The novel non-DES, non-BMS COBRA PzF NanoCoated Coronary Stent (NCS) with just 14-days DAPT demonstrated statistically less bleeding (BARC 1-5) compared to the DES arm at 3 or 6 months DAPT post-PCI, low 0.6% ST and low 3.7% ischemic-driven TLR at 6 months.
SAN ANTONIO, Oct. 18, 2020 /PRNewswire/ -- CeloNova BioSciences, Inc. (CeloNova), a global medical device company that offers a family of innovative products based upon its proprietary Polyzene™-F nanocoating technology, today announced interim results from the Randomized Trial of COBRA PzF Stenting to REDUCE Duration of Triple Therapy (COBRA-REDUCE), the world's first and only randomized, global 14-day dual antiplatelet therapy (DAPT) study of high bleeding risk patients (HBR), during a late-breaking clinical science session at TCT Connect.
"Today marks a very significant milestone in providing valuable clinical insights into the DAPT duration and stent choice for high bleeding risk patients formally excluded from clinical trials," stated Professor Robert Byrne, MB, BCh, PhD, MRCPI, FESC, Director of Cardiology, Mater Private Hospital, Dublin, Chair of Cardiovascular Research at the Royal College of Surgeons and a Principal Investigator in the COBRA REDUCE trial.
"I would like to thank my colleagues for their outstanding support in successfully completing this portion of the study despite challenges brought on by the COVID-19 world pandemic. We look forward to concluding patient follow-up and secondary analysis at 12 months," said Byrne.
In the COBRA REDUCE trial, 100% of enrolled patients were on oral anticoagulation therapy (OAC) with over 90% of patients presenting with atrial fibrillation. OAC is a major bleeding criterion, per the Academic Research Consortium for High Bleeding Risk (ARC-HBR). Furthermore, close to half of all patients in the study share a second or third major or minor ARC-HBR bleeding criteria, such as recent ischemic stroke, cancer, anemia, or severe or end-stage chronic kidney disease. It was noted that significantly less patients in the COBRA PzF NCS arm received a reduction in OAC intensity compared to the DES arm (COBRA: 46% vs. DES: 56%; p=0.006). Both study arms presented with highly complex lesions and the COBRA PzF NCS arm presented with statistically higher bifurcation rates (COBRA: 20% vs DES: 15%; p=0.034).
The COBRA REDUCE study randomized 996 HBR patients across 59 enrolling global sites to receive either COBRA PzF NCS (n=495) with 14-day DAPT or an FDA-approved DES (n=501) with 3 or 6 months DAPT. COBRA PzF NCS demonstrated the following interim results:
Numerically less bleeding in the co-primary endpoint of BARC class ≥2 bleeding after 14 days (COBRA: 7.5% vs DES: 8.9%; p=0.477) and statistically less bleeding over DES in BARC class 1-5 after randomization (COBRA: 13% vs. DES: 18.3%; p=0.026).
Numerically similar rates in the composite co-primary endpoint of ischemic safety compared to the DES arm (COBRA: 7.7% vs DES: 5.2%; p=0.061). Additional analysis showed statistical non-inferiority when the composite endpoint includes only cardiac-related mortality.
Equal low probable and definite stent thrombosis (0.6%) in both groups (not powered).
Low initial ischemic-driven TLR at 6 months (3.7%).
"We are pleased with COBRA PzF NCS' preliminary performance with just 14-days DAPT in aspects of bleeding and ischemic events," said Carl St. Bernard, President and Chief Executive Officer of CeloNova. "Finding the right DAPT balance is critical to reducing the complexity and complications of long-DAPT regimens following stent placement. The COBRA REDUCE study has advanced our understanding of how to best strike this balance."
"It is encouraging to see that the COBRA stent demonstrated a very low stent thrombosis rate with just 14-days DAPT in this high-risk patient population," said Roxana Mehran, MD, professor of Medicine and Director of Interventional Cardiovascular Research and Clinical Trials at the Zena and Michael A. Wiener Cardiovascular Institute at Icahn School of Medicine at Mount Sinai and a member of the COBRA REDUCE Steering Committee. "We hope to gain further insight into its efficacy with 14-days DAPT in the secondary analysis at 12 months."
COBRA REDUCE's final co-primary endpoint analysis and secondary endpoints, including composite of all-cause death, cardiac death, MI, ischemia-driven TLR, definite and probable stent thrombosis and ischemic stroke at 12-months, are expected to be revealed in Q2 of 2021.
About COBRA PzF NanoCoated Coronary Stent (NCS)
COBRA PzF NCS is the first non drug-eluting, nanocoated coronary stent. COBRA PzF NCS is nanocoated with Polyzene-F, a revolutionary surface coating that acts as a barrier between the device, intimal surface and circulating elements in the blood. It has demonstrated anti-inflammatory and thrombo-resistant properties and significantly faster, higher quality healing compared to market-leading DES in preclinical studies.†1
Over 25,000 patients worldwide have been treated to date with COBRA PzF NCS. The novel stent has been extensively evaluated over the course of 10 years and 10 clinical trials in roughly 3,300 patients worldwide, consistently demonstrating excellent results with low TLR and low ST with short DAPT regimens in a real-world patient population.2
About CeloNova BioSciences, Inc.
CeloNova BioSciences, Inc. is a global medical device company that develops, manufactures and markets a family of products based upon its novel Polyzene-F nanocoating technology. The next generation nanocoating is the result of years of rigorous scientific research and engineering and has been extensively published in numerous academic articles to date. For additional information about CeloNova, please visit our website at www.celonova.com.
The COBRA PzF NanoCoated Coronary Stent System is indicated for improving coronary luminal diameter in patients, including patients with diabetes mellitus, with symptomatic ischemic heart disease due to de novo lesions in native coronary arteries. The COBRA PzF NanoCoated stent is intended for use in patients eligible for percutaneous transluminal coronary angioplasty (PTCA) with reference vessel diameter (RVD) of 2.5-4.0mm and lesion length of ≤24mm. Click here for IMPORTANT SAFETY INFORMATION. Rx only.
The COBRA PzF NanoCoated Coronary Stent is not currently approved or indicated for high bleeding risk patients with 14-day DAPT.
*myocardial infarction, definite and probable stent thrombosis, or ischemic stroke† AS DEMONSTRATED IN PRECLINICAL STUDIES. Correlation between bench testing, animal studies and humans have not been determined.
1. Jinnouchi H Mori H, et al. Thromboresistance and Functional Healing in the COBRA PzF Stent versus Competitor DES: Implications for Dual Anti-Platelet Therapy. EuroIntervention. 2019 July 20;15(4):e342-e353. 2. ATLANTA FIM (n=55) TLR 3.6%, LST 0%; ATLANTA 2 Registry (n=300) TLR 6.5%, LST 0%; REVEAL OCT (n=34) Strut Coverage: PzF-97%, DES-90%, BMS-96%; ATLANTA FME Registry (n=500) TLR 4.3%, LST 0%; MAILLARD IIT (n=100) TLR 5%, ST 0%; UMEÅ IIT (n=103) TLR 3.9%, ST 0%.
Photo - https://mma.prnewswire.com/media/1174659/COBRA_PzF_NanoCoated_Coronary_Stent.jpg
(RTTNews) - The Taiwan stock market has moved higher in two straight sessions, collecting more than 50 points or 0.4 percent along the way. The Taiwan Stock Exchange now rests just above the 12,915-point plateau and it's tipped to open in the green again on Friday.
The global forecast for the Asian markets is cautiously optimistic on hopes for a stimulus bill in the United States. The European markets were mixed and flat and the U.S. markets were up and the Asian markets figure to split the difference.
The TSE finished modestly higher on Thursday following gains from the financial shares, technology stocks and cement companies.
For the day, the index gained 39.78 points or 0.31 percent to finish at the daily high of 12,917.03 after moving as low as 12,827.40.
Among the actives, Cathay Financial rose 0.26 percent, while Mega Financial collected 0.54 percent, CTBC Financial jumped 1.39 percent, Fubon Financial was up 0.24 percent, First Financial advanced 0.99 percent, E Sun Financial gathered 1.22 percent, Taiwan Semiconductor Manufacturing Company added 0.44 percent, United Microelectronics Corporation surged 5.26 percent, Hon Hai Precision gained 0.50 percent, Largan Precision eased 0.16 percent, Catcher Technology rallied 2.54 percent, MediaTek shed 0.43 percent, Formosa Plastic climbed 1.01 percent, Asia Cement perked 1.10 percent and Taiwan Cement spiked 1.74 percent.
The lead from Wall Street is mildly positive as stocks fluctuated on Thursday, bouncing back and forth across the unchanged line before finishing slightly higher.
The Dow added 152.84 points or 0.54 percent to finish at 28,363.66, while the NASDAQ gained 21.31 points or 0.19 percent to end at 11,506.01 and the S&P 500 rose 17.93 points or 0.52 percent to close at 3,453.49.
The strength on Wall Street came as House Speaker Nancy Pelosi indicated Democrats and the White House continue to make progress toward an agreement on a new stimulus bill.
In economic news, the Labor Department said initial jobless claims came in below estimates last week. Also, the National Association of Realtors reported that existing home sales spiked by more than anticipated in September.
Crude oil prices moved higher Thursday, cutting into losses in the previous session after reports that Russian President Vladimir Putin said his country has not ruled out delaying OPEC+ production increases that are set for January. West Texas Intermediate Crude oil futures for December ended up $0.63 or 1.4 percent at $40.64 a barrel.
Closer to home, Taiwan will provide September figures for industrial production and retail sales later today; in August, industrial production was up 4.7 percent on year and retail sales climbed 8.17 percent.
The wait is over! The first Mando Monday is here and it’s just the beginning. Star Wars fans across the globe tuned into a special Star Wars "Mando Mondays” digital event this morning where talent from "The Mandalorian,” including Pedro Pascal, Carl Weathers and Giancarlo Esposito, revealed the latest and greatest products and digital content inspired by the Emmy award-winning series. Mando Mondays is an all-new global consumer products, games and publishing program that will debut new goods inspired by the Disney+ program every Monday from now until December 21.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201026005293/en/
Mando Mondays Logo (Graphic: Business Wire)
This morning’s global digital launch provided fans with a first look at multiple new items set to bring characters and moments from "The Mandalorian” to life in fresh and creative ways. Some of the items featured will go on sale or pre-order today at 1 p.m. PT / 4 p.m. ET across top retailers globally, including shopDisney.com.
Products available for pre-order include the Star Wars Retro Collection from Hasbro, the The Child Real Moves Plush from Mattel, a Mandalorian Flying with Blaster bobblehead from Funko and The Art of Star Wars: The Mandalorian from ABRAMS. Plus, today a new line of skateboards, accessories and apparel inspired by "The Mandalorian” are available now from Element. And starting this week, new themed content is coming to multiple Star Wars games such as the recently launched Star Wars: Squadrons from Motive.
"Today’s global digital event celebrates the first of many Mando Mondays to come,” said Paul Southern, Senior Vice President, Licensing and Franchise, Lucasfilm. "Over the course of the next eight weeks, we look forward to unveiling the widest assortment yet of highly anticipated products and digital content inspired by beloved characters and moments from The Mandalorian.”
Fans can check out the full list of products revealed on MandoMondays.com and catch a replay of today’s event on Star Wars YouTube.
Stay tuned to MandoMondays.com each Monday through December 21 for the latest new reveals, interviews, videos and more and join the conversation via social media with #MandoMondays.
The Mandalorian and the Child continue their journey this Friday, October 30 in the highly anticipated second season of "The Mandalorian”, streaming only on Disney+.
About Disney Consumer Products, Games and Publishing
Disney Consumer Products, Games and Publishing (CPGP) brings the magic of The Walt Disney Company’s brands and franchises—including Disney, Pixar, Marvel, Star Wars, National Geographic, and more—into the daily lives of families and fans around the world through products and experiences across more than 100 retail categories from toys and t-shirts to apps, books, video games, and more. A division of the Disney Parks, Experiences and Products segment, CPGP’s global operations include: the world’s largest licensing business, one of the biggest children’s publishing brands, a leading licensor of interactive games across platforms, Disney store locations globally, and the shopDisney e-commerce platform.
About Lucasfilm Ltd.
Lucasfilm Ltd., a wholly-owned subsidiary of The Walt Disney Company, is a global leader in film, television and digital entertainment. In addition to its feature film and series production, the company's offerings include cutting-edge visual effects and audio post-production, digital animation, immersive storytelling, and the management of the global merchandising activities for its entertainment properties including the legendary STAR WARS and INDIANA JONES franchises. Lucasfilm Ltd. is headquartered in northern California.
Lucasfilm, the Lucasfilm logo, STAR WARS and related properties are trademarks and/or copyrights, in the United States and other countries, of Lucasfilm Ltd. and/or its affiliates. © & TM Lucasfilm Ltd.
Disney+ is the dedicated streaming home for movies and shows from Disney, Pixar, Marvel, Star Wars, National Geographic, and more. As part of Disney’s Direct-to-Consumer and International (DTCI) segment, Disney+ is available on most internet-connected devices and offers commercial-free programming with a variety of original feature-length films, documentaries, live-action and animated series and short-form content. Alongside unprecedented access to Disney’s incredible library of film and television entertainment, the service is also the exclusive streaming home for the latest releases from The Walt Disney Studios. Disney+ is available as part of a bundle offer that gives subscribers access to Disney+, Hulu (ad-supported), and ESPN+. Visit DisneyPlus.com to subscribe and/or learn more about the service.
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