Hamlet: HAMLET Pharma releases further data from clinical study
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)
No. of AEs Active (n=20) Placebo (n=20) Total (n=40)
Drug-related AEs 0 - 0
Serious AES 0 1 1
AE resulting in discontinuation 0 0 0
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.