Each shot would be completely personalized to the patient.
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Wagner’s TLPO cancer vaccine has been tested in hundreds of patients with advanced forms of melanoma in Phase 2 clinical trials.
The most recent data presented at an academic conference showed nearly 95% of people given only the vaccine were still alive three years after starting treatment and 64% were still disease-free. Among the most advanced forms of melanoma, disease-free survival after three years for people with stage III disease was 60% in the vaccine-only group, compared to about 39% in the placebo group. Disease-free survival for those with stage IV disease was about 68% in the vaccine-only group, and zero in the placebo group.
The most common side effects were redness or pain at the injection site, fever and fatigue after the injection – similar to other vaccines that stimulate an immune response.
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Based on this data and other studies, the Food and Drug Administration (FDA) has greenlit Wagner’s vaccine to start a Phase 3 clinical trial. It will be a three-year endeavor with a goal to enroll 500 people and is planned to launch sometime this year, Riley Polk, president of Orbis Health Solutions, told WLOS, an ABC News affiliate in Asheville, North Carolina.
I know it’s for scientific purpose and all, and they signed off on it, but what a bum fucking deal to get a placebo in that stage 4 group.
I’ve seen news of other experiments like this where once the treatment was so obviously working they flipped the placebo group over to the treatment as well out of compassionate grounds, but perhaps in this case the treatment is so expensive right now that they simply didn’t have the resources to do that. So perhaps they went “our grant allows us to produce at most X number of doses of the real treatment for this, so let’s take on 2X patients for it,” and ended up saving the largest number of people they could have.
In later trials, drugs aren’t compared against placebo, but a standard therapy regimen.