Research & Development
Bioniz Therapeutics' BNZ-1 receives European Commission orphan designation
7 April 2021 -

Bioniz Therapeutics Inc, a clinical-stage biopharmaceutical company, announced on Tuesday that it has received orphan designation from the European Commission for its BNZ-1, intended for the treatment of cutaneous T-cell lymphoma (CTCL), a rare skin cancer.

Orphan designation from the EC provides incentives for companies to develop medicines intended for the treatment, prevention, or diagnosis of a disease that is life-threatening or chronically debilitating and where no satisfactory treatment is currently authorised. The product had earlier received orphan drug designation from the United States Food and Drug Administration (FDA).

The company has completed a phase two study of BNZ-1 in cutaneous T-cell lymphoma in the United States and aims to start a phase three clinical trial of the product intended for the treatment of patients with relapsed or refractory CTCL. It is likely to start enrolling for the phase three trial in the second half of 2021.

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