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Aries Pharmaceuticals, Inc. Shares Positive Results for Clinical Study of Eleview™ at Digestive Disease Week Annual MeetingAries Pharmaceuticals, Inc. (Aries), a specialty pharmaceutical company commercializing best-in-class gastroenterology products, shared positive results of the first Eleview™ clinical trial in humans at the annual Digestive Disease Week (DDW) conference in Chicago, Illinois earlier this month. Eleview is a novel, ready to use, methylene blue containing, submucosal injectable composition for use in the easy and safe endoscopic removal of polyps, adenomas, and early stage cancers, and other lesions in the gastrointestinal (GI) tract. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170518005430/en/ Eleview (Photo: Business Wire). The product, which is packaged as a set of five 10 mL single use, sterile ampoules with a luer lock closure that can easily be connected to a suitable syringe, was also unveiled for the first time. The "Twist and Go" ampoules enable endoscopists to quickly access Eleview when needed without having to wait for compounding and eliminate product waste should a lesion not be identified during the procedure. Eleview is administered through an endoscope via a normal, commercially available endoscopic injection needle. The goals of the study were to assess the comparative effectiveness and safety of Eleview versus standard saline plus methylene blue (saline admixture) in patients undergoing Endoscopic Mucosal Resection (EMR) of colonic lesions =20 mm. While not powered for statistical significance, several efficacy endpoints did demonstrate significance and all others trended positively for Eleview. Study Results Data presented at the meeting positively demonstrated both efficacy and safety for Eleview when compared to saline plus methylene blue. The three primary efficacy endpoints were all positive for the Eleview arm of the study:
The safety data is interim given that some patients have not yet reached their 60-day post-procedure follow-up exam. To date, no substantial differences in the number of complications between Eleview and the comparator saline admixture arm were seen. The study results so far suggest that Eleview is at least as safe as the comparator saline in terms of procedural complications. "The results of this study helped to demonstrate clear procedural advantages over saline and that's great news for patients and clinicians -- and potentially also the healthcare system," noted David Kriesel, Executive Director of Medical Affairs. "A key differentiator for Eleview is the fact that it's premixed and ready-to-use. Unlike the current standard of care of saline admixed with methylene blue and/or other components, Eleview's convenient ready-mixed packaging can save procedure time by not having to order the admixture to be compounded either before or during the procedure. We're excited to now offer the product in the United States, and look forward to working with endoscopists to increase access nationwide." The study helps to reinforce the benefits Eleview presents for gastroenterologists and patients. Upon injection, the product forms an immediate cushion of optimal shape, height, and duration. The inclusion of methylene blue, a contrast dye, improves visibility of the lesion. By providing an immediate and long-lasting cushion beneath the polyp and improving the visibility of the lesion, Eleview helps endoscopists achieve a complete and safe removal of the lesion. When compared to saline, one of the most commonly used agents and used as the comparator arm with the addition of methylene blue in the above study, Eleview demonstrated better cushion-forming ability and a duration of lift of up to 45 minutes. In addition to potential time savings gained from the premixed formulation and a more rapid lesion removal, costs savings may also be seen if there are shortened procedural times, which could also positively impact patient sedation time, endoscopy suite utilization, and personnel costs per procedure. Additional studies are being considered to confirm these assumptions.
About the Study
About Eleview™ Important Safety Information WARNINGS AND PRECAUTIONS
CONTRAINDICATIONS ADVERSE REACTIONS
Please see Instructions for Use for complete Important Safety Information.
About Aries Pharmaceuticals, Inc.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170518005430/en/ |