After months of research devoted to finding the connection between cancerous patients developing infections and their own remission, Coley decided to pursue his notion that such recoveries, considered miraculous at the time, were provoked by an
immune response in the body's immune system. In 1891, he began his experiments on a patient named Zola, an Italian immigrant and drug-addict with a life-threatening tumor which he described as "the size of a small hen's egg" in Zola's right tonsil. Hoping to spawn a similar case of remission that he had been studying for the past year, Coley attempted to induce a response by Zola's immune system by injecting
Streptococcus, a bacterium known to induce erysipelas attacks, directly into his tumor. Five months and several trials of injection later, Zola finally developed full-blown erysipelas infection. The tumor once thought to be irreversible then began to dissolve, disappearing within two weeks. Zola recovered and lived another eight years, before eventually succumbing to a recurrence of the tumour Two years after Zola's initial treatment, Coley treated ten more of his own patients with the same live
Streptococcus bacteria. Because of the unpredictable nature of infection, which killed patients of his on two separate occasions, Coley changed the bacterial ingredients of what would be coined
Coley's toxins from the live
Streptococcus bacteria, to two dead bacteria,
Streptococcus pyogenes and
Serratia marcescens. The formula change to the use of dead bacteria drastically reduced the risk of death in patients; however, Coley's toxins still remained controversial in the medical community. The passing of the 1962
Kefauver Harris Amendment, however, required Coley's toxins to be labeled as a "new drug" by the
Food and Drug Administration. It was this final blow to Coley's life work that drastically reduced the use of the concoction for cancer treatment. Since its changed status under the FDA, it has only been able to be prescribed through experimental clinical trials, which have continuously produced mixed results. == Effectiveness ==