At the end of July 2019, Hamlet Pharma announced the successful completion of the Phase I/II bladder cancer study. We now provide more detailed information about the study outcome. 

Twenty patients were treated with Alpha1H and patients received 6 instillations during one month, followed by surgery to remove the tumor. A further visit was included to document the safety of Alpha1H. Another 20 patients received placebo. The main study outcomes are summarized below. A final study report is being prepared for publication in an international scientific journal.

SAFETY ANALYSIS

There were no side effects related to the Alpha1H treatment. We conclude that instillation of 1.7 mM of Alpha1H into the bladder can be regarded as safe.

Adverse events (AEs)

EFFICACY VARIABLES

I. Alpha1H triggers massive shedding of tumor cells into patient urine

A rapid increase in cell shedding was detected in patients, who received Alpha1H compared to placebo (P<?0.0001). The cell shedding response was seen each time the patients received Alpha1H (Visit 1-6) but not in the placebo group. A similar increase was observed for tumor fragments, which were released into the urine of patients receiving Alpha1H (P<?0.0001).

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II. Alpha1H triggers cell death in the tumor (apoptosis)

To examine how the tumor responds to Alpha1H, biopsies were obtained from the tumor at the time of surgery. Cell death in the tumor was defined by TUNEL staining, which detects apoptosis; a beneficial, non-toxic form of cell death. A highly significant increase was observed, compared to the placebo group. The results suggest that Alpha1H accelerates cell death in the tumor.

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III. Alpha1H is taken up by tumor cells

By fluorescence microscopy, we show that Alpha1H is taken up by tumor cells, providing evidence that the drug candidate alpha1H interacts with the tumor.  

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The results reveal clear differences between the Alpha1H and placebo groups, supporting the safety and therapeutic efficacy of Alpha1H. 

 “’The results boost our confidence in Alpha1H as a safe and efficient therapeutic and our efforts to accelerate drug development in bladder cancer and other cancer indications’’ says Catharina Svanborg, founder, CMO and chairman of the board of Hamlet Pharma Ltd.   

“The results are in line with the first data presented in July and allow us to take the next step in the development of Alpha1H” says Mats Persson, CEO of Hamlet Pharma Ltd.

For more information, please contact

Catharina Svanborg, Chairman of the board, Hamlet Pharma, +46 709 42 65 49

catharina.svanborg@med.lu.se

Mats Persson, CEO Hamlet Pharma, +46 705 17 67 57

mats.persson@hamletpharma.com 

Notes to Editors

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 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. 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).

About HAMLET Pharma

HAMLET Pharma, listed on Spotlight, develops drugs based on the unique tumoricidal protein-lipid complex, HAMLET, formed by two natural and harmless molecules found in breast milk. Development focuses primarily on drugs, for the treatment and prevention of cancer. HAMLET kills tumour cells and has proven safe in proof-of-concept studies in animal models. HAMLET has also shown therapeutic efficacy on skin papillomas in a placebo-controlled clinical trial and caused shedding of dead cancer cells, after injection into the bladders of patients with bladder cancer. A phase I/II clinical trial was recently concluded in patients with bladder cancer, using the synthetic peptide-based compound Alpha1H. HAMLET is a registered trademark of HAMLET Pharma.

This information is insider information that Hamlet Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication trough the agency of the contact persons set out above, on October 11, 2019.