Manufacturing of Alpha1H for clinical trials is secured
Hamlet Pharma has signed a contract with Rechon Life Science AB for the manufacture of clinical batches of Alpha1H. The batches will be used for continued phase II and future phase III clinical trials in patients with bladder cancer.
Hamlet Pharma is committed to the development of the drug candidate Alpha1H for bladder cancer therapy. Larger amounts of drug will be needed for the continued clinical trial program, which involves larger study populations.
In order for us to secure drug for the clinical study program, we have signed a contract with Rechon Life Science AB. Rechon is a well recognized contract manufacturing organization based in Malmö and offer a complete pharmaceutical service including preparation, packaging and distribution of Clinical Trial Supplies for clinical studies phases I-IV.
Production is carried out in accordance with GMP and Rechon is a manufacturer approved for pharmaceutical supply worldwide (including the US). The production will be preceeded by technology transfer from our laboratory as well as from previous suppliers.
”Supply of GMP approved Alpha1H is essential for the next phase of clinical development” says Catharina Svanborg, CMO and chairman of the board of Hamlet Pharma Ltd.
‘’We are very pleased to have entered into a partnership with Rechon Life Science AB. Large-scale manufacturing is one of our highest priorities”, 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
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.
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.