Angle has enrolled first patient in its ANG-002 FDA clinical study for metastatic breast cancer.
The firm is seeking to become the first ever company to receive FDA Class II clearance for a product for harvesting intact circulating tumor cells (CTCs) from patient blood for subsequent analysis1.
The successful start of this study is the culmination of an enormous amount of work to develop, test and finalise the protocols involved and secure all of the necessary approvals for the clinical study.
There were significant technical issues that had to be addressed in relation to the downstream analysis techniques. Optimisation of the techniques used to analyse cells harvested by the Parsortix system has required the development of know-how which, now successfully completed, adds to the overall capability and differentiation of the Parsortix system in the market.
FDA clearance is the de facto global gold standard for in vitro diagnostic tests as well as a legal requirement for sale of the product for the intended clinical use in the United States.
Securing FDA clearance has the potential to differentiate ANGLE in the liquid biopsy market, validating the clinical and analytical performance of the system and thereby positively influencing Parsortix system adoption worldwide.
The clinical study involves recruitment of 200 metastatic breast cancer patients and 200 healthy volunteers enrolled at leading US cancer centres and is designed to support potential clearance by the FDA for the following intended use:
"The ParsortixTM PC1 instrument is an in vitro diagnostic device intended to harvest circulating tumor cells (CTCs) from the peripheral blood of patients diagnosed with metastatic breast cancer. Harvested CTCs can be used in subsequent analyses."
The primary endpoint of the clinical study, being led by MD Anderson, is the cytological evaluation of harvested cells confirming that CTCs are harvested from metastatic breast cancer patients but not from healthy volunteers.
The exploratory endpoints are to demonstrate that, in addition to the cytological evaluation, the Parsortix harvested cells can be analysed using quantitative PCR (qPCR, MD Anderson), fluorescence in situ hybridisation (FISH, University of Southern California) and whole transcriptome sequencing (RNA-Seq, University of Southern California).
As announced on 6 February 2018, ANGLE has signed an agreement with the global healthcare company Abbott to use its proprietary PathVysion HER-2 DNA FISH Probe kits in the study. Abbott is the global market leader for FISH testing in solid tissue biopsies. A positive result in this clinical study would demonstrate the potential for Abbott to offer a Parsortix-based product for HER-2 analysis from a routine blood test.
The enrolment of the patients and healthy volunteers are under the direct control of the independent cancer centres and outside the control of the Company. Once the rate of enrolment and general progress of the clinical study becomes clear we will update the market on likely timescales. Current expectations continue to be that both the clinical study and the associated analytical studies will complete in H2 CY 2018.
Angle founder and chief executive Andrew Newland said: "We believe there is a tremendous opportunity for ANGLE to secure the first ever FDA Class II clearance for harvesting intact circulating tumor cells from patient blood for subsequent analysis.
“This would be a key step in establishing the Parsortix system as the system of choice for CTC liquid biopsy securing a leading position in the emerging multi-billion dollar liquid biopsy market. The FDA clearance process is highly technically challenging. ANGLE has successfully met the many challenges involved in establishing the study and we are now into the next stage of executing the clinical study. “
Source: Company Press Release