Successful review of HAMLET Pharma by the EU Horizon 2020 program
Hamlet Pharma has recently delivered its 18-month report to the European Union’s Horizon 2020 program. In their response, the EU states that the project has “fully achieved its objectives and milestones for the period” and “remains in line with the objectives”.
The report summarizes the results in four parts.
- The successful conclusion of the Phase I/II study. The report states that “the results demonstrated good safety and efficacy, which is very encouraging and supports the continued development of Alpha1H towards a Phase III trial”.
- Transfer of the drug manufacturing methodology to a larger commercial facility. This challenging process has been achieved and the new product has been tested and found to be fully active in cancer cells in the laboratory.
- Initiation of contact with the FDA/EMA. Based on a positive gap analysis by Target Health of the existing data, interactions have been initiated in order to start to plan the presentation of the Phase III study design to the US FDA.
- Marketing and risk analysis. A marketing and risk analysis plan for the bladder cancer project has been presented. Options are to co-develop Alpha1H for this indication together with Large Pharma partners through for example a licensing deal, or with investor funding.
We greatly appreciate the continued support from the Horizon 2020 program (2.1 million Euro) which accelerates our development.
For more information, please contact
Catharina Svanborg, Chairperson of the board, 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 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.
This project is funded from the European Union’s Horizon 2020 research and innovation program under grant agreement No 954360.