Full De Novo FDA Submission expected in Q1 CY20
Prospect of FDA clearance in Q3 CY20
GUILDFORD, SURREY / ACCESSWIRE / January 22, 2020 / ANGLE plc (AIM:AGL)(OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce that a successful face-to-face meeting with the FDA took place last week. As a result, ANGLE is proceeding with the preparation of the full De Novo FDA Submission for Parsortix®.
After completion of clinical and analytical studies demonstrating the performance of the Parsortix system for harvesting circulating tumour cells in metastatic breast cancer, ANGLE made a substantial Q-Submission (a "pre-submission" used to request formal comment from FDA on key questions) to FDA on 29 October 2019. This set out headline data from both the clinical and analytical studies and requested FDA formally respond to a series of questions from ANGLE, including whether our responses to specific questions which FDA had previously raised were acceptable. ANGLE's intention in making this Q-Submission was to reduce the risk that the full FDA De Novo Submission might be rejected and to identify any additional work that may be required earlier in the process.
FDA provided a formal written response to ANGLE's Q-Submission in advance of the formal face-to-face meeting with ANGLE held last week to discuss this response. Following the success of this meeting, ANGLE is now able to prepare a full De Novo FDA Submission to FDA requesting clearance of the Parsortix system for use in metastatic breast cancer. While some additional analytical study work was requested by FDA, this will be undertaken in parallel with the submission drafting and have no impact on the overall timescales and incur de-minimis additional cost.
Whilst significant work remains to complete the written submission, which is expected to run to several thousand pages, all of which will be subject to substantive review and questioning by FDA, ANGLE believes that all of the critical issues were addressed in the meeting and that there is now a clear route to full De Novo FDA Submission.
ANGLE is progressing the full De Novo FDA Submission as quickly as possible with the aim of making a submission in Q1 CY20 with the prospect of FDA clearance in Q3 CY20 (unchanged). The outcome and timing of any FDA regulatory decision is entirely dependent on FDA's review and response to the Company's submission.
ANGLE Founder and Chief Executive, Andrew Newland, commented:
"We are delighted with the ongoing positive discussions with FDA and that there is a clear route for the full De Novo FDA Submission. We believe there is a tremendous opportunity for ANGLE to secure the first ever FDA clearance for a platform that captures and harvests intact circulating tumour cells from patient blood for subsequent analysis, in the first instance for metastatic breast cancer. We believe that FDA regulatory clearance, considered the gold standard for approval of medical diagnostic systems globally, would further competitively differentiate our Parsortix liquid biopsy system and should lead to an acceleration in commercial adoption of the system in both research and clinical settings."
For further information ANGLE:
ANGLE plc | +44 (0) 1483 343434 |
Andrew Newland, Chief Executive | |
finnCap Ltd (NOMAD and Joint Broker) | +44 (0)20 7220 0500 |
WG Partners (Joint Broker) |
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FTI Consulting |
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The information communicated in this announcement is inside information for the purposes of Article 7 of Regulation 596/2015.
For Frequently Used Terms, please see the Company's website on http://www.angleplc.com/the-parsortix-system/glossary/
Notes for editors
About ANGLE plc www.angleplc.com
ANGLE is a world leading liquid biopsy company with sample-to-answer solutions. ANGLE's proven patent protected platforms include a circulating tumor cell (CTC) harvesting technology and a downstream analysis system for cost effective, highly multiplexed analysis of nucleic acids and proteins.
ANGLE's cell separation technology is called the Parsortix® system, and it enables a liquid biopsy (a simple blood test) to be used to provide the cells of interest to the user in a format suitable for multiple types of downstream analyses. The system is based on a microfluidic device that captures cells based on a combination of their size and compressibility. The system is epitope independent and can capture all types of CTCs as well as CTC clusters in a viable form (alive). CTCs enable the complete picture of a cancer to be seen as being a complete cell they allow DNA, RNA and protein analysis and the live cells harvested can be cultured. The Parsortix technology is the subject of 24 granted patents in Europe, the United States, China, Australia, Canada, India, Japan and Mexico with three extensive families of patents are being progressed worldwide. The Parsortix system has a CE Mark in Europe for the indicated use and FDA clearance is in process for the United States with a 400 subject clinical study and associated analytical studies in metastatic breast cancer. ANGLE is seeking to be the first ever FDA cleared CTC harvesting system and only the third ever FDA cleared liquid biopsy test.
ANGLE has established formal collaborations with world-class cancer centres and major corporates such as Abbott, Philips and QIAGEN, and works closely with leading CTC translational research customers. These Key Opinion Leaders (KOLs) are working to identify applications with medical utility (clear benefit to patients), and to secure clinical data that demonstrates that utility in patient studies. The body of evidence as to the benefits of the Parsortix system is growing rapidly from our own clinical studies in metastatic breast cancer and ovarian cancer and also from KOLs with 26 peer-reviewed publications and numerous publicly available posters, available on our website.
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SOURCE: ANGLE plc
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