Unique results show DiviTum is able to evaluate the anti-tumor activity of blockbuster cancer drug.
New clinical study results presented at the San Antonio Breast Cancer Symposium, December 6-10, 2016, demonstrate that Biovica’s DiviTum biomarker assay can evaluate the efficacy of the novel breast cancer drug palbociclib (Ibrance, Pfizer).
The U.S. 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. Ma, M.D., Ph.D., associate professor of medicine, Washington University School of Medicine, St. Louis, MO.
Breast cancer is the most common form of cancer among women today, affecting approximately 362,000 individuals in EU and 233,000 in the U.S. each year. Around 1,600 new cases are diagnosed every day and 136,000 deaths occur annually (EU+U.S.).
Palbociclib was FDA-approved in February 2015. In the drug’s first year on the U.S. 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 of Biovica.
Biovica, a biotech company, 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 prediction capability and monitoring of compounds regulating cell proliferation and the cell cycle.
(Source: PR Newswire)
Filed Under: Drug Discovery
