Prescient Therapeutics Ltd.'s (PTX.AX) investigational drug PTX-100 has been granted Orphan Drug Designation by the European Medicines Agency for the treatment of cutaneous T-cell lymphoma in both mycosis fungoides and Sezary syndrome subtypes.
Cutaneous T-cell lymphoma, or CTCL, is a rare type of non-Hodgkin lymphoma, a cancer that starts in the lymphatic system, in which cancerous T cells, a kind of white blood cell, primarily grow in the skin. Mycosis fungoides is the most common type of cutaneous T-cell lymphoma, a cancer that starts in the skin, and Sézary syndrome is an aggressive form of cutaneous T-cell lymphoma that involves the skin, blood, and lymph nodes.
PTX-100 is a compound with the ability to block a vital cancer growth enzyme known as geranylgeranyl transferase-1 or GGT-1, which disrupts oncogenic Ras pathways by inhibiting the activation of Rho, Rac and Ral circuits in cancer cells, leading to the death of cancer cells.
Notably, the US FDA has granted PTX-100 Orphan Drug Designation for all T Cell Lymphomas and Fast Track Designation for the treatment of adults with relapsed or refractory mycosis fungoides, the most common subtype of CTCL.
PTX-100 is currently in Phase 2a trials for relapsed/refractory CTCL.
The European Medicines Agency's (EMA) Orphan Drug Designation for PTX-100 offers substantial benefits upon approval, including 10 years of Protocol assistance and reduced fees for access to centralised marketing authorisation.
On Wednesday, the shares had closed 20.83% higher at A$0.0580 on the Australian Securities Exchange.
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