Orbus Therapeutics’ Phase 3 Eflornithine STELLAR Study Reaches Full Patient Enrollment

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PALO ALTO, Calif., Jan. 19, 2022 (GLOBE NEWSWIRE) -- Orbus Therapeutics Inc., a private, late-stage biopharmaceutical company focused on the development and commercialization of therapies that treat rare diseases, today announced that patient enrollment of its Phase 3 STELLAR clinical study of eflornithine in patients with recurrent anaplastic astrocytoma is complete. The STELLAR study completed full enrollment with a total of 343 patients.

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Wednesday, January 19, 2022
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Survival, Anaplastic astrocytoma, Ornithine decarboxylase, Safety, Overalls, EMA, European Medicines Agency, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Population, Lomustine, Achievement, CEO, Efficacy, GLOBE, Committee, Radiation, Isocitrate dehydrogenase, Glioma, Irradiation, IDH, PALO, Committee for Medicinal Products for Human Use, PFS, Therapy, Company, European Directive on Traditional Herbal Medicinal Products, Neuron, Cancer, OS, Food, CHMP, FDA, Brain, Prevalence, Trial of the century, ORR, Pharmaceutical industry, Medical imaging, Eflornithine, Patient
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NORTH AMERICA, EUROPE, ALTO, UNITED STATES
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ORBUS THERAPEUTICS, INC.
Summary
Key Points: 
  • PALO ALTO, Calif., Jan. 19, 2022 (GLOBE NEWSWIRE) -- Orbus Therapeutics Inc., a private, late-stage biopharmaceutical company focused on the development and commercialization of therapies that treat rare diseases, today announced that patient enrollment of its Phase 3 STELLAR clinical study of eflornithine in patients with recurrent anaplastic astrocytoma is complete.
  • The STELLAR study completed full enrollment with a total of 343 patients.
  • We are delighted to announce that we have completed enrollment of patients in the STELLAR study.
  • The STELLAR study is the largest randomized Phase 3 study that has been conducted in this patient population, said Bob Myers, co-founder and CEO.



- Phase 3 STELLAR trial evaluating eflornithine in patients with recurrent anaplastic astrocytoma -

- Pre-specified interim analysis to test for superiority expected to occur in 2022 -

PALO ALTO, Calif., Jan. 19, 2022 (GLOBE NEWSWIRE) -- Orbus Therapeutics Inc., a private, late-stage biopharmaceutical company focused on the development and commercialization of therapies that treat rare diseases, today announced that patient enrollment of its Phase 3 STELLAR clinical study of eflornithine in patients with recurrent anaplastic astrocytoma is complete. The STELLAR study completed full enrollment with a total of 343 patients.

“We are delighted to announce that we have completed enrollment of patients in the STELLAR study. The STELLAR study is the largest randomized Phase 3 study that has been conducted in this patient population,” said Bob Myers, co-founder and CEO. “This achievement represents an important milestone for our company toward our goal of bringing this new potential therapy to patients with recurrent anaplastic astrocytoma, a rare and fatal disease. We look forward to conducting an interim analysis for superiority in 2022.”

About the STELLAR study
The STELLAR study, a Phase 3, Randomized, Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine and Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy, started in late 2016 and has involved more than 85 leading clinical trial centers in eight countries in North America and Europe. The trial is designed to evaluate the efficacy and safety of eflornithine in combination with lomustine compared to lomustine alone in patients with anaplastic astrocytoma that recurs after surgery, irradiation and adjuvant temozolomide chemotherapy.

The primary efficacy endpoint in the STELLAR study is the duration of overall survival (OS). Secondary pre-specified efficacy endpoints include OS in isocitrate dehydrogenase (IDH) mutant and wild type sub-populations, progression free survival (PFS) and objective response rate (ORR). Find more information about the STELLAR study here.

About Anaplastic Glioma and Anaplastic Astrocytoma
Several brain tumor types are grouped together under the name glioma which originates in the glial cells that surround and support neurons in the brain. In the United States, greater than 2,000 new cases of anaplastic glioma, one of three grades of malignant glioma, are diagnosed each year. Despite treatment with surgery, radiation and chemotherapy, median survival for people with anaplastic glioma is just over three years. Anaplastic astrocytoma is the largest subset of anaplastic glioma, and represents approximately 75 percent of anaplastic glioma patients. Anaplastic astrocytomas typically require aggressive treatment and, due to tentacle-like projections that grow into surrounding tissue, are difficult to completely remove during surgery. It is estimated that there are more than 1,500 new anaplastic astrocytoma cases diagnosed in the United States each year. The prevalence of diffuse and anaplastic astrocytoma in the United States is estimated to be just over 23,000 people.

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. In controlled, randomized and single arm clinical studies, eflornithine has shown an increase in overall survival of patients with newly diagnosed or recurrent anaplastic astrocytoma.

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

Source: Orbus Therapeutics, Inc.

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