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Advanced Cell Diagnostics' RNAscope Technology Supports Biomarker-Selected Phase 2 Clinical Trial of Merrimack Pharmaceuticals' MM-121

publication date: Apr 1, 2015
author/source: Advanced Cell Diagnostics

Advanced Cell Diagnostics, Inc. (ACD) announced today that Merrimack Pharmaceuticals, Inc. is using ACD's RNAscope technology to select patients for its Phase 2 clinical trial of its product candidate MM-121.

ACDMerrimack will utilize RNAscope to identify patients with heregulin positive, locally advanced or metastatic non-small cell lung cancer, making this Merrimack's first MM-121 trial to include only patients with a high heregulin biomarker profile. In previous MM-121 Phase 2 clinical trials, heregulin-positive patients, determined by RNAscope, have demonstrated significant therapeutic benefits when treated with a combination of MM-121 and standard therapies.

“Our selection of the RNAscope-based heregulin test for this clinical trial is the culmination of multiple clinical studies in which we evaluated RNAscope. These trials have repeatedly demonstrated the potential of heregulin as a promising biomarker in predicting the therapeutic benefits of MM-121." stated Gavin MacBeath, Senior Vice President of Translational Research at Merrimack. "We believe that the high sensitivity and specificity that RNAscope provides are necessary to identify the patients most likely to benefit from MM-121 in this Phase 2 clinical trial. RNAscope's ability to detect heregulin within the confines of tumor cells, compatibility with existing automation instruments and with small tissue specimens such as fine needle aspirates and core needle biopsies were all important considerations in our decision to work with ACD."

"We are delighted that Merrimack has selected RNAscope as the biomarker platform for their MM-121 clinical program. This marks the first of many examples of RNAscope's adoption to support the development of companion diagnostic tools for pharma and biotech companies. We believe that RNAscope's robust capabilities and open platform make it an ideal foundation on which to develop highly capable CDx solutions that maximize trial efficiency by enabling drug developers to more effectively zero-in on those patients most likely to benefit." said Dr. Yuling Luo, Founder, President and CEO of ACD.

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