Hamlet Pharma has been granted permission for a 2-year follow up study
The phase I/II study in patients with bladder cancer addresses the safety of our drug candidate Alpha1H and measures biomarkers of efficacy. The protocol is designed for rapid evaluation, as the patients are under treatment for only one month each. So far, even though the study protocol is blinded and placebo-controlled, we can conclude that the safety profile is excellent.
The short-term effects of Alpha1H in this patient group will be evaluated, as soon as all patients have completed the one-month study. In addition, we intend to follow the patients for a longer period of time, to investigate long-term positive effects of Alpha1H treatment. An application to the Czech authorities was therefore filed last year.
Hamlet Pharma is now happy to announce that we have been granted permission to follow the treated patients and the placebo group for two years, after completion of the initial study.
''This follow up is essential to understand if Alpha1H has long term positive effects on bladder cancer in this patients group’’says Professor Catharina Svanborg, Chairman of the Board.
''A very important piece of the clinical trial puzzle; an important milestone for the company’’ says Mats Persson, CEO.
For more information, please contact
Catharina Svanborg, Chairman of the board, Hamlet Pharma, +46 709 42 65 49
catharina.svanborg@med.lu.se
Mats Persson, CEO Hamlet Pharma, +46 705 17 67 57
mats.persson@hamletpharma.com
About HAMLET Pharma
HAMLET Pharma, listed on Spotlight, develops drugs based on the unique tumoricidal protein-lipid complex, HAMLET, formed by two natural and harmless molecules found in breast milk. Development focuses primarily 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 on skin papillomas in a placebo-controlled clinical trial and caused shedding of dead cancer cells, after injection into the bladders of patients with bladder cancer. A phase I/II clinical trial is currently under way in patients with bladder cancer, using the synthetic peptide-based compound Alpha1H. HAMLET is a registered trademark of HAMLET Pharma.