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Case Study: ApoCell’s ApoStream™ CTC Isolation Technology Being Used To Explore Biomarkers as Part of Phase 3 Global Study in Metastatic Breast Cancer

ApoStreamTM circulating tumor cell (CTC) isolation technology and analytical services is being used as part of an exploratory biomarker program for a pivotal Phase 3 global clinical trial of a new topoisomerase I inhibitor drug candidate, etirinotecan pegol (NKTR-102). The Phase 3 study is being conducted in patients with metastatic breast cancer.

The ApoStreamTM technology will support the exploratory biomarker program in the Phase 3 study by providing access to patient CTC samples in order to assess various biomarkers that could be potentially important to inhibition of the topoisomerase I enzyme, which is the mechanism of action for etirinotecan pegol. Information acquired from the CTC biomarker analysis will support the analysis of exploratory data from the study.

More information on the Phase 3 study of etirinotecan pegol (NKTR-102) can be found on clinicaltrials.gov by searching for “BEACON NKTR-102”. The BEACON study is sponsored by Nektar Therapeutics.

Darren Davis, Ph.D., ApoCell CEO said, “This Phase 3 clinical trial is the type of study where ApoStream’s novel CTC recovery capability can be of great value in analyzing the various biomarkers affected by drug therapy. We believe that our technology could provide an increased yield of CTCs to enable more biomarkers per sample to be analyzed. This is important because it could allow for monitoring of the biological responses to an anticancer agent over time.”

Although a correlation has previously been established between the number of CTCs and disease progression, the promise of widespread clinical application of CTCs has not yet been realized because these cells are rare and difficult to collect using current CTC methodologies. Commercially available CTC isolation is an EpCAM-based immunomagnetic approach, which detects only CTCs that express EpCAM, and is not effective in isolating CTCs with no or low EpCAM expression, such as those involved in metastatic dissemination.

ApoStreamTM is a new technology that does not rely on EpCAM expression and instead uses a continuous field-flow assisted dielectrophoresis (DEP) to isolate and recover CTCs from the blood of cancer patients. ApoStreamTM recovers higher numbers and more types of CTCs because it isolates cancer cells based on cell morphology, the cells’ unique properties which are different in form and structure from healthy cells. Further, ApoStream recovers the cells alive, allowing for additional biological testing and molecular analysis.

The ApoStreamTM CTC isolation technology, currently being developed and commercialized exclusively by ApoCell, has promising implications in the advancement of cancer research and treatment. By potentially offering greater CTC selection and specificity over current commercial technologies, ApoStreamTM makes possible the development of a wider array of potential applications for CTCs analysis, such as diagnosis and disease stratification, treatment selection and efficacy monitoring of therapy.