One thing is for sure, we are finally heading into an...

One thing is for sure, we are finally heading into an interesting time with PTX. The amount of R&D that must be going on in the background to provide PTX-100 with the best opportunity (in context of its broader applications) must be enormously challenging. The likelihood of PTX-100 presenting as a viable companion drug for cell therapy treatments could increase from this juncture.

The sort of biomarkers, though, I had in mind are those inside the cell and not so much on the surface such as CDs. Biomarkers specific to RhoA mutations (such as our own p27 and others) would provide predictive data. They could enhance the odds of Phase 2 approval as a registration trial if we have a few biomarkers in our trial design/s. This approach could streamline patient recruitment, targeting those most likely to respond and potentially accelerating market approval. Surrogate endpoints, based on positive molecular changes, serve as predictive tools in determining longer-term clinical data like duration and tumor regression sooner. Surrogate endpoints seem to be a key aspect of registration trials.

The high frequency of RhoA mutations in AITL and DGC, a solid gastric tumor, is intriguing. It wouldn't surprise me if our early Phase 2 data in PTCL and/or CTCL leads to a partnership to explore PTX-100 in DGC. Another interesting point is that AIT Lymphoma is a type of PTCL. The categorization of sub-types within TCL is confusing, but it would be beneficial if our PTCL recruitment included more AITL cases with a higher frequency of RhoA mutations to enhance our chances of bringing PTX-100 to the market.

And, who said I was never a fan of PTX-100? KISS (I like keeping it simple). Targeted therapies are simpler and cheaper compared to cell therapies. The safety profile of PTX-100 which is already termed "excellent" may even improve more if we are going to be treating patients in earlier stages of treatment.