Hamlet Pharma Starts Two Parallel Clinical Study Programs

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.

For more information, please contact

 

Catharina Svanborg, Chairperson 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. Alpha1H is the synthetic variant of HAMLET, which has enabled development of the agent for clinical trials. Alpha1H kills different types of tumour cells and has demonstrated therapeutic effects on bladder cancer in animal models. Hamlet Pharma has one ongoing Phase I/II clinical trial with Alpha1H in patients with bladder cancer, a costly form of cancer that is difficult to treat, and intends to expand its activities into other types of cancer. The first results from the ongoing clinical Phase I/II study shows no side effects of Alpha1H, indicating that the treatment is safe and well tolerated. Alpha1H also demonstrated clinical efficacy compared with patients who received placebo.

 

This information is insider information that Hamlet Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication trough the agency of the contact persons set out above, on September 25, 2020.
 

This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No. 954360.


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