Phase II human study with vitamin B3 for brain cancer (glioblastoma)
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This type of cancer is one of the deadliest and even with treatment the prognosis is very poor. Low double digits survival rate after 5 years. This is the same type of cancer that killed Senators Kennedy and McCain. A few years ago, there was an animal study showing vitamin B3 greatly inhibits the growth of this cancer. It appears, Big Pharma took notes and is quietly switching to pro-metabolic therapies for cancer. At first, they will call it “adjuvant” therapy so that they don’t kill their blockbuster chemotherapy drugs. In a few years, we will probably see this patented vitamin B3 formulation promoted as a “paradigm shift” in cancer therapy and being promoted as the main/only treatment while cytotoxic therapy is quietly phased out. It looks like the daily dose will be around 2g daily, which is high but still below the dose of 3g shown to be the limit for no side effects in humans.
https://link.springer.com/article/10.1007/s11060-025-05351-z
“…Survival of patients with glioblastoma (GB) treated with standard of care (SOC) surgery, radiotherapy, and temozolomide is 15 months with progression free survival at 6 months (PFS-6 M) of 53.9%. In vivo studies showed increased survival in mice with GB treated with niacin. This is a first in human Phase I-II study aiming to evaluate safety and efficacy of controlled-release niacin (NiacinCRT
) added to SOC.Methods
Patients 18–75 years old with newly diagnosed glioblastoma eligible for SOC treatment were included. Phase I evaluated intra-patient dose escalation of niacin (500–3000 mg/d) to determine dose limiting toxicity (DLT), maximum tolerated dose (MTD) and recommended phase II dose (RP2D). Phase II aims to determine if niacin adds ≥ 20% absolute increase in PFS-6 M over historical controls. Interim/futility analysis was planned when 24 patients become evaluable for PFS-6 M. The study would stop if the conditional power (one-sided Z test) < 20% or futility index > 80%.
Results
Phase I included 15 patients; median age: 57 years (37–68), 40% women, and 47% with MGMT promoter methylated. The most common side effect was flushing (10/15; 9 grade 1). Two DLTs occurred at 2,500 mg/d niacin (grade 3 thrombocytopenia and hyperbilirubinemia). Niacin dose escalated up to 2000 mg/d is the ongoing RP2D. Interim analysis by central radiology review reported PFS-6 M of 82.3% (CI95% 82.14–82.46%).
Conclusion
The MTD dose of niacin added to first line treatment in patients with GB is 2000 mg/d. The interim analysis already showed an absolute increase in PFS-6 M of 28%.
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@haidut I recall back in ~2017 about B3 for glioblastoma. I knew somebody who died with it at the time and I was discussing niacinamide with their wife (but they were not doing anything other than what the doc told them sadly). Although, it wasn't until "treatment" when this individual rapidly declined and died within 6 months.
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@bio3nergetic
useful link
niacin and cancer
https://www.alternative-cancer-care.com/niacin-vitamin-b3-and-cancer.html -
@cedric good info
