On July 22, 2019 HAMLET Pharma is reported the successful outcome of the Phase I/II trial, aimed at studying the safety and efficacy of Alpha1H in patients with bladder cancer (Press release, HAMLET Pharma, JUL 22, 2019, View Source [SID1234537656]). 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.
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Alpha1H triggered significant shedding of cells in all tumor patients, who received the treatment (p< 0.0001).In addition, Alpha1H triggered the excretion of whole tumor fragments into the urine (p<0.0001), illustrating the potent effect compared to the placebo group.
"This is a bench-to-bedside moment and we are grateful to all, who have made this possible. The results inspire us to continue the efforts making Alpha1H available to cancer patients," says Catharina Svanborg, founder, CMO and chairman of the board of Hamlet Pharma Ltd.
"This is a very important milestone for the company. We need more evidence but hopefully this could be the gentle chemotherapy of the future," says Mats Persson, CEO of Hamlet Pharma Ltd.
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 6 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 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.
Notes to Editors
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).