Uppsala, Sweden, April 3 2017. The latest data of the DiviTum® assay as an efficacy marker of CDK4/6 inhibition was presented in an oral session by Dr. Geoffrey Shapiro, Dana-Farber Cancer Institute, at the 2017 American Association for Cancer Research (AACR) Annual Meeting.
The results, presented as part of an ongoing clinical trial (NCT02022982) at the Dana-Farber Cancer Institute, demonstrate that the DiviTum® assay for determining Thymidine Kinase Activity (TKA) can be a practical, non-invasive tool for monitoring the efficacy of CDK4/6 inhibitors. There is a great need for a method that provides information about treatment efficacy for these novel therapies in order to optimize patient outcome and health economy. The data presented strengthen the fact that DiviTum® has the potential to become such a method.
The clinical data include DiviTum® analysis of the first 20 patients with solid tumors. DiviTum® was used to measure levels of TKA in blood samples collected before and during treatment with palbociclib (Ibrance®, Pfizer) in combination with a MEK-inhibitor. Changes in TKA measured by DiviTum® significantly reflected mode of action response to palbociclib.
During the AACR Meeting Biovica presented an abstract on DiviTum® analysis of TKA and TK release in response to palbociclib in cellular extracts, tissue culture media and mice models together with the Dana-Farber Cancer Institute and the Karolinska Institute. The abstract supports DiviTum® as a practical, non-invasive tool for monitoring the efficacy of CDK4/6 inhibitors in both preclinical models and patients.
“The results provide guidance for using DiviTum as a test to gain early information on the response to palbociclib. We look forward to including more patients in the study and providing more evidence for DiviTum as a noninvasive assay for patients treated with CDK4/6 inhibitors”, says Dr Geoffrey Shapiro, MD, PhD, Director, Early Drug Development Center at the Dana-Farber Cancer Institute.
“These results, adding to the results presented at SABCS in December 2016, furthers strengthens the evidence that DiviTum® can indicate response to CDK4/6 treatments. Now there is evidence from cell lines, animal models, patients with breast cancer and other solid tumors including lung cancer. Going forward, we’ll continue building solid evidence of the value DiviTum® can bring to patients and health care providers.”, says Anders Rylander, CEO Biovica.
Anders Rylander, CEO Biovica.
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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.