Thema: Presse: New approaches to brain tumor therapy
Presse: New approaches to brain tumor therapy
Mario[a]
02.11.2005 15:23:27
Peregrine Pharmaceuticals and New Approaches to Brain Tumor Therapy (NABTT) Consortium Initiate Cotara(R) Brain Cancer Trial
Monday August 29, 2005
Peregrine Pharmaceuticals, Inc. and the New Approaches to Brain Tumor Therapy (NABTT) Consortium today announced the initiation of a clinical trial designed to confirm the dosing, safety and efficacy of a single intratumoral infusion of Cotara® in the treatment of glioblastoma multiforme (GBM), a common and deadly form of brain cancer.
The National Cancer Institute-approved protocol titled, "An Open-Label, Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B (Cotara®) for the Treatment of Glioblastoma Multiforme at 1st or 2nd Relapse," will evaluate safety, radiation exposure and efficacy of a single dose of Cotara®. The study represents the first part of Peregrine´s FDA-approved product registration clinical trial for Cotara®.
The trial will enroll patients at four NABTT institutions; Wake Forest University, Emory University, University of Alabama at Birmingham and University of Pennsylvania. Up to 28 patients will be enrolled in this trial.
"Glioblastoma multiforme is an aggressive and fatal cancer with few treatment options, and we are anxious to evaluate this novel study drug in patients," said Dr. Kevin Judy of the University of Pennsylvania, the Neurosurgery Chair for the study.
About Glioblastoma Multiforme
Glioblastoma multiforme (GBM) is the most common and clinically aggressive brain cancer and is associated with a grave prognosis. Approximately 80% of patients relapse within 6-12 months after treatment, with an overall median survival time for patients with newly diagnosed GBM of approximately 12 months.
In 2004, the American Cancer Society estimated that 18,400 new cases and 12,690 deaths were attributed to primary malignant brain (e.g. GBM) and central nervous system cancers in the U.S. Current therapeutic modalities include surgery, radiotherapy, and chemotherapy. However, most glioblastomas cannot be completely resected or irradiated due to the infiltrating fingers of tumor that characterize their growth. Additionally, the "blood-brain barrier" prevents most chemotherapeutic agents from reaching the tumor at therapeutic concentrations.
About Cotara® in the Treatment of Brain Cancer
Cotara® is the registered trademark for a chimeric tumor-necrosis therapy (TNT) antibody attached to Iodine-131, a radioactive agent. Cotara® is designed to bind to the dead or dying tissue present in virtually all solid tumors. Using this necrotic core as a stable anchorage, Cotara® delivers a cytotoxic radioisotope to the heart of the tumor, irradiating and killing nearby, living tumor cells.
In a prior phase 2 study, a subset analysis of recurrent GBM patients who received a therapeutic dose of Cotara® between 1.25 and 2.5 mCi/cc of tumor volume demonstrated a 58% improvement in median survival (38 versus 24 weeks) compared to patients treated with temozolomide, which is the current standard of care for GBM.
Monday August 29, 2005
Peregrine Pharmaceuticals, Inc. and the New Approaches to Brain Tumor Therapy (NABTT) Consortium today announced the initiation of a clinical trial designed to confirm the dosing, safety and efficacy of a single intratumoral infusion of Cotara® in the treatment of glioblastoma multiforme (GBM), a common and deadly form of brain cancer.
The National Cancer Institute-approved protocol titled, "An Open-Label, Dose Confirmation and Dosimetry Study of Interstitial 131I-chTNT-1/B (Cotara®) for the Treatment of Glioblastoma Multiforme at 1st or 2nd Relapse," will evaluate safety, radiation exposure and efficacy of a single dose of Cotara®. The study represents the first part of Peregrine´s FDA-approved product registration clinical trial for Cotara®.
The trial will enroll patients at four NABTT institutions; Wake Forest University, Emory University, University of Alabama at Birmingham and University of Pennsylvania. Up to 28 patients will be enrolled in this trial.
"Glioblastoma multiforme is an aggressive and fatal cancer with few treatment options, and we are anxious to evaluate this novel study drug in patients," said Dr. Kevin Judy of the University of Pennsylvania, the Neurosurgery Chair for the study.
About Glioblastoma Multiforme
Glioblastoma multiforme (GBM) is the most common and clinically aggressive brain cancer and is associated with a grave prognosis. Approximately 80% of patients relapse within 6-12 months after treatment, with an overall median survival time for patients with newly diagnosed GBM of approximately 12 months.
In 2004, the American Cancer Society estimated that 18,400 new cases and 12,690 deaths were attributed to primary malignant brain (e.g. GBM) and central nervous system cancers in the U.S. Current therapeutic modalities include surgery, radiotherapy, and chemotherapy. However, most glioblastomas cannot be completely resected or irradiated due to the infiltrating fingers of tumor that characterize their growth. Additionally, the "blood-brain barrier" prevents most chemotherapeutic agents from reaching the tumor at therapeutic concentrations.
About Cotara® in the Treatment of Brain Cancer
Cotara® is the registered trademark for a chimeric tumor-necrosis therapy (TNT) antibody attached to Iodine-131, a radioactive agent. Cotara® is designed to bind to the dead or dying tissue present in virtually all solid tumors. Using this necrotic core as a stable anchorage, Cotara® delivers a cytotoxic radioisotope to the heart of the tumor, irradiating and killing nearby, living tumor cells.
In a prior phase 2 study, a subset analysis of recurrent GBM patients who received a therapeutic dose of Cotara® between 1.25 and 2.5 mCi/cc of tumor volume demonstrated a 58% improvement in median survival (38 versus 24 weeks) compared to patients treated with temozolomide, which is the current standard of care for GBM.
Mario[a]
