Submission + - Potential cancer vaccine entering Stage 3 trials (go.com)
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.
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.
Perhaps the most startling success story is Mary Carol Abercrombie:
One of those patients is a woman named Mary Carol Abercrombie who Wagner believes is one of the longest surviving people previously diagnosed with stage 4 melanoma, the most advanced form of the disease. Just before Christmas in 2001, Abercrombie told WLOS she completed a year of cancer treatment with "horrendous" side effects but once the treatment stopped, her cancer advanced. Abercrombie said her doctors told her she only had a few more months to live, telling her to "just enjoy Christmas."
Abercrombie's surgical oncologist at the time was working with Wagner on a cancer vaccine. "Sign me up, 'cause there wasn't anything [else] out there," Abercrombie said, who was just hoping to live long enough to see her son get married that year. Over 20 years have since passed and Abercrombie said her melanoma has never recurred. She not only saw her son get married, but she's watching her four grandchildren grow up.