RNS - FDA on track again22 Jun 2020 08:13
Angle PLC Blood donations recommenced for FDA studies
Source: UK Regulatory (RNS & others)
TIDMAGL
RNS Number : 5697Q
Angle PLC
22 June 2020
For immediate release 22 June 2020
ANGLE plc ("the Company")
BLOOD DONATIONS RECOMMENCED FOR FDA ANALYTICAL STUDIES
Ovarian cancer study patient enrolment recommenced
All aspects of ANGLE business operational again
ANGLE plc (AIM:AGL OTCQX:ANPCY), a world-leading liquid biopsy company, is delighted to announce that blood donations have recommenced in support of ANGLE's FDA analytical studies and for patient enrolment in its pivotal ovarian cancer study.
As announced on 31 March 2020, completion of ANGLE's remaining analytical studies in support of its US Food and Drug Administration (FDA) submission for Parsortix(R) had to be ceased as a result of UK Government COVID-19 lock down measures preventing blood donations from healthy volunteers. Similar restrictions in the United States impacted patient enrolment at University of Rochester Medical Centre, New York for our ovarian cancer study there.
US FDA Submission
In response to UK Government relaxation of the COVID-19 lock down rules and extensive work by ANGLE to address new health and safety guidelines, complete required risk assessments, ensure compliance with our formal ethics approval for drawing blood, and meet other ethical, insurance and legal considerations, blood donations from healthy volunteers are again being processed at ANGLE's Guildford, UK facility. The work undertaken by ANGLE in support of this has been extensive and included re-purposing part of our facilities to provide physical segregation, establishing double shift working to enable social distancing, and instituting PPE and other additional safety protocols to protect staff and donors alike.
The blood samples are used for various development activities, the most important of which is completion of the remaining analytical studies in support of ANGLE's submission to the FDA; where we are seeking the first ever FDA regulatory clearance for a simple blood test to harvest cancer cells for analysis, initially in metastatic breast cancer.
The FDA analytical studies have specific requirements for healthy volunteer blood donations, which must be met to be valid for the FDA process. These include:
-- using fresh blood processed within 8 hours of blood draw;
-- ensuring the appropriate demographic of donors - we have a particular need for women over the age of 50;
-- ensuring blood donations are available at the right time of day - we need blood donors all day from 6am onwards to meet the new double shift requirement that we have implemented;
-- obtaining blood donations in sufficient numbers to be confident of successful completion of the required FDA analytical studies - these cannot be completed in a piece-meal fashion and have to be completed according to strict analytical protocols in order to be valid for their purpose
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