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Monday, May 20, 2024 6:10:03 PM
I would not be surprised if the CRI website were correct, or if it were wrong, but I take their expertise more seriously than anonymous posters on the internet.
Here is the second reference to being approved: https://www.cancerresearch.org/cancer-types/skin-cancer
Poly ICLC (Hiltonol®): an immune adjuvant targeting the Toll-like receptor 3 (TLR3) pathway; approved for subsets of patients with squamous cell carcinoma
I note it also in both places references the other adjuvant that UCLA used, in both places, as already approved as well, for a small subset of patients, AS AN ADJUVANT.
Imiquimod (many brand names): an immune adjuvant targeting the Toll-like receptor 7 (TLR7) pathway; approved for subsets of patients with basal cell carcinoma
So I don't think we're going to see a standalone "approval" in the larger sense for poly-iclc ever. But I also don't think that means it won't be available as an adjuvant for vaccines and immunotherapies where it is shown to, as a PAMP, generate a strongly beneficial immune response that enhances a given treatment. The Nature story suggests that and of course it is part of the standard of care in the other UCLA trial that includes DCVax-L, Poly-ICLC and the trial adds the "factor X" in that case, which is an already approved drug, Keytruda, to see if adding Keytruda has a beneficial impact. Now why would a regulator allow a trial introducing poly-ICLC as part of the standard of care, not the factor x, in a trial, to see if Keytruda added a benefit? Seems kind of odd.
I own NWBO. My posts on iHub are always posted expressly as just my humble opinion (IMHO) and none are advice, just my opinion. I am NOT a financial advisor, and it is assumed that everyone is responsible for their own due diligence.
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