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Uppsala, Sweden, November 14, 2017. Results from a study of 142 women with newly diagnosed metastatic breast cancer will be presented by researchers from Lund University at the world’s biggest breast cancer conference in San Antonio, USA. The study demonstrates that the DiviTum® blood-based biomarker can provide more accurate prognosis than today’s standard methods.
With imaging methods used for evaluating the effect of treatment, it takes about three months to evaluate whether the given therapy is effective or not. The new study demonstrates that DiviTum® accurately can predict outcome (progression free- and overall survival) already after one month. This dramatic shortening of the evaluation window can be key when making decisions to continue or change treatment and can contribute significantly to improved patient outcome. In addition, using a blood-based biomarker reduces the need for invasive biopsies.
DiviTum® measures the activity of the enzyme thymidine kinase (TK) which reflects cell proliferation and associates strongly with tumor growth. At diagnosis in the study, low DiviTum® values correlated significantly and independently with improved progression free- and overall survival (p<0.001). During treatment, DiviTum® was significantly associated with outcome at each of four time points and onwards (Baseline, 1, 3 and 6 months). Patients in the study were treated with standard therapies, including endocrine therapy, chemotherapy and Herceptin®, meaning that the value of DiviTum® is demonstrated in a larger patient population than has previously been reported. Biovica have an ongoing trial program including more than 10 clinical studies and 1,500 patients to document the unique capabilities of the assay to become a new gold standard for early efficacy evaluation of patients with metastatic breast cancer.
"The results demonstrate that already after just 1 month of treatment, DiviTum is a highly valuable marker for clinical use regarding accurate prognosis. Throughout the course of therapy DiviTum can provide clinical information for patients with metastatic breast cancer scheduled for 1st line systemic therapy”, says Lisa Rydén, Professor, Department of Surgery, Lund University.
"The study provides key documentation for DiviTum as a tool for putative evaluation of efficacy in a peripheral blood sample and we are delighted to publish these results in collaboration with Lund University. The study results contribute towards our objective of supplying DiviTum to oncologists as a standard tool for evaluating metastatic breast cancer treatment to improve patient outcome”, says Anders Rylander, CEO Biovica.
Reference: www.sabcs.org. Link to the abstract: http://www.abstracts2view.com/sabcs/view.php?nu=SABCS17L_287
This information is information that Biovica International AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person(s) set out above, at 08.00 CET on November 14, 2017.
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.
Biovica International AB, a Swedish biotech company founded in 2009, develops and commercializes blood-based biomarker assays that improve the monitoring of modern cancer therapies and better predict patient outcome. The initial focus is breast cancer, where approximately 1600 new cases are diagnosed every day in the EU and US alone. By collaborating with world-leading cancer institutes as well as pharmaceutical companies launching next-generation therapies, Biovica actively promotes the growing drive towards personalized medicine. Improved patient survival plus lower healthcare costs are also two anticipated outcomes.
Biovica’s clinical validation plan is supported by The European Commission and has been selected to receive funding in the Horizon 2020 phase 2 program.
Biovica is listed on Nasdaq First North in Stockholm (BIOVIC B).
Thymidine kinase (TK) is an enzyme involved in nucleotide metabolism and has a fundamental role in the DNA synthesis. It can be used as a marker of cell proliferation rate and TK activity has demonstrated correlations to prognosis and utility for treatment monitoring in different malignancies.
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