HOUSTON, Sept. 19, 2018 /PRNewswire/ -- ApoCell, Inc., a leader in the capture and analysis of circulating tumor cells (CTC), announced today the publication of biomarker results from the BEACON Phase 3 clinical trial that utilized Apocell's proprietary circulating tumor cell enrichment system, ApoStream®. Clinical results were published in the journal Clinical Cancer Research, titled 'Change in Topoisomerase 1–Positive Circulating Tumor Cells Affects Overall Survival in Patients with Advanced Breast Cancer after Treatment with Etirinotecan Pegol' (July 15, 2018 24 (14) 3348-3357). This is the first publication to show changes in a therapeutic target biomarker detected in CTCs that impacts overall survival in an important subset of metastatic breast cancer (MBC) patients.
CTCs have long been known to exist in cancer patients' blood, with a clear correlation established between the number of CTCs and disease progression. However, the promise of clinical application of CTCs as a 'liquid biopsy' has not born fruit because these cells are very rare and difficult to detect and analyze using current molecular biology techniques.
ApoCell's proprietary ApoStream technology uses a low-level electrical field to capture rare significant quantities of circulating cancer cells from small quantities of blood, including rare cell types that have previously gone undetected. ApoStream has been used in over 75 clinical trials including several other Phase 3 trials to develop liquid biopsy companion diagnostics. "The publication of the BEACON trial data is an important milestone in the field of CTC biology and a great achievement for our dedicated group of scientists," said Darren Davis, Ph.D., ApoCell President and CEO. "We are very excited and committed to continuing the commercialization of the ApoStream technology to identify which patients respond to various therapies, enabling oncologists to implement personalized medicine."
The BEACON trial treated metastatic breast cancer patients with etirinotecan pegol (EP), or a treatment of the physician's choice. Blood from 656 of 852 patients (77%) was processed with ApoStream to enrich for CTCs and measurement of biomarkers of clinical response. Overall, 97% of blood samples had detectable CTCs for biomarker assessment. Therapeutic target biomarker expression was detected in 52%-90% of CTC samples; no significant associations with overall survival were observed in pre-treatment samples for either group. Patients whose CTCs had a change from high to low biomarker expression after treatment had the greatest overall survival benefit from EP.
Dr. Edith Perez and coauthors concluded that CTC biomarker expression following EP treatment may help identify patients with MBC most likely to have an overall survival benefit. "This new technology has promising implications in the advancement of cancer research and treatment. Biomarker assessment using liquid biopsies is expected to allow for improved therapeutic selection and specificity for cancer," said Perez.
Based in Houston, Texas, ApoCell, Inc. is a privately-held specialty clinical research company. Founded in 2004, the firm is a leader in biomarker detection and analysis and leverages its expertise in the areas of immune-oncology, diabetes, molecular diagnostics and drug development to measure biomarker signatures in clinical trial subjects. The company's proprietary methods provide early proof of mechanism of action and monitor the effectiveness of various types of drugs by measuring biomarker expression patterns in biopsies, blood and rare cell types including circulating tumor cells (CTCs). The company's facilities are CLIA-certified and compliant with applicable FDA regulations. Since inception, the company has participated in over 275 Phase I, II, and III clinical cancer drug trials for more than 125 sponsor clients worldwide. For more information visit www.apocell.com.