Biovica has a comprehensive study program with DiviTum® to demonstrate the clinical value for cancer patients. Biovica has published a summary brochure in order to share knowledge about results achieved so far with DiviTum® to researchers, oncologists and other stakeholders. The summary describes all clinical studies presented where DiviTum® is used to evaluate response to breast cancer treatment.
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/
“After completing and publishing 17 clinical trials in total out of which 8 are within breast-cancer, we’re seeing a recurring pattern of the value DiviTum® can bring to cancer patients. Hence, it is important for us to summarize this into a document in order to provide the big picture. The results further strengthen our belief that we can achieve our vision – Best treatment from day one!”, says Anders Rylander, CEO Biovica.
Anders Rylander, CEO Biovica.
Phone: +46 (0)18 444 48 35,
Biovica develops and commercializes blood-based biomarker assays that improve monitoring of modern cancer therapies and predict patient outcome. The company’s DiviTum® assay, a test for accurately measuring cell proliferation, has successfully demonstrated its capabilities to early evaluate therapy effectiveness in several clinical trials. Biovica aims to make best-possible-treatment from day one a reality.
Biovica collaborates with world-leading cancer institutes as well as pharmaceutical companies launching next-generation therapies. The company is ISO 13485 certified for Quality Management Systems. DiviTum® is CE-labeled and MPA-registered. Appointed Certified Adviser to the company is FNCA Sweden AB, firstname.lastname@example.org, +46 8 528 00 399.
Read more: www.biovica.com