How breast milk dissolves cancers in trials

Scientists have shown in clinical trials that breast milk could provide the elusive cure for cancers.

The trial results published Monday in the journal BioSpace showed how a chemical found only in breast milk helps break up tumours into fragments in the body, allowing cancer patients to pass them through their urine.

The milk sugar alpha1H, which is essential to a baby’s development, has been shown to destroy tumours without harming healthy tissue. One study found 20 bladder cancer sufferers excreted tumour fragments in their urine after just six infusions of alpha1H.

Further research suggests patients start to pass malignant tissue within two hours of treatment. When alpha1H binds to the fat oleic acid, they form a “tumoricidal” complex that triggers cancerous cells into “suicide”.

Researchers from the Czech Republic hope this could be a “gentler” form of chemo, with conventional treatments “poisoning” cells and causing nasty side effects.

The drug manufacturer Hamlet Pharma Limited plans to test if the chemical shrinks bladder tumours and improves patient survival.

The research has been carried out by Motol University Hospital in Prague and was overseen by Professor Catharina Svanborg, who founded Hamlet Pharma Limited.

The work has been published in leading international journals like The New England Journal of Medicine, GUT commented in Nature Reviews Gastroenterology and PNAS (Proceedings of the National Academy of Science, USA).

Meanwhile, a first-in-human study of alpha1H, in patients with non-muscle invasive bladder cancer was published last year in ClinicalTrials.gov by Hamlet Pharma AB.

A research group in Lund led by Professor Catharina Svanborg discovered in 1995 that a component of human breast milk kills tumour cells without harming mature, healthy cells. Further experiments and studies have shown that the effect is due to the most common protein in human milk, alpha-lactalbumin, but in a new shape, bound to oleic acid. This new biological complex was called Human Alpha-lactalbumin Made Lethal to tumour cells, abbreviated HAMLET, and is a tumoricidal protein-lipid complex, formed by two GRAS (generally regarded as safe) molecules present in human milk. The novel therapeutic entity HAMLET is formed specifically when the human milk protein alpha-lactalbumin undergoes a conformational change and binds to oleic acid.

HAMLET Pharma announced the successful outcome of the Phase I/II trial, aimed at studying the safety and efficacy of Alpha1H in patients with bladder cancer. The first data analysis has revealed highly significant differences between the Alpha1H treated patients and the placebo group, for several crucial efficacy variables. Treatment was also shown to be safe, as no drug-related side effects were observed.

Alpha1H triggered significant shedding of cells in all tumor patients, who received the treatment. In addition, Alpha1H triggered the excretion of whole tumor fragments into the urine, illustrating the potent effect compared to the placebo group.

Alpha1H triggered cell death in the tumor, as shown by cytolysis and apoptosis, a beneficial form of cell death. These findings support the key mechanisms of action of Alpha1H discovered in the laboratory and the successful translation from the laboratory to the clinic.

Carefully selected safety variables were recorded according to safety guidelines. The effects of Alpha1H occurred without drug-related side effects in the patients, consistent with the lack of toxicity observed in animal models of bladder cancer.

The clinical trial of 40 patients (20 placebo and 20 with treatment who received six infusions over 22 days) has been a technical success, due to the competence and commitment of the different study teams involved. A team of experts at the Motol University Hospital in Prague, Czech Republic handled patient enrolment, clinical care, pathology assessments, and treatment. The study was monitored by a highly renowned, clinical trial CRO in Prague. Scientific coordination was from Lund University, where research sample analysis was handled and molecular information obtained. Additional study variables will be communicated as soon as data is available.

HAMLET Pharma plans to conduct further studies in bladder cancer and several other cancer indications, such as colon cancer and brain tumors; all hard to cure with current therapies. HAMLET Pharma has 35 patents for the manufacturing and use of HAMLET as well as the second-generation Alpha1H derivative of the HAMLET molecule. HAMLET has been found to kill more than forty types of cancer cells to date in laboratories.

Meanwhile, according to a global health expert, only three African countries are expected to meet the global target for exclusive breastfeeding, “an unparalleled source of nutrition for newborns and infants, no matter where they are born.”

The three nations, Guinea-Bissau, Rwanda, and São Tomé and Príncipe, are singled out in a new study from the Institute for Health Metrics and Evaluation (IHME) at the University of Washington’s School of Medicine, United States (U.S.).

The study, published Monday in Nature Medicine in advance of World Breastfeeding Week August 1-7, finds areas of persistent low prevalence in countries that have made progress overall. Detailed maps accompanying the analysis reveal vulnerable populations, especially those living in rural areas and in extreme poverty.

However, researchers note that that several nations, including Burundi, Rwanda, and parts of Ethiopia, Uganda, and Zambia were among the highest rates of exclusive breastfeeding levels in 2000 and 2017. Sudan had some of the “highest and most consistent rates of increase” toward the exclusive breastfeeding goal of the World Health Organization (WHO) – prevalence by 2025 of at least 50 per cent nationwide.

The Global Burden of Disease, the annual comprehensive health study, attributed 169,000 child deaths to lack of breastfeeding in 2017, more than half of them in sub-Saharan Africa. Moreover, according to the WHO, increasing breastfeeding to near-universal levels could save more than 800,000 lives every year, the majority being children under six months.

The paper examines breastfeeding prevalence down to the level of individual districts and municipalities and compares progress among 49 African nations. The paper is accompanied by an interactive visualization tool that allows users to compare the prevalence of exclusive breastfeeding within and across countries, look at the rate of change over time, and see the probability of meeting WHO’s a goal by 2025.

The value of exclusive breastfeeding of children cannot be over-emphasized.

Dr. Ellen Piwoz of the Bill & Melinda Gates Foundation said: “Breastfeeding is an unparalleled source of nutrition for newborns and infants, no matter where they are born. If we are serious about ensuring that every infant is offered a healthy start in life, we need to know who isn’t being reached with the support they need to breastfeed.

“By illustrating where exclusive breastfeeding rates are falling behind, these maps are a powerful tool to help policymakers and practitioners examine and act on disparities within their countries.”

In 2017, at least a two-fold difference in exclusive breastfeeding prevalence existed across districts in 53% of countries, a three-fold difference in 14% of countries, and a more than six-fold difference in Niger and Nigeria.

Exclusive breastfeeding refers to mothers using only breast milk to feed their children for the first six months, with medications, oral rehydration salts, and vitamins as needed. The practice provides essential nutrients and can prevent infection and disease, particularly in areas without access to clean water.

The study’s detailed maps reveal vulnerable populations left behind. Senegal, Angola, Ethiopia, and Tanzania had areas with a less than five per cent probability of meeting the WHO target and, simultaneously, communities with a greater than 95 per cent probability of meeting the target.

Lead author, Research Scientist at IHME, Dr. Natalia Bhattacharjee, said: “Our maps allow us to see patterns and trends that are not visible at the national level. They serve as an invaluable resource to ministries of health and others making decisions to advance child well-being.”

The WHO and other organisations celebrate World Breastfeeding Week to encourage breastfeeding and improve the health of babies globally. They advocate for “family-friendly policies to enable breastfeeding and help parents nurture and bond with their children in early life, when it matters most,” according to the WHO website. This includes enacting paid maternity and paternity leave.

The paper is part of the Local Burden of Disease project (LBD) at IHME, led by Dr. Simon I. Hay, Director of Geospatial Science at IHME and Professor of Health Metrics Sciences at the University of Washington’s School of Medicine. The Gates Foundation-funded it.

“Our collaboration with the Gates Foundation, as well as other researchers, academics, and clinicians throughout the world, enables us to develop the best tools possible for reaching populations where health care support can make the biggest difference,” said Hay.

This study is the latest in a series of IHME papers as part of the institute’s LBD project, which produces estimates of health outcomes and related measures covering entire continents at a fine resolution. Project leaders are seeking additional collaborators, including academics, researchers, and others, to contribute data and to evaluate draft papers.