Angle reveals positive results from latest Parsortix study

The AIM-traded firm said the 400 subject ANG-002 clinical study was designed to support a De Novo submission to the United States Food and Drug Administration (FDA), seeking Class II regulatory clearance for its Parsortix system, for the intended use with metastatic breast cancer patients.

It said the study 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.

The study 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.

Angle said the harvested cells were also able to be used for the generation of cDNA libraries of sufficient quality for use in RNA-seq evaluation, with full bioinformatic analysis due in June.

It said its ongoing discussions with the FDA as part of the De Novo process had recently identified additional analytical study experiments that would be needed to support regulatory clearance.

It said it was “helpful” that those requirements were identified ahead of FDA submission.

The additional studies had minimal cost, and were expected to be completed to allow FDA submission early in the fourth quarter, offering the prospect of FDA clearance in early 2020.

Angle said the timing of FDA regulatory clearance was dependent on the FDA's review and response to its submission.

“We are delighted with the positive results from the FDA clinical study,” said Angle founder and chief executive officer Andrew Newland.

“We are working to complete the remaining analytical study work and the full data analysis and interpretation so that an FDA submission can be made as soon as possible.”

Newland said the company believed there was a “tremendous opportunity” for Angle to secure the first ever FDA clearance for a platform that captured and harvests intact circulating tumour cells from patient blood for subsequent analysis, in the first instance for metastatic breast cancer.

“This clearance, considered the gold standard for approval of medical diagnostic systems globally, would further competitively differentiate the Parsortix system and should lead to an acceleration in commercial adoption of the system in both research and clinical settings.”