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Home » Bladder and bowel » Successful new drug candidate for patients with bladder cancer – from discovery to the clinic

Professor Catharina Svanborg

Chairman, Hamlet Pharma

From scientific discovery to the clinic — a new treatment for bladder cancer has demonstrated efficacy and safety in controlled clinical trials. The active molecule triggers apoptosis in cancer tissue — a beneficial form of cell death. The tumours respond rapidly to treatment, and fragments of the tumour are released, resulting in a reduction in tumour size. 

Scientists are developing a revolutionary, new way to tackle bladder cancer using molecules originally found in human milk. As a series of clinical trials progress to test the breakthrough, hopefully, a new drug will be developed to help provide a new treatment. 

Serendipity observation 

Professor Catharina Svanborg explains how the discovery of a tumoricidal protein-lipid complex came from a classic serendipity observation. It emerged as her research group at Lund University in Sweden was studying antibacterial components in human milk and serum to find new antibiotics. During experiments in lung cancer cells and the bacteria that cause pneumonia, they found that the tumour cells died. 

They named the active component in milk — a complex between a protein and fatty acid — HAMLET (Human Alpha-Lactalbumin Made Lethal to Tumour). “The molecule kills tumour cells very broadly, and that includes cells from bladder cancer,” explains Svanborg, who is Chairman of the Board at HAMLET Pharma and Professor of Clinical Immunology at Lund University. 

It’s a non-toxic way of telling the bladder cancer to stop growing and start this shedding of tumours.

Clinical trials 

After testing in animal models and patients with bladder cancer, the scientists were surprised with the findings. “If we put HAMLET in the bladder, the tumour responds by shedding pieces and tumour cells out into the urine, and that happens with virtually everyone we have tested it on.” 

The pharmaceutical company has performed formalised clinical trials with a synthetic drug candidate called Alpha1H, which attacks tumour tissues with a high degree of selectivity. “After drug development, we are now treating bladder cancer and performed a placebo-controlled trial with excellent results and no toxicity for healthy tissue in patients.” The next step is planning for a phase III trial. 

Svanborg says there are clear benefits. “It’s easy to administer. It’s a non-toxic way of telling the bladder cancer to stop growing and start this shedding of tumours.”

The scientists are hopeful the Alpha1H treatment can reach patients more generally soon and is seeking larger partner organisations to advance this. Bladder cancer is the fifth most common cancer in the European Union (EU) and has the highest recurrence rate of all cancer indications. The high mortality of bladder cancer is mainly caused by the lack of effective therapies and the high recurrence rate (~70%). Moreover, bladder cancer places a significant burden on the health care system with high healthcare expenses. In fact, it accounts for the highest treatment cost per patient in the cancer area.  

A family of tumour killing molecules with low toxicity and great promise 

The family of active molecules includes HAMLET and the synthetic drug candidate Alpha1H, which is the one used in the bladder cancer studies. They are also working on a bowel cancer treatment which uses a candidate called BAMLET, as it uses a protein in bovine milk. The effects of BAMLET have been extensively studied including animal models with relevance for human bowel cancer. She says trials to date suggest it as “extremely potent and beneficial” against bowel cancer in animal models. 

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