Istari wins orphan drug designation for melanoma therapy

By The Science Advisory Board staff writers

January 11, 2021 -- The U.S. Food and Drug Administration (FDA) has granted orphan drug designation to Istari Oncology for its PVSRIPO technology as a treatment for stage IIB-IV melanoma.

PVSRIPO is a viral immunotherapy based on the Sabin type 1 polio vaccine. It activates the immune system to promote an antitumor response and prevent cancer's return and showed promising clinical results in a phase I clinical study.

The orphan drug designation is the first for Istari in 2021. Istari intends to continue developing PVSRIPO for multiple indications, and the company anticipates hitting more milestones later in the year.

Istari is currently recruiting patients for Luminos-102, a phase II randomized clinical trial to study the use of a PVSRIPO intratumoral injection in patients with advanced, unresectable melanoma who have failed anti-programmed cell death 1 (PD-1) therapy. The company plans to dose its first patient in the trial in the first quarter of this year.

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