In spring 2018, a safety study in dogs was started under the lead of Associate Professor David Woldbye, Department of Neuroscience, University of Copenhagen. The animal phase of the study was finalized in August 2018, whereas the laboratory testing and imaging and the pathology examinations were performed during fall and winter. The final report has now been released.
The study tested the health reactions and potential adverse effects of the intracranial injection of the gene therapy vector in experimental beagle dogs. All the dogs completed the study successfully without observable adverse reactions in the daily observation scheme, and the final pathology report and neurological examinations of the dogs showed no related changes. The vector function in dog brain tissue and its transient presence in blood were tested satisfactorily.
“The final study report is now received and while we have already informed about the individual safety results as they emerged, the overall report is a confirmation of the good outcome of this study. The results clearly demonstrate that the gene therapy treatment is well-tolerated and appears to be a mild procedure for the dogs. I find this very promising for the further development of the gene therapy product for dogs, but also an encouraging signal for a future use for human patients” says Anja Holm, CEO of Panion.