ISFIYA, Israel, Oct. 18, 2016 /PRNewswire/ -- Check-Cap Ltd.
(Nasdaq: CHEK, CHEKW), a clinical stage medical diagnostics company
engaged in the development of an ingestible capsule for
preparation-free, colorectal cancer screening, today announced
additional clinical data on the Company's minimally-invasive system
was presented at the American College of Gastroenterology (ACG)
Annual Scientific Meeting taking place October 14-19 in Las
Vegas, and at the United European Gastroenterology Week
(UEGW) taking place October 15-19 in
Vienna.
During ACG, a video abstract entitled "A Preparation-Free X-Ray
Imaging Capsule for Colon Cancer Screening" presented case studies
on the use of the system in three patients enrolled in the
Company's ongoing clinical feasibility study. Clinical review
showed the system's viewing modes to examine the inner surface of
colon segments in order to identify and locate flat sessile and
pedunculated polyps that were confirmed by optical colonoscopy.
"Although colorectal cancer is the second leading cause of
cancer deaths in the U.S., rigorous evidence suggests that better
screening adherence can lead to significantly improved
survival rates," said study presenter Seth
A. Gross, M.D., Associate Professor and Chief of
Gastroenterology at Tisch Hospital, NYU Langone Medical Center.
"These data reinforce previous findings that a non-invasive,
preparation-free alternative to traditional optical colonoscopy may
be a safe and effective alternative for the significant portion of
the population who do not currently undergo routine screening
evaluation."
A poster presentation at UEGW entitled "A Novel Preparation-Free
X-Ray Imaging Capsule for Colon Cancer Screening: Correlation
between Capsule and Colonoscopic Clinical Findings" provided an
update on preliminary data from the Company's ongoing clinical
feasibility study evaluating the Check-Cap system in 66 volunteers
aged 41-74 years. The study tracked the entire passage of the
capsule through the alimentary tract using radio frequency
telemetry and Check-Cap's proprietary capsule position tracking
system. Findings from the study demonstrated the capability of the
system to identify polyps and provide segmental location and
morphology information, as confirmed by colonoscopy. All capsules
were swallowed naturally without adverse events and excreted after
an average transit time of 62 hours. Enrolled subjects were exposed
to ultra-low doses of radiation with an average total exposure of
0.06 ± 0.04 mSv. While colonic polyps were clearly identified and
reconstructed by the system, the efficacy of this colon screening
modality will be further evaluated in planned multi-center
studies.
Check-Cap anticipates submitting data from this study for CE
Marking in the first half of 2017 and initiating a U.S. pivotal
trial in 2018.
"While the benefits of colorectal cancer screening are well
documented in clinical literature and re-enforced in screening
guidelines, there are several significant barriers, including
resistance to bowel preparation, that continue to deter many of the
average-risk population," said Bill
Densel, CEO of Check-Cap. "We are developing the Check-Cap
system to offer an alternative modality that may help increase
screening rates by addressing the perceived drawbacks of existing
methodologies that may serve as obstacles to screening for a
significant segment of the population."
About Check-Cap
Check-Cap is a clinical-stage medical diagnostics company
developing the world's first ingestible capsule system for
preparation-free, minimally-invasive colorectal cancer
screening.
The capsule utilizes innovative ultra-low dose X-ray and
wireless communication technologies to scan the inside of the colon
as it moves naturally, while the patient follows his or her normal
daily routine. After passage, the system generates a 3D
map of the inner surface of the colon which enables detection of
polyps and cancer. Designed to increase the willingness of
individuals to participate in recommended colorectal cancer
screening, the Check-Cap system addresses many frequently-cited
barriers, including laxative bowel preparation, invasiveness, and
sedation. The Check-Cap 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
David Carey
Lazar Partners Ltd.
212-867-1768
dcarey@lazarpartners.com
Vivian Cervantes
PCG Advisory
212-554-5482
vivian@pcgadvisory.com
Media
Erich Sandoval
Lazar Partners Ltd.
917-497-2867
esandoval@lazarpartners.com
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SOURCE Check-Cap Ltd.