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Positive Results from FDA Clinical Study
Positive Results from FDA Clinical Study.
About this update from Cellbxhealth Plc
[{"type":"text","content":"\n \nRNS Number : 6723A Angle PLC 31 May 2019 \n\n\n\n\n\n\n\nFor immediate release\n\n\n 31 May 2019\n \n\n\n\n\n\n\n\n\n\n\nANGLE plc (\"the Company\")\n \nPOSITIVE RESULTS FROM FDA CLINICAL STUDY \n \nAnalytical studies ongoing to support FDA submission \n \n \nANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce positive results from its Parsortix FDA clinical study for metastatic breast cancer. \n \nThe 400 subject ANG-002 clinical study (the Study) was designed to support a De Novo submission to the United States Food and Drug Administration (FDA) seeking Class II regulatory clearance for ANGLE's ParsortixTM system for the intended use with metastatic breast cancer patients. \n \nThe Study has achieved its primary objective to demonstrate the ability of the Parsortix system to capture and harvest cancer cells from the blood of a significant proportion of metastatic breast cancer patients. \n \nThe Study has also achieved its exploratory goals by demonstrating that the cells harvested from patient blood using the Parsortix system could be interrogated using different subsequent analysis techniques, including: Wright-Giemsa staining of cytospin preparations for cytopathological evaluation, fluorescent in situ hybridisation (FISH) for evaluation of HER2/neu amplification status, and RT-qPCR for evaluation of cancer related gene expression levels. The harvested cells were also able to be used for the generation of cDNA libraries of sufficient quality for use in RNA-seq evaluation, full bioinformatic analysis is due in June. \n \nANGLE's ongoing discussions with FDA as part of the De Novo process have recently identified additional analytical study experiments that will be needed to support FDA clearance. It is helpful that these requirements have been identified ahead of FDA submission. The additional studies have minimal cost and are expected to be completed to allow FDA submission in early Q4 CY19 offering the prospect of FDA clearance in early CY20. The timing of FDA regulatory clearance is dependent on the FDA's review and response to our submission.\n \nFurther disclosure of data will be reserved to optimise the potential for publication in peer-reviewed journals and to present...