Hamlet Pharma announces that the production of the Alpha1H peptide has been successful and that the peptide is ready for delivery. The peptide meets the quality requirements for medicinal products according to current GMP (Good Manufacturing Practice) guidelines. Alpha1H will be used for clinical trials, first on patients with bladder cancer.
As previously announced, Hamlet Pharma has established large-scale synthesis peptide production for future clinical trials together with PolyPeptide Laboratories Holding (PPL) AB. PPL is a world leader in contract manufacturing of peptides and peptide-related molecules and is certified by authorities from different countries.
Production of new drugs is often complicated and requires cooperation between experts in many different fields. Production technology has been developed since 2016 through close collaboration between PPL, experts from different countries and areas of expertise and researchers at Lund University. This broad competence is the reason why the work has now been completed and that the Company has reached the goal of producing substance for the drug candidate Alpha1H.
”Development of substance for clinical trials are often complicated, and we are therefore very proud about the rapid advances and the success with GMP production” says Professor Catharina Svanborg, Chairman of the Board.
”A very important piece of the puzzle; an important milestone for the company’’ said Mats Persson, CEO.
For more information, contact
Catharina Svanborg, Chairman and founder of 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 phase II studies on colon cancer and bladder cancer, two difficult and common cancers. HAMLET is a registered trademark of Hamlet Pharma.
This information is such information as Hamlet Pharma AB is required to disclose under the EU Market Abuse Regulation. The information was provided by the above contact persons for publication on 17 August 2017.