Thursday, September 07, 2023
Orbus Therapeutics Inc., a privately held biopharmaceutical company specializing in late-stage drug development for rare diseases, has announced a significant milestone today. The company has successfully initiated patient enrollment for its Phase 1b clinical trial, which combines temozolomide and eflornithine as a potential treatment approach for individuals newly diagnosed with glioblastoma.
Presently, Orbus Therapeutics is actively conducting a Phase 3 clinical trial named the STELLAR study. This trial aims to assess the effectiveness of their eflornithine oral solution in patients with anaplastic astrocytoma who have experienced a recurrence of their cancer following radiation and adjuvant temozolomide chemotherapy. The launch of the Phase 1b study reflects Orbus' ongoing commitment to developing innovative treatment options for those affected by malignant gliomas.
Bob Myers, Co-Founder and Chief Executive Officer of Orbus Therapeutics, expressed enthusiasm about this development, stating, "While we are currently assessing the combination of eflornithine and lomustine in the ongoing randomized Phase 3 STELLAR study to enhance overall survival in patients with second-line or recurrent anaplastic astrocytoma, we are very excited to commence this new study of eflornithine in conjunction with temozolomide for patients with newly diagnosed glioblastoma."
Dr. Howard Colman, an expert in neuro-oncology at the Huntsman Cancer Institute at the University of Utah, emphasized the importance of this trial. He explained, "This is a pivotal trial evaluating the safety of combining eflornithine with temozolomide following surgery and radiation in patients newly diagnosed with glioblastoma. The results of this trial will provide crucial insights into the dosing combination of eflornithine with temozolomide for newly diagnosed glioblastoma patients, building on the progress of the ongoing Phase 3 trial for patients with recurrent anaplastic astrocytoma. Temozolomide is currently the standard of care for newly diagnosed glioblastoma patients."
The Phase 1b study has been designed as an open-label, single-arm clinical trial with a focus on assessing dose-limiting toxicity. It will involve approximately eight leading neuro-oncology clinical trial centers in the United States. The primary objective of the trial is to evaluate the safety and pharmacokinetics of eflornithine when combined with temozolomide. Eligible participants for this trial are individuals who have recently undergone surgery and radiation for newly diagnosed glioblastoma.
Orbus Therapeutics plans to enroll up to 60 participants in the Phase 1b study, using a "3 + 3" dose escalation design. Primary endpoints will encompass the assessment of dose-limiting toxicity and adverse events, while secondary endpoints will include evaluating progression-free survival (PFS), objective response rate (ORR), and pharmacokinetics.
Eflornithine is a novel cytostatic agent known for its irreversible inhibition of ornithine decarboxylase, a critical enzyme in mammalian polyamine biosynthesis, particularly up-regulated in certain cancer types.
Eflornithine has received recognition, including Orphan Drug Designation and Breakthrough Therapy Designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with anaplastic glioma. Additionally, it has been granted Orphan Medicinal Product status for glioma treatment by the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA).