Drafting an email to GBM AGILE - here is the gist of my email. I...

Drafting an email to GBM AGILE - here is the gist of my email. I will present the final draft here later on the chatline. You can see - the point I am making is well defined and specific.

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GBM AGILE contradict themselves - in that the wording preamble on their website.... makes reference to potential studies of drugs in combination - but there is no scope, or reference to these  combined studies in their own flow sheet.

I think the paxalisib study at GBM AGILE, probably replicated the actual FDA Phase 1 and 2 study - that is what would be expected.

You can see below...that post the FDA trials (and, as I say, probably GBM AGILE).....paxalisib is now ready for combination development. Yet all we hear from GBM AGILE - is the drug has not reached Stage 2. We probably knew even before GBM AGILE started (see Dr Dunns research) it was never going to be an FDA approach as a mono therapy - pointless therefore also for pax to go to that stage 2 GBM stage.

So GBM AGILE - what of the possibility of paxalisib now for combination studies - EXACTLY as you suggested may or could happen with drugs in your study.

How about better communication from you GBM AGILE - COULD YOU PLEASE EXPLAIN YOURSELVES. Either change your spreadsheet ...or remove reference to your own program possibly taking these drugs to combination (I trust it wont be the latter).

Clearly I am questioning your processes here GBM AGILE....you need to do better. Unnecessary destruction of the stockmarket worth of companies, who support your study - is not your intention, I presume.


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In this study, Dr. Dan will test the effectiveness of a combination of drugs identified for the treatment of DMG. One of the drugs, paxalisib, was discovered by Dr. Dan for the treatment of DMG / DIPG when his daughter was diagnosed. The combination of paxalisib and the second drug, ONC201, has shown promising results in the laboratory and in some compassionate access cases worldwide. “We knew how insidious this type of childhood brain stem glioma was and the foreign language used in cancer was to provide DMG children with long-term successful results. Turned out that one drug was enough, “Dr. Dan said. , “But if you use paxalisib as the backbone and combine it with other brain-penetrating drugs, the treatment really works


Abstract

Combination therapy, a treatment modality that combines two or more therapeutic agents, is a cornerstone of cancer therapy. The amalgamation of anti-cancer drugs enhances efficacy compared to the mono-therapy approach because it targets key pathways in a characteristically synergistic or an additive manner. This approach potentially reduces drug resistance, while simultaneously providing therapeutic anti-cancer benefits, such as reducing tumour growth and metastatic potential, arresting mitotically active cells, reducing cancer stem cell populations, and inducing apoptosis.