We opened the trial on July 1, 2019. As of June 27, 2021, we have enrolled 18 dogs in the study and no dose limiting toxicities within the initial 21-day assessment period have been observed. Based on these results, we are continuing to enroll dogs at the highest dose of propranolol (1.3 mg/kg) being tested. We did observe an adverse event in one dog at approximately month 6 of the protocol that could be attributed to propranolol (2-3 episodes of fainting/collapse), which was resolved by reducing the dose of propranolol to 1.0 mg/kg. The dog continues to do well and remains in the trail.
Propranolol and doxorubicin levels in the blood from all of the dogs enrolled to date have been analyzed.
Currently six dogs enrolled in the study are alive while twelve dogs have succumbed to their disease. Two of the dogs have survived for two years or more, and six dogs have lived longer than six months.
Enrollment of dogs into the study was severely delayed by approximately six months due to the COVID19 pandemic. Enrollment was halted at all three study sites (University of Minnesota, University of Pennsylvania, Purdue University) in early to mid-March. Although enrollment resumed at all three sites in late June/early July, we were unable to enroll another dog until September 2020. The pace of enrollment has continued to increase, and we expect to enroll the final two dogs in the study by early 2022.
We also plan to complete the analysis of drug levels (propranolol and doxorubicin) in the blood samples. Due to delays related to the pandemic, we plan to request an extension of the study in order to provide a complete follow up (up to one year) for all of the dogs enrolled. The request for the extension will be based on the date for the final dog enrolled.