On January 17, 2022 Hamlet Pharma reported the successful completion of a Phase I/II study using a 1.7 mM dose of Alpha1H (Press release, HAMLET Pharma, JAN 17, 2022, View Source;utm_medium=rss&utm_campaign=successful-completion-of-the-dose-escalation-study-in-patients-with-bladder-cancer [SID1234605508]). We are now excited to report the successful completion of the dose escalation extension of the Phase I/II trial, demonstrating more potent effects of Alpha1H for key study parameters. The results are very encouraging for our continued work towards Phase III trials.

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The tumors were more strongly affected by Alpha1H at higher doses than in patients treated with the lower dose, as shown by more extensive shedding of tumor cells and tumor fragments into patient urine. As shown earlier, significant cell shedding or apoptosis did not occur in the placebo group, confirming the treatment effect.

Tissue analysis detected tumor fragmentation and shedding of tumor fragments from the remaining tumor, with large affected areas. In addition to the changes in the tumors, a pronounced apoptotic response was detected in cells and tumor fragments shed by the treated patients, confirming that Alpha1H accelerates cell death in the tumor. Apoptosis is a beneficial, non-toxic form of cell death, and therapies inducing apoptosis in growing tumors are highly desirable to limit the side effects of cancer therapy.

Furthermore, the tumor fragments in urine were shown to contain large amounts of Alpha1H, confirming the efficiency with which the higher doses of Alpha1H reach tumor tissue. The results suggest that the uptake of Alpha1H by tumor cells is a direct trigger of apoptosis, tumor fragmentation and release of the affected tumor fragments into the urine.

Dose-finding studies are essential to understand the potential of new drugs and define the optimal therapeutic window. The dose-dependent increase in therapeutic efficacy further emphasizes the potential of Alpha1-oleate for use as a drug in bladder cancer.

"’The dose-finding studies are essential for the continued development of Alpha1H for Phase III trials and for the dialogue with authorities like the FDA," says Catharina Svanborg, founder and chairman of the board of Hamlet Pharma Ltd.

"We are delighted to have reached this point in our development towards Phase III trials" says Mats Persson, CEO of Hamlet Pharma Ltd.