Phoenix, AZ, Sept. 10, 2022 (GLOBE NEWSWIRE) — The Ivy Brain Tumor Center at the Barrow Neurological Institute today announced top results from a Phase 0 clinical trial of pamiparib in newly diagnosed glioblastoma (GBM) and recurrent in association with radiotherapy therapy. Pamiparib is an investigational small molecule PARP inhibitor created by BeiGene, Ltd. PARP proteins play an important role in the cell survival response to DNA damage and compromise the effects of chemotherapy.
Interim analysis demonstrated that pamiparib is well tolerated in glioblastoma patients, reaches pharmacologically relevant concentrations in non-enhanced GBM tissues, and sensitizes brain tumor tissues to radiation ex-vivo.
Nader Sanai, MD, director of the Ivy Brain Tumor Center and director of neurosurgical oncology at the Barrow Neurological Institute, presented the findings during an oral session on CNS tumors at the European Society of Oncology Congress. medicine in Paris today.
“The initial results from this Phase 0 study of pamiparib plus radiation therapy are the first of their kind,” said Dr. Sanai. “This study is part of our programmatic efforts to identify drugs that can increase the effectiveness of radiation therapy for newly diagnosed and recurrent glioblastoma patients.”
The Ivy Center’s new Phase 0 study approach has demonstrated that pamiparib is able to penetrate the blood-brain barrier and reach the tumor at high levels, one of the most significant challenges in cancer treatment of the brain.
“Part of the reason new drugs haven’t emerged for glioblastoma for more than three decades is that the vast majority are unable to cross the blood-brain barrier and reach tumors in patients,” a- he declared. “This new phase 0 study offers another avenue of hope for glioblastoma patients and their families awaiting new effective therapies.”
The initiation of this study marked the first ever Phase 0 study to enroll newly diagnosed GBM patients, in addition to recurrent GBM patients to test PARP inhibitors. This is one of more than a dozen Phase 0 clinical trials the Ivy Center has initiated for patients with glioblastoma and other aggressive brain tumors.
The initial data is based on 20 newly diagnosed patients and 14 patients with recurrent glioblastoma who enrolled in the clinical trial and received study drug for four days before scheduled surgery to remove their tumors. Within days of opening, the Ivy Center team evaluated the drug’s pharmacokinetics and pharmacodynamics to determine its effects on each patient’s tumor. Nineteen patients with positive results moved on to the expansion phase of the study, which combines therapeutic dosing of pamiparib with radiation therapy.
Pamiparib is an experimental PARP1 and PARP2 inhibitor discovered by BeiGene scientists. Pamiparib has demonstrated PARP-DNA complex scavenging and brain penetration properties in preclinical models and is currently in worldwide clinical development as monotherapy or in combination with other agents for a variety of solid malignancies.
To learn more about this Phase 0 clinical trial, including eligibility criteria, visit https://clinicaltrials.gov/ct2/show/NCT04614909.
About the Ivy Brain Tumor Center
The Ivy Brain Tumor Center at the Barrow Neurological Institute in Phoenix, AZ, is a nonprofit translational research program that uses a bold strategy of early phase clinical trials to identify new treatments for aggressive brain tumors, including the glioblastoma. The Ivy Center’s Phase 0 clinical trial program is the largest of its kind in the world and enables personalized care in a fraction of the time and cost associated with traditional drug development. Unlike conventional clinical trials focused on single drugs, its accelerated trials program tests therapeutic combinations tailored to individual patients. Learn more at IvyBrainTumorCenter.org. Follow the Ivy Brain Tumor Center on Facebook, Instagram, Twitter and LinkedIn.
Director of the Ivy Brain Tumor Center and Director of Neurosurgical Oncology at the Barrow Neurological Institute