ISFIYA, Israel and BOSTON, Sept. 27,
2017 /PRNewswire/ --Check-Cap Ltd. (the "Company" or
"Check-Cap") (NASDAQ: CHEK) (NASDAQ: CHEKW), a clinical-stage
medical diagnostics company engaged in the development of
C-Scan®, an ingestible capsule for preparation-free,
colorectal cancer screening, today announced that it has filed for
the CE Mark registration of C-Scan. Data from the multi-center
clinical investigation to support the submission showed safety and
encouraging results for detecting patients with polyps in an
un-prepped colon.
The objective of the study was to assess safety and the clinical
performance of C-Scan in detecting patients with polyps. The
three-center trial enrolled 66 patients, with a mean age of 59
years. Following capsule ingestion, subjects swallowed small doses
of contrast agent and fiber supplements with each meal throughout
capsule passage. Average capsule transit time was 52±32 hours, and
the average total X-ray dose was 0.05 mSv (CT colonography
effective dose is ~ 6.0 mSv). No bowel preparation, sedation,
or change in diet was required. Both confirmatory
colonoscopy, performed by an independent investigator, and C-Scan
review, performed by a central review group, were blinded to
results.
The study demonstrated a 44% sensitivity in the 45 subjects
included in the analysis for polyps, with specificity of 89%.
Sensitivity strongly correlated (R-squared = 0.98) to the
percentage of the colon scanned. Sensitivity was 78%
(p<0.05) and 100% (p<0.05) for subjects where greater than
50% and 70% of the colon was scanned, respectively.
Specificity was consistent for all subjects.
Professor Nadir Arber, Principal
Investigator and Prof. of Internal Medicine and Gastroenterology
and Head of the Health Promotion Center and Integrated Cancer
Prevention Center at the Tel-Aviv Sourasky Medical Center, stated:
"These clinical results demonstrate C-Scan's positive safety
profile and strong correlation between detection of patients with
polyps and capsule scan coverage. Top line accuracy
results are rather encouraging as well, as the sensitivity for
advanced adenomas by stool testing, the primary colorectal cancer
screening test in EU, demonstrates sensitivity ranges of 22% to
40%." Prof. Arber continued, "Despite evidence suggesting
that polyp detection and removal can decrease CRC incidence and
mortality, screening adherence remains disappointingly low. Many
patients are unwilling to choose standard tests due to unpleasant
bowel preparation requirements or stool collection. The
promise of C-Scan is to provide a more patient-friendly option
which could potentially increase screening rates. We look forward
to additional research evaluating C-Scan for colonic polyp
detection."
Colorectal cancer is the second leading cause of cancer death in
the U.S., with an estimated 135,000 diagnoses and 50,000 deaths in
2017. Despite compelling evidence that screening can detect
colorectal cancer and precancerous polyps, nearly one-third of the
recommended adult population has never been screened. The C-Scan®
system is designed to improve the patient experience with screening
by eliminating many unattractive requirements, such as bowel
preparation, fasting, and sedation.
Bill Densel, CEO of Check-Cap,
commented: "Submission of the CE Mark application marks an
important milestone for Check-Cap, and we are pleased with the
achievements made in the clinical performance of C-Scan, as
demonstrated in the multi-center, comparative trial. Our
system was shown to be safe and capable of identifying polyps for
removal in patients with no bowel preparation. We are
underway with the clinical evaluation of our advanced C-Scan
version, incorporating improvements to software algorithms."
Mr. Densel concluded, "We are committed to developing an
alternative to today's invasive and preparation-intensive
approaches to colorectal cancer prevention. We look forward to EU
post market initiation and US pilot trial, expected to begin in the
first half of 2018."
Conference Call and Webcast Information
Check-cap will host a management conference call today at
9:00 a.m. EDT. To access the
conference call, please dial 1-877-317-6789 from the U.S. or
1-412-317-6789 internationally. The call will also be available via
webcast and can be accessed through the Investor Relations page of
Check-cap's website. Please allow extra time prior to the call to
visit the site and download any necessary software to listen to the
live broadcast.
A replay of the conference call will be available approximately
one hour after completion of the live conference call at the
Investor Relations page of Check-cap's website. A dial-in replay of
the call will be available until October 11,
2017; please dial 1-877-344-7529 from the U.S. or
1-412-317-0088 internationally and use the access code:
10112630.
About Check-Cap
Check-Cap is a clinical-stage medical diagnostics company
developing C-Scan®, the first capsule-based system for
preparation-free colorectal cancer screening.
Utilizing innovative ultra-low dose X-ray and wireless
communication technologies, the capsule generates information on
the contours of the inside of the colon as it passes
naturally. This information is used to create a 3D map of the
colon, which allows physicians to look for polyps and other
abnormalities. Designed to improve the patient experience and
increase the willingness of individuals to participate in
recommended colorectal cancer screening, C-Scan removes many
frequently-cited barriers, such as laxative bowel preparation,
invasiveness and sedation. The C-Scan system is currently not
cleared for marketing in any jurisdiction.
Legal Notice Regarding Forward-Looking Statements
This press release contains "forward-looking statements." Words
such as "may," "should," "could," "would," "predicts," "potential,"
"continue," "expects," "anticipates," "future," "intends," "plans,"
"believes," "estimates," and similar expressions, as well as
statements in future tense, often signify forward-looking
statements. Forward-looking statements should not be read as a
guarantee of future performance or results and may not be accurate
indications of when such performance or results will be achieved.
Forward-looking statements are based on information that the
Company has when those statements are made or management's good
faith belief as of that time with respect to future events, and are
subject to risks and uncertainties that could cause actual
performance or results to differ materially from those expressed in
or suggested by the forward-looking statements. For a discussion of
these and other risks that could cause such differences and that
may affect the realization of forward-looking statements, please
refer to the "Special Note On Forward-looking Statements" and "Risk
Factors" in the Company's Annual Report on Form 20-F and other
filings with the Securities and Exchange Commission (SEC).
Investors and security holders are urged to read these documents
free of charge on the SEC's web site at http://www.sec.gov. The
Company assumes no obligation to publicly update or revise its
forward-looking statements as a result of new information, future
events or otherwise.
CONTACT
Investors
Vivian
Cervantes
PCG Advisory
212-554-5482
vivian@pcgadvisory.com
David Carey
Lazar Partners Ltd.
212-867-1768
dcarey@lazarpartners.com
Media
Erich Sandoval or
Rob Sawyer
Lazar Partners Ltd.
917-497-2867 or 212-843-0209
esandoval@lazarpartners.com
rsawyer@lazarpartners.com
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SOURCE Check-Cap Ltd.