In their response, the European Commission stated: “Hamlet Pharma’s Project has delivered exceptional results with significant immediate or potential impact.” The Commission further concluded: “The Project has fully achieved its objectives and milestones for the period. Encouraging clinical data were produced. The treatment was also shown to be safe and no drug-related side effects were observed.’’
The EU reviewers further mention that: “Hamlet Pharma AB is developing a revolutionary cancer treatment on a peptide-based platform for targeting and killing tumor cells with high precision.”
Their evaluation further states that: ‘’Hamlet Pharma’s proprietary drug complex is derived from the human breast milk protein, alpha-lactalbumin, and represents a therapeutic solution with high tumor-killing capacity, high target specificity with no demonstrated toxicity killing more than 40 different types of tumor cells. The EU-funded project will advance this drug complex, in combination with the synthetic drug candidate Alpha1H, into clinical development as an early-stage treatment for bladder cancer, which has the highest recurrence rate among all cancer types.
In the final reporting period of this project, the Phase I/II study of Alpha1H in bladder cancer patients was completed and the final study report was submitted. Encouraging clinical data were produced. The treatment was also shown to be safe and no drug-related side effects were observed. The results were published in Nature Communication 2021. Importantly, the company has now engaged in regulatory dialogue with FDA and EMA. This is a critical step to ensuring the completeness of the data generated so far and to secure input in the study design for the Phase III study.
The company has also undertaken a project valuation and Health Technology assessment and the results are encouraging. However, these data will need to be validated at a later stage with the Health Technology Assessment bodies in Europe and also in the US.”
‘’To be labeled exceptional by the European Commission is a great honor and an acknowledgement of the quality of the drug development process in Hamlet Pharma’’, says Catharina Svanborg, Founder and Chairman of the Board.
For more information, contact
Catharina Svanborg, Chairman and founder of Hamlet Pharma, +46 709 42 65 49
Martin Erixon, CEO of Hamlet Pharma, +46-733 00 43 77
martin.erixon@hamletpharma.com
Följande bilagor finns för nedladdning:
EU_Horizon_Hamlet Pharma_PRV_v2
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