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Dose-escalation study initiated

By January 22, 2021 No Comments

Press Release, Lund January 22, 2021

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 standalone 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.


For more information, please contact

Catharina Svanborg, Chairman and founder of 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. In addition, Hamlet Pharma develops BAMLET, which is a molecular complex formed by bovine α-lactalbumin and oleic acid. Data from animal models suggest that local BAMLET treatment may be effective against colon cancer.

The project is coordinated by Prof. Catharina Svanborg and CEO Mats Persson of Hamlet Pharma. This project is funded from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 954360.

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