- The Phase 1 Study will Evaluate Eflornithine in Combination with Temozolomide -
PALO ALTO, Calif., September 6, 2023 – Orbus Therapeutics Inc., a private, late-stage biopharmaceutical company focused on the development and commercialization of therapies that treat rare diseases, announced today that the first patient has been enrolled in its Phase 1b study combining temozolomide and eflornithine in patients newly diagnosed with glioblastoma.
Orbus Therapeutics is currently conducting a Phase 3 clinical trial, referred to as the STELLAR study, to evaluate its eflornithine oral solution in patients with anaplastic astrocytoma whose cancer has recurred following radiation and adjuvant temozolomide chemotherapy. The initiation of this Phase 1b study is part of Orbus’ ongoing efforts to develop a new treatment option for patients with malignant glioma.
"While we are evaluating the combination of eflornithine and lomustine in the ongoing randomized Phase 3 STELLAR study to improve overall survival in patients with 2nd line or recurrent anaplastic astrocytoma, we are very excited to start this new study of eflornithine combined with temozolomide in patients with newly diagnosed glioblastoma,” said Bob Myers, Co-Founder and Chief Executive Officer of Orbus Therapeutics.
“This is an important trial evaluating the safety of eflornithine combined with temozolomide after surgery and radiation in patients with newly diagnosed glioblastoma,” said Howard Colman, MD, PhD, FAAN, the Jon M. Huntsman Presidential Chair in Neuro-Oncology at the Huntsman Cancer Institute at the University of Utah. “The results of this trial will provide important information on the dosing combination of eflornithine with temozolomide, in patients with newly diagnosed glioblastoma, and will build on the progress of the ongoing Phase 3 trial in patients with recurrent anaplastic astrocytoma. Temozolomide is the current standard of care in patients with newly diagnosed glioblastoma.“
The Phase 1b study is an open-label, single arm, dose-limiting toxicity clinical trial that will include approximately 8 leading neuro-oncology clinical trial centers in the United States. The trial is designed to evaluate the safety and pharmacokinetics of eflornithine in combination with temozolomide in patients with newly diagnosed glioblastoma who have completed surgery and irradiation.
The Company plans to enroll up to 60 subjects into the Phase 1b study. Participants in the study will be assigned into cohorts according to a standard “3 + 3” dose escalation design. The primary endpoints are the assessment of dose-limiting toxicity and adverse events. Secondary endpoints include progression free survival (PFS), objective response rate (ORR) and pharmacokinetics.
For more information about the trial, including enrolling centers, please visit
www.clinicaltrials.gov (NCT05879367).
About Eflornithine
Eflornithine is a novel cytostatic agent that irreversibly inhibits ornithine decarboxylase, a key enzyme in mammalian polyamine biosynthesis that is up-regulated in certain types of cancer.
Eflornithine has been granted Orphan Drug Designation and Breakthrough Therapy Designation for the treatment of patients with anaplastic glioma by the U.S. Food and Drug Administration (FDA), and has also been granted Orphan Medicinal Product status for the treatment of glioma by the Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMA).
About Orbus Therapeutics
Orbus Therapeutics Inc. is a late-stage, private biopharmaceutical company that is dedicated to developing products that treat rare diseases for which there are few, if any, effective therapies. The Company’s lead product candidate, eflornithine, is being evaluated in a pivotal Phase 3 clinical trial in patients with recurrent anaplastic astrocytoma, a rare form of central nervous system cancer. For more information, please visit the Company's website at http://www.orbustherapeutics.com.
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Source: Orbus Therapeutics, Inc.
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