FDA grants 'orphan' designation to PTX-100 for broader TCL indications

Latest News

Clinical-stage oncology company Prescient Therapeutics (ASX:PTX) has announced that the US FDA has granted Orphan Drug Designation for PTX-100 for the treatment of T-cell lymphomas (TCL), including cutaneous TCL (CTCL).

Having separately received the designation for peripheral TCL (PTCL) in 2022, Prescient said applied for ODD for CTCL.

"The FDA has now granted a broader designation than Prescient requested, which encompasses all TCLs," said the company.

TCLs describes a group of lymphomas that develop when a group of white blood cells called lymphocytes grow out of control. There are different groups of TCL, including PTCL and CTCL, each with several distinct subtypes.

This ODD designation now covers all TCLs and their subtypes.

Prescient managing director and CEO Steven Yatomi-Clarke said, “Prescient is delighted to be granted this Orphan Drug Designation by the FDA, and is pleasantly surprised for the granting of the designation that is broader than our request. This now confers the certainty of 7 years of market exclusivity for PTX-100 in a broader range of diseases with unmet or poorly met clinical need. We look forward to sharing updates on the PTX-100 trial shortly.”