and Drug Administration (FDA). 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. A number of the world´s leading brain tumor treatment centers and investigators have agreed to participate in the PRECISE trial to further the study of treatments for malignant glioma. These centers include:
University of Alabama at Birmingham; University of California-San Francisco; University of Southern California/Norris Cancer Center, Los Angeles, California; University of Colorado Health Sciences Center, Denver, Colorado; Yale University School of Medicine, New Haven, Connecticut; Northwestern University-Brain Tumor Center, Chicago, Illinois; Evanston Northwestern Healthcare, Evanston, Illinois; Henry Ford Health Systems, Detroit, Michigan; Memorial Sloan Kettering Cancer Center, New York, New York; Carolina Neurosurgery and Spine Associates, Charlotte, North Carolina; Duke University Medical Center, Durham, North Carolina; Wake Forest University, Winston Salem, North Carolina; Cleveland Clinic Foundation, Cleveland, Ohio; The University of Pennsylvania, Philadelphia, Pennsylvania; University of Texas - M.D. Anderson Cancer Center; University of Virginia Health Systems, Charlottesville, Virginia; Toronto Western Hospital, 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 Evaluation of Convection Enhanced Delivery of IL13-PE38QQR with Survival Endpoint, is a randomized, controlled Phase III clinical trial. It is designed to compare overall survival, drug safety and quality of life of patients receiving IL13-PE38QQR with patients receiving GLIADEL® 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) using catheters placed following the resection, and 100 patients receive GLIADEL® Wafer placed at the time of resection. Enrollment in PRECISE is expected to be completed in 2005.
About Malignant Glioma
Malignant gliomas, which includes glioblastoma multiforme (GBM), anaplastic astrocytoma 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 exotoxin, 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 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.
Doreen[a]
