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SAN DIEGO–(BUSINESS WIRE)–Aries 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.

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 mean total injected volume of Eleview needed per procedure for lesion removal was 16.1 mL (range of 3-41 mL) compared to the saline plus methylene blue arm which had a mean total injected volume of 31.6 mL (range of 4-248 mL). In the comparator arm, 49.2% more saline admixture was required than Eleview. Statistical significance (P<0.001) was achieved for this endpoint.
• The mean total injected volume per lesion was also less for Eleview with 0.53 mL per mm of lesion (range of 0.09-1.75 mL/mm) compared to saline admixture which needed a volume of 0.92 mL per mm (range of 0.2-4.96 mL/mm) and represents 42.4% more volume per mm needed of saline admixture than of Eleview. Statistical significance (P<0.001) was also achieved for this endpoint.
• Time to resect the lesion was notably lower for the Eleview arm of the study having a mean time of 19.15 minutes (range of 1-100 minutes) while the comparator arm required 35.5% longer with a mean of 29.7 minutes (range of 2-687 minutes) (p=0.326).

Secondary efficacy endpoints also demonstrated relative improvement for the Eleview arm of the study:

• Injected volume needed to provide initial lift per lesion with Eleview had a mean of 10.4 mL compared to saline plus methylene blue which had a mean of 15.3 mL (p<0.001).
• Less re-injections were necessary when using Eleview (1.05) than the comparator arm (1.79) (p= 0.159).
• When Eleview was used, the lesions were removed in fewer number of pieces (11.9%; p<0.052).
• 58% more en bloc (removal in one piece) resections were possible with Eleview (p<0.125).
• The Sydney Resection Quotient (calculated by dividing the lesion size by the total number of resections (pieces) required to remove the lesion) was 28.8% higher in the Eleview arm (p<0.044).

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
This first-in-human study was a randomized, double blind, multicenter clinical trial with parallel arms with sites in the United States and Europe. 211 patients were included in the primary analysis. The mean lesion size in the Eleview arm was 31.64 mm. In the comparator saline arm, the mean lesion size was 32.31 mm. The data set was presented at Digested Disease Week (DDW) on May 8, 2017 by one of the principal investigators, Dr. Douglas Rex from Indiana University Hospital, Indianapolis, Indiana. Additional principal investigators include: Mike Wallace from Mayo Clinic, Jacksonville, Florida; Prateek Sharma, University of Kansas Medical Center, Kansas City, Kansas; Alessandro Repici, Humanitas Research Hospital, Milan, Italy; and Pradeep Bhandari, Solent Center for Digestive Diseases, Portsmouth, United Kingdom. The clinical trial was sponsored by Cosmo Pharmaceuticals, N.V. (SIX: COPN) (Cosmo), the developer of Eleview.

About Eleview™
Eleview submucosal injectable composition is intended for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device. Developed by Cosmo, Eleview has been 510(k) cleared by the FDA as a class ll medical device and is the only commercially available medical device for this indication. Additional product information at EleviewUS.com. Eleview is available now for order at 888-ARIES-08.

Important Safety Information

WARNINGS AND PRECAUTIONS

• The safety of Eleview has not been established in pregnant or lactating women, or in children under 18 years of age.
• The endoscopist injecting Eleview must be experienced in the injection technique.

CONTRAINDICATIONS
Patients with known sensitivity to any of the components contained in Eleview.

ADVERSE REACTIONS

• Rarely, local bleeding and/or inflammatory reaction could occur which may or may not be associated with Eleview.

Please see Instructions for Use for complete Important Safety Information.

About Aries Pharmaceuticals, Inc.
Aries Pharmaceuticals, Inc. (Aries) is a specialty pharmaceutical company commercializing best-in-class gastroenterology products for the United States market with a focus on products utilized in endoscopy and for the treatment of specific gastrointestinal diseases. The company’s initial portfolio of four products, three of which are still in development, are licensed from Cosmo Pharmaceuticals N.V. to Aries Ltd. Aries is the US distribution arm of Aries Ltd., a wholly owned subsidiary of Cosmo Pharmaceuticals N.V. For further information on Aries, please visit the company’s website: www.aries-pharma.com

Minneapolis, Minnesota (PRWEB) May 18, 2017

FOR IMMEDIATE RELEASE

Editor’s Note: Infographic and Survey Results at Bottom of Release

Contact: Tracy Kurschner
Kurschner Communications
Tracy.kurschner(at)gmail(dot)com
612.309.3957

Show Me the Deal: YA Survey Shows Consumers Flock to Quick-Service Restaurants When there are
Discounts and Offers Involved

–More than Three-Quarters of Respondents Would Go to a Restaurant if it Offered a Discount —
–Mobile Apps Top Choice for Learning About Deals –
— Consumers who are Younger or More Affluent Most Likely to Take Advantage of Apps —
— Largest Percentage of Respondents Take Advantage of App Deals at Least 10 Times/Year –

Minneapolis, May 18, 2017 – A recent study by YA, an industry market leader in delivering high-impact omni-channel marketing promotions for the nation’s most respected brands, shows that discount programs for quick service restaurants (QSRs) are highly effective in changing consumer behavior.

In the March 2017 survey of more than 1,000 U.S. adults, 76 percent said they’d try a QSR they’ve never been to if it offered a discount on their current order, and 69 percent said they’d be likely to try a QSR if they’d get a discount on a future order. In addition, nearly two-thirds (64 percent) said they’d visit a restaurant new to them if they received a “refer a friend” discount.

“In the highly competitive QSR field, restaurants that make discount offers part of their core marketing program are able to increase loyalty and word-of-mouth referrals,” said YA Vice President of Mobile Sales Mark Shelley. “Getting new customers in the door is the first step in creating long-term brand advocates.”

The survey also shows missed opportunity when it comes to mobile applications (Apps) that offer QSR deals. While just over one-quarter (28 percent) of respondents said they had at least one QSR App on their mobile device, nearly half (43 percent) said a QSR App would incent them to visit a restaurant more often. And of those who do have an App, the highest percentage of respondents (31 percent) say they take advantage of offers 10 times or more per year.

Interestingly, when analyzing the demographics of QSR App users, younger consumers and those who have higher household incomes are the heaviest users.

Thirty-Seven percent of respondents who had a household income of between $100,000 and $149,999 have at least one QSR app, and 42 percent of those who make $150,000 or more use a QSR App.

In terms of ages, respondents aged 25-34 have the highest QSR App usage at 37 percent, followed by those aged 18-24 at 30 percent. Only 8 percent of those 65 and older have a QSR App.

The top reason to use a QSR App, according to the study, is to get personalized rewards (29 percent), followed by getting today’s deal (25 percent). For those who are between the ages of 35 and 44, the top reason to use a QSR App is to order food for delivery.

“It’s very common for people in their late 30s and early 40s to have dual incomes and young kids at home, and delivered food is a convenience for which they’re willing to pay,” said Shelley. “As such, marketing promotions programs that segment audiences to cater to their life situations can be very successful.”

The survey also shows affinity for mobile applications, as QSR Apps are the top way respondents say they want to receive information, followed by instant rebates and newspaper coupons.

About the Survey
YA commissioned the survey of more than 1,000 U.S. adults in March 2017.

Survey Responses

1.    How likely would you be to try a QSR you’ve never been to if it offered a discount on your current order?

•     Very likely                     37 percent
•     Somewhat likely                39 percent
•     Neither likely or unlikely        14 percent
•     Somewhat unlikely                 6 percent
•     Not at all likely                 4 percent

2.    How likely would you be to try a QSR you’ve never been to if it offered a discount on a future order?

•     Very likely                     28 percent
•     Somewhat likely                41 percent
•     Neither likely nor unlikely        21 percent
•     Not likely                     6 percent        
•     Not at all likely                     5 percent

3.    How likely would you be to try a QSR you’ve never been to if it offered discounts or free food if you referred a friend?

•     Very likely                      30 percent
•     Somewhat likely                34 percent
•     Neither likely nor unlikely        21 percent
•     Not likely                     8 percent        
•     Not at all likely                 7 percent

4.    To what extent would you agree with the following: “I would participate in a QSR program that allowed me to collect points for free items on future visits” (e.g. Visit us 5 times and your 6th meal is free)

•     Agree strongly                         40 percent
•     Somewhat agree                            38 percent
•     Neither agree nor disagree                14 percent
•     Disagree to some extent                 5 percent
•     Disagree to a great extent                    3 percent

5.    If you are participating in a loyalty program, how many trips would you be willing to make to a QSR before you received your reward (e.g. free sandwich)?

•     Five times                        63 percent
•     6-8 times                         24 percent
•     9-10 times                         10 percent
•     More than 10 times                  3 percent

6.    What would most incent you to refer a friend to a QSR?

•     50% Discount food offer                33 percent
•     Free food Item per referral                30 percent
•     Gift card to restaurant                    37 percent

7.    Do you have a QSR App on your phone?

•     Yes, I have one                        21 percent
•     I have more than one                      7 percent
•     No, I do not                                                    72 percent

8.    If you have a QSR App on your phone, what’s the top reason you have it?

•     To learn about new items                      11 percent
•     To get today’s deals                             25 percent
•     To get personalized rewards                  29 percent
•     To pre-order my food for pickup              22 percent
•     To pre-order my food for delivery             12 percent

9.    If you received offers for deals through the QSR App, how often do you take action on the offer?

•     Never                                      3 percent
•     1-2 times/year                         10 percent
•     3-5 times/year                         23 percent
•     6-10 times/year                             30 percent
•     More than 10 times/year                 31 percent
•     I have not received offers                2 percent

10.    Does a QSR App cause you to visit that restaurant more often?

•     Yes                            43 percent
•     No                            57 percent

11.    How do you prefer to receive updates and offers from a QSR?

•     Newspaper coupons                              15 percent
•     Instant rebates/discounts via text             21 percent
•     An App                                              23 percent
•     Facebook                                         12 percent
•     Online ads                                          9 percent
•     “Deal sites” such as retailmenot.com & slickdeals.com    5 percent
•     I don’t want updates                                 15 percent

12.    How much more likely are you to choose one QSR over another if you have a discount or BOGO or offer?

•     Very likely                                      32 percent
•     Somewhat likely                                  45 percent
•     Would make no difference                 17 percent
•     Somewhat less likely                              3 percent
•     Much less likely                                     3 percent

13.    How likely would you be to visit a QSR that was offering a deal, such as a discount or BOGO, even if it was out of your way?

•     Very likely                                          17 percent
•     Somewhat likely                                      40 percent
•     Would make no difference                 22 percent
•     Somewhat less likely                            16 percent
•     Much less likely                                         5 percent

About YA
For 45 years, YA has been a leader in promotional marketing services. We deliver high-impact, data-driven, digital, social and mobile promotions, such as rebates and rewards, enter to win, referral and loyalty programs, to the nation’s most respected brands. With deep expertise across multiple industries, our end-to-end management of 3,500+ promotions each year creates tens of millions of consumer interactions annually. We then analyze these interactions to understand the drivers of consumer behavior. This makes us experts at turning even first-time customers into loyal brand advocates who take action, buy more and spread the word.