Catching colon cancer early can mean the difference between life and death. Getting patients to comply with recommended screening however, is a challenge. When DOTmed News heard that Guy Neev, CEO of Check-Cap, was in our neighborhood to ring the closing bell for NASDAQ about a week ago, we saw a great opportunity to discuss this problem. We asked him a few questions about his company — which fittingly went public during Colon Cancer Awareness Month — and why he is so excited about how their product can potentially improve screening compliance.

DOTmed News: What makes the Check-Cap system different from other ingestible imaging capsules on the market?

Guy Neev: Unlike other screening methods that are designed to generate structural information of the colon for the detection of pre-cancerous polyps — such as optical colonoscopy, computed tomographic colonography (CTC), and other capsule-based technology — our imaging capsule is designed to be ingested without any cleansing of the colon and to travel through the gastrointestinal tract naturally while the patient continues his or her normal daily routine.

Because it requires no fasting and allows for normal eating habits, we believe that this solution will be attractive to both physicians and patients, thereby increasing the number of people willing to undergo screening for CRC.

We believe that our imaging capsule could represent a potential breakthrough in CRC screening by providing a structural exam without the pain, discomfort and embarrassment experienced by some patients undergoing a traditional optical colonoscopy and other currently available screening methods by offering the following benefits:

• eliminating the need for fasting and prior bowel cleansing, which would differentiate our imaging capsule from every other currently available structural screening exam;

• providing patients with a procedure that requires them to swallow our capsule and small amounts of a contrast agent, thereby minimizing any disruption to their normal activities;

• eliminating the need to sedate patients;

• obviating the requirement for the insufflation (the forcing of air into the gastrointestinal tract) of patients;

• administering our technology on an outpatient basis;

• providing digital reporting, storage and remote consulting capabilities; and

• enabling a physician to analyze the results in approximately 10 minutes, which would be less time than is required to conduct an optical colonoscopy.

DOTmed News: Can you describe your own background in health care and how you arrived where you are today?

GN: Prior to assuming my position as Check-Cap chief executive officer in 2008, I served as chief executive officer for several early stage medical devices companies, primarily in coronary stents and robotic surgery. Prior to that, I was a cardiovascular business unit manager at Boston Scientific Corporation after being business unit manager at Azimuth Technologies Ltd. and a chief executive officer of its subsidiary, Waycomm Wireless Solutions Ltd. I also served as a major in the Israeli Air Force.

I had always looked for opportunities that change the standard of care. I met with Check-Cap inventor, Dr. Yoav Kimchy in 2007 and thought this was one of those ideas that could really change cancer care and save so many lives. I myself realized how invasive and unpleasant traditional colonoscopy is and strongly believe that a non-invasive modality like the check-cap imaging system could make a very significant impact on the colon cancer screening market, which would eventually save many lives.

DOTmed News: How has policy informed routine colon screening? Are there any trends you've noticed in recent years?

GN: CRC screening can reduce death rates from CRC both by preventing the disease and by detecting it at earlier more treatable stages. CRC is one of the few cancers that can be prevented through screening because pre-cancerous polyps, from which colon cancers usually develop, can be identified and removed. The five-year survival rate is greater than 90 percent for CRC patients diagnosed at an early, localized stage.

However, less than 40 percent of cases are currently diagnosed at that stage. According to the CDC, at least 6 out of every 10 deaths from CRC could be prevented if every adult age 50 years or older was screened regularly and that approximately 30,000 lives could be saved each year in the United States if the screening recommendations were followed. The ACS’s goal is to have 80% of those 50 years and older who are covered by the program screened by 2018.

The ACS recommends that men and women over the age of 50 receive an optical colonoscopy every 10 years or other structural test, such as sigmoidoscopy or virtual colonoscopy, every five years or alternatively, FOBT should be performed every year. According to the U.S. Census Bureau, as of mid-2014, there were projected to be approximately 91 million Americans aged 50-75 years. Assuming the longest screening interval of 10 years, the addressable annual U.S. patient population is at least 9.1 million.

Despite evidence supporting the effectiveness of CRC screening and the availability of various screening tests, in 2010, approximately 58.6 percent of Americans 50 years and older had been screened for CRC, according to the CDC. This compares unfavorably to 72 percent to 83 percent for screening of other types of cancers, such as breast and cervical cancer. The CRC screening rates are even lower among people aged 50 to 64 according to the CDC.

In the 2008 ACS guidelines for CRC screening in average risk-adults, titled “A Joint Guideline from the American Cancer Society, the U.S. Multi-Society Task Force on CRC, and the American College of Radiology”, screening tests were grouped into those that primarily detect cancer early and those that can detect both early cancer and adenomatous polyps. The latter provide greater potential for prevention through removal of polyps, or polypectomy.

The panel recommended that, when possible, clinicians should make patients aware of the full range of screening options, but at a minimum they should be prepared to offer patients a choice between a screening test that is effective at both early cancer detection and cancer prevention through the detection and removal of polyps and a screening test that is primarily effective at early cancer detection.

It was the opinion of the panel that colon cancer prevention should be the primary goal of CRC screening. Tests that are designed to detect both early cancer and adenomatous polyps should be encouraged if resources are available and patients are willing to undergo an invasive test. These tests include the partial or full structural exams mentioned above. These tests require bowel preparation and an office or hospital visit and have various levels of risk to patients. These tests also have other limitations, including greater patient requirements for successful completion, and potential harm to the patients.

DOTmed News: Does Check-Cap have a timeline in mind for getting marketing clearances?

GN: We hope to submit before the end of the year a request for CE marking for the marketing and sale of our capsule in the European Union. We expect to perform post-marketing studies in Europe following CE marking for the purpose of collecting additional clinical data. Subject to regulatory approval and available capital, we anticipate launching our product commercially in Europe during 2016. We plan to conduct a second pre-IDE meeting with the FDA in late 2015, and subsequently to submit a request for the approval of an IDE for a pivotal study in the United States.

We anticipate that the FDA approval for the pivotal study will be subject to our providing sufficient clinical data from the multi-center, prospective clinical feasibility study. We also intend to pursue clinical trials for regulatory approvals in Japan and China in parallel to the U.S. pivotal study. Pivotal studies are expected, among other things, to compare the images of polyps identified by our imaging system with the same polyps detected by traditional optical colonoscopy and CTC in instances where patients were referred after positive exam results.

These clinical findings will be analyzed in comparison with results obtained from FOBTs and FITs. Subject to the successful completion of our clinical trials and the receipt of initial FDA approval for the marketing of our imaging capsule in the United States, our goal is to launch our product commercially in the United States during 2017.

DOTmed News: On March 31st, the last day of Colon Cancer Awareness Month, you rang the closing bell at NASDAQ. How can medical professionals get through to the general public about the importance of cancer screening?

GN: I find it very symbolic that Check-Cap was chosen to close the trade in NASADQ on the last day of Colon Cancer Awareness Month. Colorectal cancer screening saves lives. It is one of only a few cancers that can be prevented through screening. The risk of developing colorectal cancer increases with advancing age. More than 90 percent of cases occur in people aged 50 or older.

Building awareness is the most important part of helping to increase screening and decrease mortality rates. Colorectal cancer, second only to lung cancer as the leading cause of cancer deaths in the United States, effects men and women equally. Yet few Americans know that colorectal cancer can be prevented — not just detected. Colorectal cancer arises from pre-cancerous growths or polyps that grow in the colon, which, when detected early, can be removed, halting their progression to colorectal cancer. Under-use of proven screening tests – especially among Medicare beneficiaries: 1 in 3 adults – almost 23 million Americans between 50 and 75 years old – is not getting tested for colorectal cancer as recommended. The key is education and the emphasis on the fact that we aren't looking only for cancer but rather for pre-cancerous polyps, which, when removed, could prevent cancer.