ApoCell, Inc. announced that the first prototypes of its ApoStreamT circulating tumor cell (CTC) isolation system have been delivered to select investigator sites including SAIC-Frederick Inc. (SAIC-F) in support of the National Cancer Institute (NCI). The delivery is part of a $2.9 million subcontract awarded to ApoCell in Q1-2011 by SAIC-F to develop a device capable of isolating live cancer cells from small volumes of blood. While ApoStreamT has been used in ApoCell's laboratories since 2010; this first external placement of the technology is a significant milestone in the company's plan to commercially offer the device as a vital tool in the development of targeted therapies for the prevention and treatment of cancer.
"The NCI research environment has provided an ideal first external placement for ApoStreamT and the performance of the device to date has been consistent with our own findings," said Darren Davis, ApoCell president and CEO, adding that results were presented at the Molecular Medicine Triconference on February 15, 2013. ApoCell has shipped four ApoStreamT prototypes to NCI and will deliver a total of 12 by year end, Davis said.
ApoCell has incorporated ApoStreamT into a number of ongoing early and late stage clinical trials as part of the company's service offering.
The recent external placement of ApoStreamT prototypes enables the company to begin its beta-testing program for third party validation of the technology. ApoCell is now looking to place ApoStreamT prototypes at additional investigator sites around the world as part of the beta testing phase. The company plans to commercially launch the technology for research-use-only in 2014.
CTCs have long been known to exist in cancer patients' blood and clinical correlations have been established between CTC counts and disease progression. These circulating cells represent an attractive target for clinicians seeking to assess a patient's disease state; however the clinical promise of using CTCs to select appropriate treatments and monitor effectiveness has yet to be fully realized. One reason is that CTCs are extremely rare and difficult to isolate using the commercially available technologies, many of which rely on antibodies that attach to specific cancer cell antigens such as EpCAM.
ApoStreamT is antibody independent and utilizes a process known as dielectrophoresis (DEP) field-flow assist. The technology employs a non-uniform electrical field at specific frequencies to separate viable cancer cells from normal blood cells by relying on a cancer cell's unique form and structure rather than surface antigen expression. ApoStreamT has been shown to detect significant quantities of intact CTCs from a wide range of cancer types, enabling more robust downstream analysis for greater understanding of each patient's disease.
After the commercial launch of the research-use-only instrument, Davis said ApoCell plans to continue developing ApoStreamT technology for a clinical point-of-care device that would provide oncologists with more effective monitoring of targeted therapies for various cancer types.
The company's goal is to launch a clinical instrument in 2016.
"We believe ApoStream can play a significant role in the evolution of personalized cancer treatment," Davis said.
Based in Houston, ApoCell (www.apocell.com) is a privately-held specialty clinical research company. Founded in 2004, the firm is a leader in molecular biomarker detection and analysis, leveraging its expertise in the areas of 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. The company's facilities are CLIA-certified and compliant with applicable FDA regulations. Since inception, the company has participated in over 140 Phase I, II, and III clinical cancer drug trials for more than 80 sponsor clients worldwide.