Thursday, March 16, 2023 7:21:33 PM
For non GBM solid tumors, patients were treated with DCVax-L not direct.
The patients could from US, UK or EU.
In the case of the US, as long as NWBO agrees to provide the vaccine, FDA has no problem approving its use. Same for UK and EU. Now Sawston was granted approval to produce the vaccine for compassionate use. I cannot imagine how many patients are going to apply for compassionate use. With no side effects at all, every patient would love to give it a try.
Here we can see the vaccine is for solid tumors.
"Northwest Biotherapeutics (OTCQB: NWBO) (“NW Bio”), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, today announced commencement of production of its first dendritic cell cancer vaccine for a compassionate use patient at its recently licensed production facility in Sawston, UK"
It just happened that the first production was for a GBM patient.
"Since the issuance of the MHRA license, Advent Bioservices, NW Bio’s contract manufacturer in the UK, has been conducting the required post-approval re-validations and testing so that the facility is now ready for the manufacture of cell therapy products for clinical use. Accordingly, the first vaccine production for compassionate use treatment for a glioblastoma patient has now begun in the Sawston facility."
https://nwbio.com/northwest-biotherapeutics-announces-commencement-of-cancer-vaccine-production-at-its-sawston-uk-facility/
https://www.fda.gov/drugs/investigational-new-drug-ind-application/physicians-how-request-single-patient-expanded-access-compassionate-use
https://ggcmedicines.org.uk/media/uploads/policies/section_9/9.3_compassionate_access_to_ulm_-_1502.pdf
https://www.ema.europa.eu/en/human-regulatory/research-development/compassionate-use
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