Clinical-stage oncology company Prescient Therapeutics Ltd (ASX:PTX, OTC:PSTTF) has been invited to present PTX-100 Phase 1b results at the 15th Annual T-Cell Lymphoma Forum (TCLF) to be held in California from June 6 to 8.
Primary goals met
The Phase 1b study of PTX-100, which targeted patients with relapsed and refractory T-cell lymphomas (r/r TCLs), has met its primary goals of demonstrating safety and determining both pharmacokinetics – how the drug is absorbed, distributed, metabolised and excreted in the body – and pharmacodynamics, or the effects of the drug on the body.
Additionally, the study has shown promising preliminary efficacy in r/r TCL patients, surpassing the typical results expected from standard treatments, with an overall response rate of 45%.
This means that five out of 11 evaluable TCL patients responded positively to the treatment.
Orphan disease designation
T-cell lymphomas (TCLs) are a type of non-Hodgkin lymphoma that originates from T-cells, a kind of white blood cell.
TCLs are considered an orphan disease, which means they are rare, with around 30,000 cases. There is a significant need for more effective treatments for TCLs, especially for those with relapsed and refractory disease.
Accordingly, PTX-100 has been granted Orphan Drug Designation by the US Food and Drug Administration (FDA), a status given to drugs intended for the treatment of rare diseases.
The 15th annual T-Cell Lymphoma Forum (TCLF) is a specialised conference focusing on the latest and most significant advancements in T-cell lymphomas, including new agents and treatment approaches.
It brings together clinicians, scientists and industry professionals dedicated to TCLs.
The PTX-100 study results will be presented in a plenary address by the study's Principal Investigator, Professor H. Miles Prince, AM, a distinguished haematologist and globally recognized expert in TCLs.
Esteemed platform
Prescient Therapeutics managing director and CEO Steven Yatomi-Clarke said: “The TCLF is an esteemed platform for sharing the latest research and developments in the field of TCLs.
“To be invited to present our data in a coveted slot to world leaders in the field of TCLs showcases the relevance and potential of PTX-100 in this area of unmet need.
“It also highlights the momentum and standing that Prescient has in this specialised community of TCL clinicians and drug developers, having previously presented at the American Society of Hematology 65th Annual Meeting and the 5th World Congress of Cutaneous Lymphomas.
“Prescient is committed to advancing into a Phase 2 trial in r/r TCL, with the study aiming to commence in Q3 2024. The company believes this will be a big catalyst for Prescient, potentially offering a new beacon of hope for patients with limited treatment options.”