UPPSALA, Sweden, December 12, 2016 /PRNewswire/ --
New clinical study results presented at the San Antonio Breast Cancer Symposium, the world's leading breast cancer conference, 6-10 December 2016, demonstrate that Biovica's DiviTum™ biomarker assay can evaluate the efficacy of the novel breast cancer drug palbociclib (Ibrance®, Pfizer).
The US study, performed by Dr Cynthia Ma, St Louis, investigated 50 women with clinical stage II or III estrogen receptor positive, HER2 negative breast cancer, treated with anastrozole in combination with palbociclib prior to surgery. DiviTum™ was used to measure levels of thymidine kinase (TK) activity, an enzyme closely linked to cell proliferation rate, in blood samples collected before and after treatment. Results demonstrate a highly significant correlation between the anti-proliferative effect of palbociclib and the reduction in TK levels measured by DiviTum™ post 2 weeks of adding palbociclib and at the time of surgery. The assay may thus serve as an early indicator of treatment response by CDK 4/6 inhibitors like palbociclib.
"Our study provides the first clinical evidence of a method, DiviTum™, for palbociclib treatment effect 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.
Breast cancer is the most common form of cancer among women today, affecting approximately 362,000 individuals in EU and 233,000 in the US each year. Around 1,600 new cases are diagnosed every day and 136,000 deaths occur annually (EU+US).
Palbociclib was FDA-approved in February 2015. In the drug's first year on the US market, more than 20,000 women were prescribed the medicine, whose sales are estimated to exceed $ 2 billion in 2016. In November 2016 palbociclib was approved in the EU.
"These first results correlating DiviTum™ to palbociclib efficacy are highly promising since there are no other biomarkers available for CDK 4/6 inhibitors today. We aim to provide DiviTum™ as a tool for clinicians to optimize the survival and quality-of-life benefits gained by patients treated with this new class of drugs," says Anders Rylander, CEO Biovica.
Biovica is a biotech company focused on providing improved diagnostics, predictive data and monitoring of cancer patients under treatment. Biovica has developed DiviTum™, a highly sensitive assay for measuring cell proliferation. Since one of the most fundamental characteristics of cancer is uncontrolled and increased cell growth, DiviTum™ enables valuable prediction capability and monitoring of compounds regulating cell proliferation and the cell cycle. Biovica is ISO 13485 certified for Quality Management Systems and DiviTum™ is CE labeled and MPA registered.