The trial is part of an application for the PillCam Colon 2 capsule to Japan's Pharmaceuticals and Medical Devices Agency in mid-2012.
Given Imaging Ltd. (Nasdaq: GIVN; TASE: GIVN) has initiated a pivotal trial of its PillCam Colon 2 endoscopic capsule in Japan. The trial is part of the company's planned application to Japan's Pharmaceuticals and Medical Devices Agency (PMDA) in mid-2012.
The study will include 72 patients aged 40-75. The study will compare patients with polyps, which have previously been identified by optical colonoscopy, with the PillCam Colon 2 capsule endoscopy procedure. The primary endpoint of the study is identifying polyps greater than or equal to six millimeters in size. Given Imaging expects to complete enrollment of the patients by the end of March 2012.
Given Imaging obtained EU CE Mark for the PillCam Colon 2 in September 2009, and markets the product in Europe, Latin America, Canada, Australia, and parts of Asia. The company says that more than 2,000 patients have undergone PillCam Colon capsule endoscopy.
"Already the leading cause of cancer death in women in Japan and the third-leading cause in men, colorectal cancer continues to impact more of the Japanese population and is projected to be the leading cause of cancer death in Japan within the next 10 years," said Dr. Hisao Tajiri of The Jikei University School of Medicine in Tokyo. "While we know that colorectal cancer can be prevented through screening, compliance rates remain very low in Japan. We welcome additional screening modalities that can help to increase compliance and believe that the benefits offered by PillCam Colon, including the lack of sedation enabling people to continue with normal daily activities, may enable us to do this."
Given Imaging president and CEO Homi Shamir said, "We now have clearances for PillCam Colon in several countries and two important PillCam Colon 2 pivotal trials underway, including an 800 patient multi-center trial in the US, from which we plan on submitting data for regulatory review in 2012. PillCam Colon 2 is recognized by both the GI community and regulatory authorities in Japan as having significant clinical value, and we believe this product can positively impact the low rate of colorectal cancer screening in Japan as well as other countries."
In Japan, more than 42,000 people died from colorectal cancer in 2009. The disease generally can be prevented through early detection.
Given Imaging's share price opened at $16.31 on Nasdaq today, giving a market cap of $486 million, and fell 0.3% to NIS 61.30 by mid-afternoon on the TASE.
Published by Globes [online], Israel business news - www.globes-online.com - on November 15, 2011
© Copyright of Globes Publisher Itonut (1983) Ltd. 2011
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