Orbus Therapeutics Announces ASCO Study Design Presentation of Pivotal Clinical Trial in Patients with Late-Stage Brain Cancer

PALO ALTO, Calif., June 05, 2017 (GLOBE NEWSWIRE) — Orbus Therapeutics Inc., a private, clinical-stage biopharmaceutical company focused on the development and commercialization of therapies that treat rare diseases, today announced that an abstract detailing the trial design of the STELLAR study has been accepted for presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place June 2 to 6, 2017. The STELLAR study is an ongoing pivotal Phase 3 clinical trial of eflornithine in patients with anaplastic astrocytoma whose cancer has recurred following radiation and adjuvant chemotherapy.

“We have made considerable progress towards initiating the majority of our planned clinical trial sites so that we can make this clinical trial as widely available as possible to patients with recurrent anaplastic astrocytoma,” said Victor Levin, M.D., founder of the Society of Neuro-Oncology, and Chairman of Orbus’ Clinical Advisory Board. “We believe that clinicians and patients need better therapies for this devastating disease, and we are hopeful that the STELLAR trial may lead to meaningful improvements in survival outcomes.”

The abstract, entitled “STELLAR: A phase 3, randomized, open-label study of eflornithine with lomustine vs lomustine for patients with first recurrence of anaplastic astrocytoma after RT and adjuvant temozolomide” will be presented in a poster session on Monday, June 5th from 1:15 to 4:45pm CT.

About the STELLAR study
The Phase 3 STELLAR study is a randomized, open-label, controlled clinical trial that has already initiated 52 of the planned 75 leading clinical trial centers in North America and Europe. The trial is designed to evaluate the efficacy and safety profile of eflornithine in combination with lomustine compared to lomustine alone in patients with anaplastic astrocytoma that recurs after surgery, irradiation and adjuvant temozolomide chemotherapy. Median survival of recurrent anaplastic astrocytoma patients treated with lomustine has been reported to be between 9 and 10 months.

The Company plans to enroll approximately 280 patients into the STELLAR trial. Participants in the trial will be randomized at a 1:1 ratio into two treatment arms: eflornithine plus lomustine versus lomustine alone. The primary efficacy endpoint in the STELLAR trial is the duration of overall survival (OS). Secondary pre-specified efficacy endpoints include progression free survival (PFS) and objective response rate (ORR). For more information about the trial, including enrolling centers, please visit www.clinicaltrials.gov (NCT02796261).

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 3,600 new cases of anaplastic glioma, one of two categories of malignant glioma, are diagnosed each year with a median survival of just over three years despite treatment with surgery, radiation and chemotherapy.

The prevalence of anaplastic astrocytoma in the United States is estimated to be just over 9,000 people. Anaplastic astrocytoma is the largest subset of anaplastic glioma, and represents approximately 75 percent of anaplastic glioma patients. It is estimated that there are more than 3,300 new anaplastic astrocytoma cases diagnosed in the United States each year.

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.

The Company is conducting STELLAR, A Phase 3, Randomized, Open-Label Study To Evaluate the Efficacy and Safety of Eflornithine Lomustine Compared to Lomustine Alone in Patients with Anaplastic Astrocytoma That Progress/Recur After Irradiation and Adjuvant Temozolomide Chemotherapy.

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 private, clinical-stage 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 in clinical development is eflornithine, which the Company is developing to treat 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

CONTACT: Investor Contact:
Jason Levin, COO

Media Contact:
Denise Powell