Researchers at Washington University report: DiviTum® can evaluate the biologic activity of blockbuster breast cancer drug after two weeks

Uppsala, Sweden, November 23, 2017. Results of a study from Washington University, St Louis, demonstrate that the DiviTum® can evaluate the biologic activity of Pfizer’s breast cancer drug palbociclib (Ibrance®) in just two weeks are published in the latest edition of the scientific journal Breast Cancer Research and Treatment. This shortening of the response evaluation window can improve outcome and increase quality of life for breast cancer patients.

Led by Dr Cynthia Ma, the study investigated 50 women with breast cancer treated with standard endocrine therapy in combination with Ibrance® prior to surgery. DiviTum® was used to measure cell proliferation rate in blood samples collected before and after 2 weeks of Ibrance® treatment. Results demonstrate a high ability of DiviTum® to identify each patient’s anti-proliferative effect of Ibrance®. The researchers conclude that DiviTum® can have a clinically useful role as an early indicator of treatment response to CDK 4/6 inhibitors such as Ibrance®.

Our study provides the first clinical evidence of using DiviTum for measuring TK1 activity for early evaluation of the effect of palbociclib treatment in breast cancer. The results are very promising and support future studies of DiviTum to evaluate and identify patients for response to CDK 4/6 inhibitors,” says Dr Cynthia Ma, MD, PhD, Associate Professor of Medicine, Washington University School of Medicine, St Louis, US.

There are currently three approved CDK4/6 inhibitors (Ibrance® from Pfizer, Kisqali® from Novartis and Verzenio® from Lilly) with documented ability to prolong disease progression. Far from all patients benefit from therapy, and can experience severe side-effects from a treatment priced at $ 10,000 per month.

These results correlating DiviTum to palbociclib efficacy are highly promising since there is no other blood based biomarker available for evaluating CDK 4/6 inhibitor efficacy today. CDK 4/6 inhibitors are very effective but also costly and far from all patients respond. It is therefore very important to provide new biomarkers in order to enable best possible treatments for patients and cost effectiveness for payers. These results support our aim to provide DiviTum as a standard tool for evaluating treatments in metastatic breast- and other cancers. says Anders Rylander, CEO Biovica.

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For more information 
Anders Rylander, CEO
phone: +46 (0) 18 44 44 830  

Richard Hayhurst
phone: +44 (0) 7711 821 527

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 23, 2017.

About Biovica

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.

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2019-10-03T08:45:12+00:00 November 23rd, 2017 08:00|Regulatory|