CNS Pharma Orphan Status for Berubicin

FDA has granted CNS Pharmaceuticals an orphan drug designation for its lead product berubicin for treating malignant gliomas. The designation is partially based on Phase 1 data showing that 44% of patients treated with berubicin demonstrated a significant improvement in progression free survival, and one patient experienced a complete response. A Phase 2 trial evaluating the effect of berubicin on patients with glioblastoma is planned for later this year, according to the company.

Berubicin is an anthracycline, a class of anticancer agents that are among the most powerful chemotherapy drugs and effective against more types of cancer than any other class of chemotherapeutic agents, CNS says. Anthracyclines are designed to utilize natural processes to induce DNA damage in targeted cancer cells by interfering with the action of topoisomerase II, a critical enzyme enabling cell proliferation, it explains.