When companies like Bayer are developing new drugs, animal studies are both scientifically necessary and legally required. The innovative drug products that result from animal research help to improve the lives of patients all over the world.
Bayer´s alpha-particle emitting radioactive therapeutic agent was approved in 2013 for the treatment of CRPC patients suffering from bone metastases. In order to test, whether bone metastases originating from breast cancer can be treated by this compound, researchers from Bayer and partners used rodents – mainly mice – to study the anti-tumor activity of the agent in a model of metastatic breast cancer. Each study consisted of a control group of animals which were not treated with the compound, and treatment groups, which received varying doses of the agent. In the study described here, seven mice were in each group. This number was defined by statistical methods to guarantee that the end results would be meaningful.
Once the groups were determined, isolated tumor cells were implanted in the mice to create bone metastases. After the implantation, researchers paid close attention to the mice for several weeks in order to observe the course of the disease, their tolerance of the compound, and their general well-being.
When the study ended at a predefined point, all mice used in the study were euthanized. This is legally required. Samples were taken from each animal to answer questions about the agent’s effects on the tumor and any side effects in healthy organs. Clinical tests in humans began only once the drug was proven to be acceptably safe at the effective dose.
Thrombosis is a serious and often life-threatening complication of cardiovascular disease in which blood coagulation and platelets are over-activated, forming blood clots that block circulation. Bayer's anticoagulant has been tested in the prevention and treatment of thrombotic and thromboembolic events. It is now approved in more than 130 countries for a wide range of venous and arterial thromboembolism-related indications.