25 years ago, a Swedish microbiologist peered into a microscope to investigate how different components in breast milk fight bacteria-infected cells.
After some study, the scientist replaced the infected cells with tumor cells. Imagine her surprise when a certain fraction of the breast milk wiped out these tumor cells completely, killing the cancer.
The research shifted to answer the question, why does this milk fraction have such a dramatic cancer-killing effect? Five years later, she found the answer. Here’s what this discovery means for anyone who gets cancer.
In 1995, Professor Catharina Svanborg, from Lund University, Sweden, was searching for natural antibiotics. Human breast milk, with its proteins, antibodies and immune cells, seemed like a good place to start.
Together with her research team, Prof. Svanborg placed some lung cancer cells in a petri dish with the milk protein, alpha-lactalbumin.
When they saw the cells die, they were astonished. "We had to repeat it a few times before we could believe our eyes," exclaimed Prof. Svanborg. "It was a totally serendipitous discovery."
They published their findings and went on to carry out a great deal of laboratory study to find out what in particular caused this miraculous reaction and how.
By 2000 they discovered that under certain conditions the milk protein became folded or shaped in a special way. As a result, this altered its biological function.
This folding variant, in combination with a fatty component in breast milk called oleic acid, was shown to induce apoptosis (suicide) in tumor cells, while having no effect on healthy cells.
They named this protein-lipid complex HAMLET (human alpha-lactalbumin made lethal to tumor cells).
A new way to kill cancer
Further research revealed that in tumor cells the complex is able to penetrate the membrane of the cell and travel into the cytoplasm -- the material inside the cell but outside the nucleus -- where it targets the cell's energy factories, the mitochondria.
Once there it slashes energy production and causes the release of a protein that kickstarts the process that leads to apoptosis.
HAMLET also passes into the nucleus of the cell containing the DNA, where it accumulates and binds to proteins made there. By doing so, the professor explains, "it's a bit like pouring cement on these cells. They just can't make new molecules and survive any longer."
These processes only happen in a cancer cell because its membrane is more primitive. HAMLET takes advantage of this weakness, which enables it to insert itself into the membrane and move across it.
Prof. Svanborg calls the cellular studies "exhilarating" because her team tested more than 40 cancer cell lines including leukemia and lymphoma, and to her "great surprise" most died in a similar way, by apoptosis.
But what was really interesting was that the way apoptosis happened was different from the one cancer researchers are familiar with.
Apoptosis comes about through a series of particular steps. Yet with HAMLET these steps were not activated. Apoptosis came about in a completely new and different way, described by the scientist as "a new mechanism of cell death."
Slashes cancer growth in rodents
After these successful studies, the group moved on to test the HAMLET complex in three animal models of cancer.
First, they administered it to rats with brain tumors. HAMLET caused a significant reduction in tumor growth. After eight weeks the tumors in the HAMLET group grew to only 63 millimeters but the tumors in the control group grew more than seven times bigger-- to 456 millimeters.
In mice bred to develop colon cancer, researchers fed them HAMLET for ten days and saw tumor growth reduced by 60 percent and the mice lived longer.
Next, they gave HAMLET to baby mice for ten weeks after they finished weaning. Although the mice were engineered to develop colon cancer, HAMLET reduced the cancer’s development, also by 60 percent.
In mice with bladder cancer, researchers injected HAMLET directly into the organ, where it was shown to hold back tumor growth, significantly decreasing tumor size and delaying development compared to controls.
These were excellent results. Would it perform as well in humans?
Encouraging early findings
The very first randomized, placebo-controlled, double-blind human study, published in 2004, delivered HAMLET in the form of an ointment.
Researchers tested it on skin warts caused by the human papilloma virus—the virus that causes cervical cancers and throat cancers— in patients resistant to conventional treatment.
The results were impressive. All 20 in the active group saw lesion volume fall by 75 percent or more, and HAMLET was effective in 88 of the 92 papillomas. Of the 20 in the placebo group, just three saw a reduction in tumor volume; overall the reduction occurred in only 15 of 74 papillomas.
In 2007, the researchers enrolled nine patients who suffered from a form of bladder cancer called superficial or non-muscle invasive. It's an early form of the disease where the cancer cells are restricted to the inner lining of the bladder.
Each was injected with HAMLET directly into the bladder for five days before scheduled surgery. This stimulated a rapid shedding of mostly dead tumor cells into the urine after each daily treatment, a very encouraging result.
HAMLET becomes a drug
For the therapy to progress to clinical trials where very large quantities of HAMLET would be needed, Prof. Svanborg considered it necessary to create the protein-lipid complex synthetically. In other words, HAMLET started off as all-natural, but was now turned into a drug.
Alpha1H was born and the first clinical trial got the go-ahead.
The first phase of this trial in 40 patients with superficial bladder cancer is finished, and Prof. Syanborg announced the results last year.
The clinical trial was similar in design to the previous bladder cancer study, except that patients received six infusions of either the drug or placebo via catheter into the bladder over 22 days while they awaited surgery.
The data analysis revealed highly significant differences between the 20 patients treated with the drug and the 20 on placebo for several critical variables.
Prof. Svanborg reported that all 20 patients in the Alpha1H group saw rapid excretion of tumor cells, and even whole tumor fragments. Analysis of the cells showed they had died through apoptosis, supporting the laboratory findings. What’s more, the drug was safe, without any side effects.
Prof. Svanborg concluded, "the results inspire us to continue efforts making Alpha1H available to cancer patients.
"The vision would be to make it available worldwide to patients who are susceptible to certain cancers or who suffer from tumors that can be reached and treated with this substance."
The second phase of the trial will test different dosages of the drug for safety and efficacy. It's due to finish in 2022.
But what if you don’t want to wait for the drug? What about going to the original source, breast milk?
To drink or not to drink - that is the question
As odd as it may seem, the market for breast milk for adult consumption has been booming for many years.
Men buy it over the internet, believing claims that it can improve athletic performance or improve sexual performance. Some believe it is a magic elixir with powers to cure all sorts of diseases. Others just see it as a nutritionally rich drink that's a better option than cow’s milk.
After the media highlighted the work being done with HAMLET a few years ago, the market for breast milk took an even bigger leap forward. But before you decide to get on the breast milk bandwagon please remember that breast milk isn’t HAMLET.
Natural HAMLET can only be extracted in the lab and does not occur in this form in breast milk itself (although researchers speculate that it may be created when the milk enters a baby’s digestive system. Scientists think HAMLET scavenges virus-infected cells that need to be removed before they become mature and start to look like cancer cells. This will not occur in adults.)
Basically, there are a number of differences between a baby's digestive system and an adult's digestive system. This means that men and women will not see the same benefits from drinking human breast milk as infants, and health claims to that effect are not supported by science.
Breast milk is the perfect food for babies, not adults.
In our view, several aspects of the story raise questions and concerns. Apparently HAMLET is a heavily modified extract from natural breast milk, and it’s not clear to us (from the little we know) how the researchers hit on this modification. How did they get from a natural extract (supposedly not effective against cancer) to the drug, and is there actually little or no benefit to the natural substance?
I also hope the decision to shift research to synthetic HAMLET was not motivated by the usual drive to turn a natural remedy into a big money-making drug. But you can count me as suspicious.
Best regards,
Lee Euler,
Publisher
References:
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC41287/
- https://pubmed.ncbi.nlm.nih.gov/15026350/
- https://pubmed.ncbi.nlm.nih.gov/23348960/
- https://www.auajournals.org/doi/abs/10.1016/j.juro.2009.12.008
- https://www.nejm.org/doi/full/10.1056/nejmoa032454
- https://pubmed.ncbi.nlm.nih.gov/17514650/
- http://hamletpharma.com/hamlet-pharma-announces-results-of-first-major-clinical-trial-for-a-new-cancer-killing-molecule/
