ONGOING CLINICAL TRIALS

Biovica is currently engaged in several clinical studies with leading European and US researchers and institutions to generate a comprehensive clinical validation portfolio for DiviTum™ in a number of different tumor types and oncology applications. The major scope of the clinical research pipeline is to generate high impact, high quality clinical data on the performance of DiviTum™ in the context of key oncology applications.

The  PYTHIA study – IBCSG and BIG

PYTHIA will follow women with advanced breast cancer being treated with anti-hormonal therapy in combination with the CDK-inhibitor Ibrance. DiviTum™ will be used to analyse blood taken from patients before and during therapy. The main purposes by including DiviTum™ are to explore whether DiviTum™ can assist physicians in predicting which patient will respond to this therapy and in monitoring drug efficacy during treatment.

“We want to explore the potential of DiviTum™ to identify those breast cancer patients with a higher likelihood of response to palbociclib.We will also use DiviTum™ to monitor patients while on treatment with palbociclib with the aim of testing whether this could be proposed as a new biomarker of treatment of efficacy”,
Dr Luca Malorni, MD, PhD, Principal Investigator of the PYTHIA study, Hospital of Prato, Italy

Dana Farber Cancer Institute

The Dana-Farber Cancer Institute has included DiviTum™ in a clinical trial to analyze serum from patients with late stage KRAS-mutation positive solid tumors. The study will evaluate new, specific, cell-cycle-dependent drugs (CDK inhibitors) in combination with MEK-inhibitors. The aim is to determine whether DiviTum™ can predict response and monitor efficacy before and during treatment with the new drugs.

“We appreciate this opportunity to test DiviTum™ in a clinical study and assess its potential as a serum biomarker. We look forward to the results.”
Dr Geoffrey Shapiro, MD, PhD, Director, Early Drug Development Center, Principal Investigator in the study, Dana-Farber Cancer Institute

Karolinska Institute

DiviTum™ is included in the PREDIX LumA, a state-of-the art study at the Karolinska Institute and Radiumhemmet, Stockholm. The study will enroll 200 women with hormone-dependent breast cancer who will be treated with endocrine therapy in combination with Ibrance, a CDK inhibitor. DiviTum™ will be used to analyze blood taken from patients before and during therapy. The main purposes of the study are to identify which women are most likely to respond to treatment and to evaluate therapeutic efficacy during treatment.

“We have chosen to include DiviTum™ in the study to see if we can use it as a non-invasive marker of efficacy for this new class of drugs called CDK4/6-inhibitors. This is a very promising group of new drugs, but we lack a reliable marker of tumor proliferation to evaluate and predict efficacy. There is a reasonable potential and scientific rationale that DiviTum™ may correlate with the efficacy of these new drugs”
- Thomas Hatschek, lead investigator for the study and Associate Professor, Karolinska Institute