. Coley's is a natural treatment for cancer. It uses natural chemical substances, those produced by microorganisms, as the basis for the medication. The natural chemicals are thought to be 1) toxic to cancer cells, 2) strong stimulators of the immune system, and 3) inducers of fever, a natural from of internal hyperthermia therapy. Decades of use, plus recent clinical studies, suggest that Coley's is safe and effective.
Coley's vaccine has a long and interesting history. Once used as the mainstay in American oncology for bone and other cancers, Coley's fell into disuse after the advent of chemotherapy. Coley's vaccine has been known by various other names including Coley's fluids, Coley's toxins, Coley's Mixed Toxin, Coley's Mixture, Erysipelas and Prodigiosis Toxins, Febrivax, Multi Bacterial Vaccine, and Vaccineurin. MBVax Bioscience provides Coley Fluid for research and clinical study.
Coley Fluid was a mainstream cancer therapy for many years, but its use particularly in the United States declined with the advent of chemotherapy. In 1962, an amendment to the Pure Food and Drug Act established the present system of FDA approval. The amendment included a "grandfather clause" that legalized drugs currently being marketed. Unfortunately, in 1962 no U.S. companies were marketing Coley Fluid so in spite of a 70-year history of safe and effective use, beginning in 1962 Coley Fluid was no longer an approved therapy in the United States.
In 1982, researchers determined 5-year survival of historical Coley Fluid cancer patients was equivalent to 5-year survival of modern patients. In 1999, researchers found 10-year survival of historical Coley Fluid patients was better than modern sarcoma, kidney and ovarian cancer patients. In addition to prolonging survival, Coley Fluid was frequently curative in types of cancer that are incurable today.
William Coley, M.D. was a leading oncologist in 19th Century America. From the turn of that century until the 1930's his innovative cancer vaccine was arguably the leading form of cancer treatment in the United States. It was government approved, and accepted by leading hospitals in the USA. Dr. Coley and his cancer vaccine seem to have been ahead of their time. It all started when Dr. Coley treated a boy ill with a large abdominal malignant tumor. Every few days, Coley injected his fluid directly into the tumor mass and produced the symptoms of an infectious disease, but did not produce the disease itself. On each injection, there was a dramatic rise in body temperature and chills. The tumor gradually diminished in size. By May 1893, after four months of intensive treatment, the tumor was a fifth its original size. By August, the remains of the growth were barely perceptible. The boy received no further anticancer treatment and remained in good health until he died of a heart attack 26 years later.
Coley published his results and by the turn of the century 42 physicians from Europe and North America had reported cases of cancer that had been successfully treated with Coley Fluid. Coley Fluid became a mainstream cancer treatment and was successfully used in the treatment of most types of cancer. Until his death in 1936, Coley was the head of the bone tumor department at Memorial Hospital in New York City where he treated thousands of bone cancer patients with his fluid. In the United States the pharmaceutical company Parke Davis manufactured Coley Fluid until 1951.
The historical results of Coley Fluid therapy are difficult to compare with modern results. Even so, every published study has reached the same conclusion: Coley Fluid therapy is as good, or better, than modern therapies. However, there were many different formulations of Coley Fluid that varied greatly in effectiveness, and there were many different treatment protocols that also varied greatly in effectiveness. The company believes its Coley Fluid formulation and treatment protocol will be more effective than current therapies for a wide range of cancers.
Several studies have been done previously and point ot Coley's as being safe and effective. However, it must be noted that the manufacturer has not yet completed their studies (this study is one of those) and the product is not approved by the FDA. As with all new or modified old mediations, thorough tests and clinical trials are required. The following text, data, and charts are taken verbatim and without modification from the MBVax published materials. "A scientific review of 897 cancer patients treated with various formulations of Coley Fluid up to 110 years ago found that complete regression and 5-year survival occurred in 46% of the 523 inoperable cases and 51% of the 374 operable cases. These results are comparable to modern 5-year survival rates. The National Cancer Institute estimates overall 5-year cancer survival at 35% in 1950-54 and 63.8% in 1992-98.
To determine comparable rates of 10-year survival, in 1999 researchers compared Coley Fluid patients with matched controls from the National Cancer Institute's Surveillance Epidemiology End Result database. The study found higher rates of 10-year survival for Coley Fluid patients compared to modern patients in kidney cancer (33% to 23%), ovarian cancer (55% to 29%) and sarcoma (50% to 38%).
However, retrospective studies underestimate the efficacy of Coley Fluid because:
If Coley Fluid patients fared as well as modern cancer patients in spite of variations in formulation and clinical protocol, patients receiving an optimized version of Coley Fluid under a proper clinical protocol should fare even better.
To illustrate the importance of formulation, the chart below compares 5-year survival rate by formulation for 137 historical sarcoma patients who received Coley Fluid therapy:
To illustrate the importance of clinical protocol, the chart below compares 5-year survival rate by length of therapy for the same group of historical sarcoma patients:
There have been 63 cases of advanced breast cancer treated with Coley Fluid. Of these cases, the subsequent histories of the 37 patients who received effective formulations were significantly better compared to the 26 patients who received ineffective formulations.
In these charts, the column "apparent cure" refers to patients who had no evidence of disease at the time of their last known medical examination (average 7.8 years after therapy), and the column "more than 2" refers to patients who survived more than 2 years (average survival of these six patients was 8.1 years).
When the eventual fate of these 63 patients is considered in terms clinical protocol, patients treated for at least three months fared much better than those treated for less than three months.
Finally, when we analyze the subsequent histories of advanced breast cancer patients treated with both an effective version of Coley Fluid and for 3 months or longer, the results are very promising.
Since 1960, there have been six clinical trials of Coley Fluid. In these trials, Coley Fluid was tested in patients who were receiving or had previously been treated with chemotherapy and/or radiation therapy. In contrast, at MBVax Bioscience we will study Coley Fluid as a stand alone therapy, that is without the use of chemotherapy or radiation therapy which can suppress the immune system."
1962 - Johnston Trial - various cancers.
1981/83 - Kempin Trial - non-Hodgkin's lymphoma.
1988 - Axelrod Trial - various cancers.
1991 - Kolmel Trial - malignant melanoma.
1991 - Tang Trial - liver cancer.
1993 - Havas Trial - various cancers.
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