It is interesting because PTCL and CTCL are the main subsets of TCL and both have shown durabilitiy beyond the SOC and even beyond that deemed to be a target for a registrational trial approval.
What was highlighted and given some context is the fact that "The nature of PTX-100’s efficacy observations seem unique. Other TCL drugs only achieve durability when they achieve CR, which is a rare event. By contrast, PTX-100 patients experienced durability even with PR and SD" Steven wasn't prepared to speculate on this, nor was he prepared to speculate on why the FDA granted PTX-100 the broader Orphan Drug Designation for all TCLs when PTX approached them for ODD for CTCL at the time.
The fact that TCL consists of a bunch of rare indications and AITL happens to be a type of peripheral T-cell lymphoma. It has nearly a 70% frequency rate of the Rho-A mutation, which is significant. Of the two subsets of TCL, Peripheral TCL is more aggressive than Cutaneous TCL. That to me suggests that PTX-100 warrants a separate trial for PTCL akin to a mixed label or basket study of different TCLs and that perhaps the sweet spot for the optimal dosage has yet to be identifiied for PTCL patients. I don't know, but perhaps the Ph1 ORR and CBR rates are compelling enough for the likes of Prof Miles Prince or Peter Mac to run a separate Ph2 trial in parallel to the one PTX commits to as a registrational trial.
The safety profile opens up all sorts of doors for PTX-100 including combo trials. I always get the impression that SYC is under the pump (from Top SH) to pursue the avenue which presents as the best value for money - that which will get us to the finishing line on the least possible outlay. So, we could well need the financial support to further investigate the potential of PTX-100 across the broader T-cell Lymphoma cancer group. A good problem to have but not an easy one to resolve.
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