Saturday, February 04, 2023 12:40:47 AM
"The results are intriguing; yet, it remains to be demonstrated that the effect observed is truly due to DCVax rather than a mere reflection of patient selection. There is a strong movement to allow for synthetic controls to replace randomized trials and limit the number of patients to be treated as controls, particularly in diseases like glioblastoma, where better treatments are urgently needed and progress has been slow. But, what magnitude of an effect do we want to see by accepting historical external controls in lieu of randomized trials for proof of efficacy? Being too stringent carries the risk of rejecting a potentially effective treatment strategy that could ultimately unfold its full potential if used in an optimized context or in combination, whereas criteria that are too relaxed will expose patients to ineffective treatments, toxicity, and costs and will ultimately hamper the development of more effective innovative therapies."
GBM is rare disease with hugely unmet need. Given DCVax impeccable safety profile utterly unheard of before, FDA approval is a complete no-brainer. But it is the last hope for the shorts.
Here is something interesting about Jedd D. Wolchok who is an medical oncologist and is one of keynote speakers at Frontiers in Cancer Immunotherapy 2023. Why do I mention him?
He wrote a paper published on Nature with Dr. Samir N. Khleif who was the member of NWBO Scientific Advisory Board. It could mean nothing. But it is fun to know.
https://www.nature.com/articles/s41590-019-0441-y
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