Prescient Therapeutics Ltd (ASX:PTX, OTC:PSTTF) earlier this week began its Phase 2A clinical trial of PTX-100 in patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL). CEO James McDonnell talked with Proactive about the initiation.
The company said the first patient has been dosed in the study, following earlier successful results from a Phase 1B trial. PTX-100 is described as a first-in-class inhibitor of geranylgeranyl transferase-1, targeting the Ras pathway—a signalling mechanism implicated in over 20% of cancers.
Highlights
- Prescient Therapeutics has started a Phase 2A clinical trial for PTX-100 targeting relapsed or refractory CTCL.
- The first patient has been dosed, marking a significant trial milestone.
- PTX-100 is a first-in-class inhibitor of geranylgeranyl transferase-1, disrupting the Ras family pathway.
- The treatment has shown promising response rates and a favorable safety profile in Phase 1B.
- The trial will be conducted internationally to support future commercialization goals.
- The FDA has granted both orphan drug and fast track designations to PTX-100.
- Orphan status could provide seven years of market exclusivity after regulatory approval.
- Prescient is also considering PTX-100’s use in peripheral T-cell lymphomas and possibly other Ras-related cancers.
Favourable safety profile
Prescient highlighted that PTX-100 showed a favourable safety profile and promising response rates in earlier trials. It said many current CTCL treatments come with serious adverse effects, adding to patient fragility, while PTX-100 may offer a more tolerable alternative.
The trial will include up to 40 patients and will run across multiple international sites. The company said this approach supports global regulatory and commercial pathways.
Orphan drug and fast track designations
Prescient has secured orphan drug and fast track designations from the FDA. It noted that orphan status could provide seven years of market exclusivity starting at marketing authorisation, while fast track designation may accelerate the development process.
McDonnell said the company remains focused on CTCL but is also exploring applications in other T-cell lymphomas and Ras-involved cancers.
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