TIDMAGL
RNS Number : 9768D
Angle PLC
03 May 2017
For immediate release 3 May 2017
ANGLE plc ("the Company")
BUSINESS UPDATE HIGHLIGHTS PROGRESS WITH PARSORTIX LIQUID
BIOPSY
Ovarian cancer clinical studies progressing well with patient
enrolment completed. Headline data on target for reporting this
quarter
MD Anderson Cancer Center signed as the lead cancer centre for
the FDA clinical study and related analytical study progressing
well
Parsortix user base grows and recognition of utility expands
ANGLE plc (AIM:AGL OTCQX:ANPCY), the specialist medtech company,
is pleased to provide a business update following the close of its
financial year ended 30 April 2017.
Ovarian Cancer Studies
The Company's first clinical application for Parsortix is being
progressed with two clinical studies in ovarian cancer: ANG-001 in
Europe (200 patients) and ANG-003 in the United States (200
patients). The Company has made good progress in these studies and
patient enrolment is now complete in both. A few patients remain to
have their abnormal pelvic mass surgically removed and/or the
removed tissue to be analysed to confirm the presence or absence of
tumour cells. The studies will then be un-blinded and an
independent statistical evaluation of the predictive power of the
Parsortix clinical application will be undertaken. The headline
data is on track for reporting this quarter (Q2 CY17).
FDA Clearance
The Company has successfully completed fundamental aspects of
the FDA analytical study and the remaining tasks are in progress.
The FDA clinical study, ANG-002 in metastatic breast cancer, has
passed formal Scientific Review Committee approval and The
University of Texas MD Anderson Cancer Center has been signed as
the lead cancer centre for analysis of the primary endpoint and one
of the secondary endpoints for the study. ANGLE has engaged with
IRBs (institutional review boards) at six US cancer centres to
provide patient samples and to process these with Parsortix for
subsequent analysis. The studies remain on track for completion by
the end of CY17.
Research
Over 30,000 blood separations have now taken place with
Parsortix, up from c. 15,000 at 30 April 2016. The installed base
of Parsortix instruments is continuing to grow, standing at over
145 at 30 April 2017, up from c. 85 at 30 April 2016. Adoption of
Parsortix into the customers' routine laboratory practice is
evident from a substantial increase in revenues from cassette
sales, which are up over 500% from last year. Overall revenues for
the year are up over 40% and sales are expected to be c. GBP0.5
million for the year. Our sales team continue to focus on
supporting our customers as they evaluate Parsortix in their
current laboratory procedures, and we have seen a cumulative
conversion rate for evaluations to sales of over 75%. However
evaluations have taken longer to close than expected generally
because of limitations in analytical techniques outside the
Parsortix system. At present, there are a further 20 prospective
customers evaluating Parsortix systems with a view to purchase. The
Directors believe that the conversion rates to date and the number
of institutions currently engaged point to a positive profile of
growth in research use for Parsortix.
The cash position at 30 April 2017 is c. GBP5.5 million, which
is broadly in line with plans despite having established higher
inventory balances than planned and an outstanding payment due to
the Company in relation to an R&D tax credit.
ANGLE Founder and Chief Executive, Andrew Newland,
commented:
"We are continuing to make good progress against the Company's
key milestones. We are delighted that the #1 ranked cancer centre
in the United States, MD Anderson Cancer Center, is leading our FDA
clinical study. We look forward to the results of our clinical
studies in ovarian cancer as clear demonstration of the value of
Parsortix in the clinical setting. Success in these clinical
studies would mark a major step forward in the validation of the
Parsortix technology and for ANGLE as a key participant in the
rapidly growing multi-billion dollar liquid biopsy market."
For further information:
ANGLE plc 01483 685830
Andrew Newland, Chief Executive
Ian Griffiths, Finance Director
Cenkos Securities
Stephen Keys (Nominated adviser),
Steve Cox
Russell Kerr (Sales) 020 7397 8900
WG Partners
David Wilson
Claes Spång 020 3705 9330
FTI Consulting
Simon Conway, Mo Noonan,
Stephanie Cuthbert 020 3727 1000
Kimberly Ha (US) 001 212 850 5612
For Frequently Used Terms, please see the Company's website on
http://www.angleplc.com/the-parsortix-system/glossary/
This announcement contains inside information.
Notes for editors
About ANGLE plc www.angleplc.com
ANGLE is a specialist medtech company commercialising a
disruptive platform technology that can capture cells circulating
in blood, such as cancer cells, even when they are as rare in
number as one cell in one billion blood cells, and harvest the
cells for analysis.
ANGLE's cell separation technology is called the Parsortix(TM)
system and it enables a liquid biopsy (simple blood test) to be
used to provide the cells of interest. Parsortix is the subject of
granted patents in Europe, the United States, Canada, China, Japan
and Australia and three extensive families of patents are being
progressed worldwide. The system is based on a microfluidic device
that captures live cells based on a combination of their size and
compressibility. Parsortix has a CE Mark for Europe and FDA
authorisation is in process for the United States.
ANGLE has established formal collaborations with world-class
cancer centres. These Key Opinion Leaders are working to identify
applications with medical utility (clear benefit to patients), and
to secure clinical data that demonstrates that utility in patient
studies. Details are available here
http://www.angleplc.com/the-company/collaborators/
The analysis of the cells that can be harvested from patient
blood with ANGLE's Parsortix system has the potential to help
deliver personalised cancer care offering profound improvements in
clinical and health economic outcomes in the treatment and
diagnosis of various forms of cancer.
The global increase in cancer to a 1 in 3 lifetime incidence is
set to drive a multi-billion dollar clinical market. The Parsortix
system is designed to be compatible with existing major medtech
analytical platforms and to act as a companion diagnostic for major
pharma in helping to identify patients that will benefit from a
particular drug and then monitoring the drug's effectiveness.
As well as cancer, the Parsortix technology has the potential
for deployment with several other important cell types in the
future.
ANGLE stock trades on the AIM market of the London Stock
Exchange under the ticker symbol AGL and in New York on the OTC-QX
under the ticker symbol ANPCY. For further information please
visit: www.angleplc.com
About MD Anderson Cancer Center
The University of Texas MD Anderson Cancer Center has ranked No.
1 for cancer care by U.S. News & World Report's annual "Best
Hospitals" rankings. Since the rankings began in 1990, MD Anderson
Cancer Center has been named one of the top two cancer hospitals in
the United States every year and has received the top position nine
times in the last 10 years.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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