The ongoing phase I/II study with 40 patients is due to complete in May/June 2019. The last study patient is expected to undergo scheduled surgery in the third week of May and the analysis of study outcomes will be started one month later, when all patients have completed their mandatory follow-up visits.
The study has been executed with efficient patient enrollment, clinical precision and expert evaluation of study parameters. This rapid completion of the study reflects the passion, commitment and truly remarkable work of the organization as well as the competence of then many experts that form the Hamlet Pharma team.
The study will address the safety of Alpha1H and will measure biomarkers of therapeutic efficacy in bladder cancer. While the study protocol is blinded and placebo-controlled, we can conclude that the safety profile looks excellent. The discovery of HAMLET defines a new class of cancer drugs with greater precision to kill tumor cells than most current drugs.
“We are proud to complete this study and look forward to further evaluating the efficacy of Alpha1H in this important trial” says Professor Catharina Svanborg, Chairman of the Board.
“We are so impressed by the study site in the Czech Republic and are now with excitement looking forward to evaluating the results” says Helena Lomberg, Board member.
For more information, please contact
Catharina Svanborg, Chairman and founder of Hamlet Pharma, +46-709 42 65 49
Mats Persson, CEO Hamlet Pharma, +46 705 17 67 57
About Hamlet Pharma
Hamlet Pharma, listed on Spotlight, develops drugs based on the unique tumoricidal proteinlipid complex, HAMLET, formed by two natural and harmless molecules found in breast milk. Development focuses on drugs, for the treatment and prevention of cancer. HAMLET kills tumour cells and has proven safe in proof-of-concept studies in animal models. HAMLET has also shown therapeutic efficacy against human skin papillomas in a placebo-controlled clinical trial and to trigger shedding of dead cancer cells in patients with bladder cancer. The phase I/II clinical trial test Alpha1H – a synthetic, peptide-based 2nd generation drug candidate. HAMLET is a registered trademark of Hamlet Pharma.