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Hamlet Pharma is pleased to announce that the clinical development of Alpha1H therapy in bladder cancer will be accelerated. Two studies will be conducted in parallel; a dose-escalation study, which will examine the efficacy of higher Alpha1H concentrations and a combination study, combining Alpha1H with a currently used chemotherapeutic agent.
Today Hamlet Pharma has received the permission from the Czech authorities to resume its clinical trial activities, together with the team in Prague. The dose-escalation and combination therapy studies will both be conducted, simultaneously.
There is a significant unmet medical need for new therapies in early stage bladder cancer. Over the last 30 years, only three drugs have been approved for this indication by the US Food and Drug Administration and there are issues with supply of these drugs, worldwide. Hamlet Pharma is comitted to improve the treatment options for this large patient group, using Alpha1H alone or in combination with chemotherapeutic drugs.
`'Further clinical data on Alpha1H, both as stand-alone therapy and in combination, will form the basis for our phase III strategy and facilitate clinical access'' says Catharina Svanborg, CMO and chairman of the board of Hamlet Pharma Ltd.
"We are extremely happy to resume clinical activities and take Alpha1H forward in close collaboration with the clinic in Prague" says Mats Persson, CEO of Hamlet Pharma Ltd.