DiviTum has to date been investigated in seventeen clinical studies, of which eight were within the breast cancer area. In breast cancer, over 1,000 patients have participated, where the majority have been patients with metastatic breast cancer (n=845), but also a large number of patients with early-stage (n=211) breast cancer. The clinical trials have been performed in collaboration with world-renowned oncologists and medical institutes in several countries, including US, Sweden, Italy, Belgium, Canada and China.
DiviTum measures the activity of the enzyme Thymidine kinase (TK) in serum, plasma or cell cultures. Since the degree of TK activity is associated with cell growth, TK is a suitable biomarker for measuring tumor growth.
The summary brochure presents data that shows that the measurement of TK activity has an ability to function as a prognostic tool for tumor aggressiveness and patient survival, as well as a monitoring tool for obtaining early evidence of treatment response with chemotherapy, endocrine therapy, and cyclin-dependent kinase (CDK) inhibitors in patients with metastatic breast cancer.
Specifically, the following conclusions can be drawn from the results of the 8 completed breast cancer studies:
Measurement of TK activity has the potential to fulfill the unmet need for a rapid and precise monitoring and prognostic tool for metastatic breast cancer, providing physicians and patients with an accurate assessment that is non-invasive and provides results in a shorter time frame compared with other current biomarkers and imaging techniques.
Measurement of TK activity for frequent and early monitoring of treatment response will mean patients could be potentially be switched to a more effective treatment when current therapy is failing, with the aims of prolonging survival and reducing unnecessary side effects.
Measurement of TK activity has the potential to identify patients with the most aggressive tumors who urgently require treatment.
The strong evidence to measure TK activity thus far suggests its potential as an independent prognostic and monitoring marker.
In addition to the already performed trials, Biovica has an extensive clinical trial program that aims to further provide documentation of the clinical utility for cancer patients.
The brochure can be found here: http://biovica.com/technology/publications/