Newsletter - Manufacturing of Alpha1H drug product and Placebo has been successfully completed and are ready for clinical use
Hamlet Pharma is happy to announce that the drug product Alpha1H and the corresponding Placebo have been successfully manufactured by the Contract Manufacturing Organization (CMO) Recipharm to be used in the clinical trial. A certificate of analysis has been issued and the manufactured drug product batch is fully active against tumor cells.
Hamlet Pharma has selected Recipharm to develop and manufacture the Alpha1H drug product based on their excellent reputation in the Life Science community and their global representation, which may be beneficial for future development and scale up of the Alpha1H drug product.
Since September 2017, after completion of the manufacture of Alpha1H peptide by PolyPeptide Laboratories, as reported in press release 17/08/2017, a massive effort has been spent to finalize the clinical drug product formulation by verification of the manufacturing process, development of analytical methods and assurance of the stability of the product. The Alpha1H drug product and the Placebo are labelled, packed and controlled and now available for clinical use.
“We have also verified that the final drug product kills tumor cells with high efficiency. This gives us confidence that we are ready to start the clinical testing” says Professor Catharina Svanborg, Chairman of the Board.
For more information, please contact
Catharina Svanborg, Chairman of the board, Hamlet Pharma, +46-709 42 65 49
Mats Persson, CEO Hamlet Pharma, +46 705 17 67 57
Hamlet Pharma company listed on AktieTorget, is a company engaged in drug development based on a tumoricidal protein-lipid complex, HAMLET, formed by two natural and harmless molecules found in breast milk. The development aims to develop drugs that primarily will be used for the treatment and prevention of cancer. HAMLET effectively kills tumor cells but have also proven to be safe in the proof-of-concept studies done on humans. The substance has demonstrated therapeutic effect on skin papillomas in a placebo-controlled clinical trial and causes shedding of dead cancer cells by injection into the bladder in patients with bladder cancer. Hamlet Pharma intends to initiate a phase II study with Alpha1H in patients with bladder cancer, a difficult and costly cancer form. HAMLET is a registered trademark of Hamlet Pharma.