Clinical stage oncology company Prescient Therapeutics (ASX:PTX) has announced the US FDA has granted PTX-100 a Fast Track Designation for the treatment of adults with relapsed or refractory mycosis fungoides, the most common subtype of Cutaneous T Cell Lymphoma.
PTX-100 is a first-in-class compound that can block a cancer growth enzyme known as geranylgeranyl transferase-1 (GGT-1). It disrupts oncogenic Ras pathways by inhibiting the activation of Rho, Rac and Ral circuits in cancer cells, leading to death of cancer cells. PTX- 100 is believed to be the only GGT-1 inhibitor in the world in clinical development.
Fast Track is a process designed by the FDA to expedite the review of therapies that treat serious conditions with a high unmet need, with the aim of getting therapies to patients earlier. It provides several benefits, including increased access to the FDA, the possibility of rolling submissions of New Drug Applications and a pathway to Accelerated Approvals.
Prescient Therapeutics CEO James McDonnell said, “Getting Fast-Track designation is a critical milestone towards our goal of advancing PTX-100 into a registration-enabling trial designed to support potential accelerated approval and, from there, commercialisation. As we progress our Phase 2 trials, we will be engaging closely with the FDA to ensure alignment on endpoints and study scope.”