Dose-escalation study initiated
Hamlet Pharma is proud to announce the inclusion of patients in the dose-escalation study of bladder cancer in Prague. The study will examine the efficacy and safety of our drug candidate Alpha1H at higher doses than used in the previously communicated clinical study.
In preparation for Phase III trials, it is essential to optimize the treatment dose for patient safety and efficacy. As previously communicated, Alpha1H has shown clear efficacy as a stand-alone therapeutic agent in bladder cancer patients and is under continuous active development. Hamlet Pharma now initiates the dose-escalation program involving five times and ten times higher doses than those used in the previous part of the trial. The clinic in Prague has recruited the first patients into the study and several more patients have been identified as potential candidates for the dose-escalation study as well as for the combination part, which will be conducted in parallel. The team working with the clinical study is experienced and highly motivated to continue the investigations of Alpha1H, in order to define its potential new treatment of bladder cancer.
The Food and Drug Administration has declared bladder cancer a great unmet medical need, as very few new treatments are available for this patient group. Hamlet Pharma is committed to improving the treatment options, using Alpha1H alone and/or in combination with chemotherapeutic drugs. We feel confident that the recruitment of patients now will proceed, despite the COVID-19 pandemic. The staff is taking all necessary precautions for a safe recruitment and treatment of patients during the study.
‘’Continuing the clinical program and reaching patients in need of new therapies is our highest priority’’, says Catharina Svanborg, Chairman and Founder of Hamlet Pharma.
‘’Extensive clinical trial experience in the Hamlet Pharma team explains the efficient progression of the clinical trial program’’, says Mats Persson, CEO of Hamlet Pharma.