Hamlet Pharma announces that the company has successfully completed two toxicology studies for the drug candidate Alpha1H. Two different animal models have been used to evaluate the local tolerance in the urinary bladder to repeated instillation of Alpha1H. The results show that Alpha1H is well tolerated and causes no local toxicity.
In order to initiate clinical studies in patients with bladder cancer, Hamlet Pharma has conducted preclinical/toxicology studies in mice and rabbits in compliance with Good Laboratory Practice (GLP). The objective of the study was to evaluate the local tolerance of urinary bladder tissue to repeated instillations of Alpha1H. Animals were divided into two groups; one exposed to the Alpha1H drug candidate and the second to the vehicle (controls). Instillations were performed during four weeks with a protocol similar to the clinical study. It was concluded that repeated instillations of Alpha1H into the urinary bladder of mice were well tolerated and that the drug candidate caused no local toxicity. These results will be used for the application to initiate clinical studies in patients with bladder cancer.
The application for ethical approval of the clinical study has been submitted and is currently under evaluation.
“We are now close to having all the necessary documentation for taking Alpha1H to clinical studies” says Mats Persson, CEO Hamlet Pharma.
“These findings are in accordance with previous studies showing that Alpha1H lacks toxicity for healthy bladder tissue. A very important step for Hamlet Pharma and for the drug candidate Alpha1H. I am looking forward with confidence to the initiation of the clinical trials” says Professor Catharina Svanborg, Chairman of the board and founder of the company.
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
About Hamlet Pharma
Hamlet Pharma AB owns and develops a new technology to kill cancer cells without harming healthy tissues. The HAMLET technology is focused around the HAMLET family of tumoricidal protein-lipid complexes, formed by naturally occurring molecules from human milk and extended to include recombinant variants of the natural substance. HAMLET has validated therapeutic efficacy in clinical studies and animal models, and in many different cellular models of human cancer. Alpha1H is a peptide that includes key tumoricidal motifs within HAMLET. Together with oleic acid, Alpha1H forms a complex that target cancer tissues selectively similar to HAMLET. Alpha1H will now be developed further for Phase II clinical trials, to verify the positive proof of concept studies. Hamlet Pharma AB shares are listed at AktieTorget. HAMLET is an abbreviation for Human Alpha- lactalbumin Made LEthal to Tumor cells.
Denna information är sådan information som Hamlet Pharma AB är skyldigt att offentliggöra enligt EU:s marknadsmissbruksförordning. Informationen lämnades, genom ovanstående kontaktpersoners försorg, för offentliggörande den 21 juli 2017.