Orbus Therapeutics

The STELLAR Study is a Phase 3 study to evaluate the efficacy and safety of Eflornithine in combination with Lomustine compared to Lomustine alone in patients with Anaplastic Astrocytoma that progress/recur after irradiation and adjuvant temozolomide chemotherapy. Ornithine decarboxylase, or ODC regulates polyamine synthesis and is essential for cell division and differentiation Eflornithine is an irreversible inhibitor of ODC, inhibiting cell growth and proliferation.
With over 390 patient exposures across multiple Phase 1, 2 and 3 studies, Eflornithine has demonstrated meaningful increases in survival when in combination with standard of care chemotherapy up front and as a single agent in recurrent disease. This data enabled us to receive breakthrough designation by the FDA and orphan designation both in the US and EU.In order to be eligible, patients must have surgical or biopsy proven diagnosis of WHO grade 3 AA and have experienced their first tumor progression post EBRT and Temozolomide therapy.
The STELLAR Study is currently open and enrolling patients in approximately 90 sites across 8 countries including United States, Canada, Italy, Germany, Netherlands, Belgium, France and the UK.


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