– Patent relates to a solution of eflornithine for oral administration currently being evaluated in Orbus’ Phase 3 STELLAR study in rare brain cancer –
PALO ALTO, Calif., Dec. 23, 2020 (GLOBE NEWSWIRE) — Orbus Therapeutics Inc., a private, late-stage biopharmaceutical company focused on the development and commercialization of therapies that treat rare diseases, announced that it has been granted patent No. 10,786,470 entitled “Formulations for Administration of Eflornithine,” by the United States Patent and Trademark Office (USPTO).
The patent, which was granted on September 29, 2020, covers a solution of eflornithine hydrochloride hydrate for oral administration and methods of use for treating gliomas including anaplastic astrocytoma.
Orbus is currently evaluating eflornithine in an ongoing Phase 3 clinical trial, the STELLAR study, in patients with anaplastic astrocytoma whose cancer has recurred following radiation and adjuvant chemotherapy. 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 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 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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