|By PR Newswire||
|September 2, 2014 07:00 AM EDT||
CARLSBAD, Calif., Sept. 2, 2014 /PRNewswire/ -- Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today that data from three drugs in its lipid franchise were highlighted in four presentations at the 2014 European Society of Cardiology (ESC) Congress in Barcelona Spain. Isis has created a lipid franchise of antisense drugs designed to provide effective and safe therapeutic options to treat patients with lipid disorders. This franchise is composed of one commercialized drug and several other drugs in clinical development designed to treat cardiovascular conditions by reducing specific lipid parameters that are risk factors for cardiovascular disease. Data presented include:
- A retrospective analysis of data from a long-term extension study of KYNAMRO® (mipomersen sodium) injection. In this analysis patients with heterozygous familial hypercholesterolemia (HeFH) and homozygous familial hypercholesterolemia (HoFH) treated for one year with KYNAMRO experienced a reduction in Major Adverse Cardiovascular Events (MACE) from 25.72/1000 months (in the two years prior to KYNAMRO® treatments) to 4.85/1000 months.
- An overall summary of the Phase 2 program for ISIS-APOCIIIRx in which treatment with ISIS-APOCIIIRx produced consistent, robust and statistically significant reductions in triglycerides, apoC-III and non-HDL and increases in HDL-cholesterol in all patient populations evaluated.
- Data from the Phase 1 study of ISIS-APO(a)Rx in which treatment with ISIS-APO(a)Rx produced dose-dependent and significant reductions in Lp(a) levels in healthy volunteers.
In two invited presentations, Dr. John Kastelein, M.D., Ph.D., professor of medicine, chairman of the department of vascular medicine, Academic Medical Center, University of Amsterdam, presented data from a retrospective analysis of 104 patients who enrolled in the long-term extension study of KYNAMRO after having completed one of the KYNAMRO Phase 3 studies in patients with FH. All patients who completed at least one year of treatment with KYNAMRO were included in the analysis. In this retrospective analysis, the rate of MACE in patients treated with KYNAMRO for one year were adjudicated by an independent committee and compared to the rate of MACE in the same patients based on their medical history prior to treatment with KYNAMRO. During the one year of treatment with KYNAMRO, the patients had a rate of MACE of 4.85/1000 months compared to a rate of MACE of 25.72/1000 months for the same patients in the two years prior to treatment (p < 0.0001). The rate of MACE was defined in this analysis as myocardial infarction, stroke, unstable angina and revascularization procedures.
"The statistical significant decrease in rate of MACE in patients treated with KYNAMRO represents an important finding and complements the therapeutic profile of KYNAMRO," said Dr. Kastelein. "These results are encouraging and support the potential for therapeutic benefit in patients with homozygous FH, the most aggressive form of familial hypercholesterolemia."
In one of the invited presentations, Dr. Kastelein also provided an overview of the results from the Phase 2 program for ISIS-APOCIIIRx, a novel triglyceride-lowering drug. Isis is currently evaluating ISIS-APOCIIIRx in a Phase 3 study in patients with familial chylomicronemia syndrome (FCS) and plans to initiate additional Phase 3 studies in patients with severely elevated triglycerides, including patients with triglyceride levels greater than 880 mg/dL. In the Phase 2 program, in all patient groups studied, irrespective of their incoming triglyceride levels, treatment with ISIS-APOCIIIRx consistently reduced apoC-III by up to 88 percent, triglycerides by up to 71 percent, and increased HDL-cholesterol by up to 78 percent, with a positive effect on non-HDL. In all of the clinical studies, ISIS-APOCIIIRx had a tolerability profile supportive of continued development. In addition, the final data analysis from the Phase 2 study evaluating ISIS-APOCIIIRx as a single agent in patients with very high to severely high triglycerides was presented by Dr. Vickie Alexander, Ph.D., director of clinical development at Isis, in a poster as part of the lipoproteins in cardiovascular prevention session on Sunday, August 31 at the ESC Congress.
In a separate presentation, Dr. Sotirios Tsimikas, M.D., professor of medicine and director of vascular medicine at the University of California, San Diego and vice president of clinical development and leader of the cardiovascular franchise at Isis, presented data from the Phase 1 study of ISIS-APO(a)Rx in healthy volunteers with baseline elevated Lp(a) levels. In this study, treatment with ISIS-APO(a)Rx produced dose-dependent reductions of up to 89 percent in lipoprotein(a) or Lp(a), an independent risk factor for coronary artery disease. In addition to Lp(a) activity, subjects treated with 300 mg/week of ISIS-APO(a)Rx also experienced an up to 90 percent reduction in oxidized phospholipids, lipids that play an important role in proinflammatory and proatherogenic processes believed to be associated with Lp(a). The tolerability profile for ISIS-APO(a)Rx in this study supported further development and Isis is currently evaluating ISIS-APO(a)Rx in a Phase 2 study in patients with elevated Lp(a) levels.
ABOUT ISIS PHARMACEUTICALS, INC.
Isis is exploiting its leadership position in antisense technology to discover and develop novel drugs for its product pipeline and for its partners. Isis' broad pipeline consists of 32 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic, severe and rare diseases, including neurological disorders, and cancer. Isis' partner, Genzyme, is commercializing Isis' lead product, KYNAMRO®, in the United States and other countries for the treatment of patients with homozygous FH. Isis' patents provide strong and extensive protection for its drugs and technology. Additional information about Isis is available at www.isispharm.com.
ISIS PHARMACEUTICALS' FORWARD-LOOKING STATEMENT
This press release includes forward-looking statements regarding the development, activity, therapeutic benefit, safety and commercial potential of KYNAMRO in treating patients with homozygous FH and the discovery, development, activity, therapeutic potential and safety of ISIS-APOCIIIRx and ISIS-APO(a)Rx. Any statement describing Isis' goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. Isis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements. Although Isis' forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Isis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Isis' programs are described in additional detail in Isis' annual report on Form 10-K for the year ended December 31, 2013, and its most recent quarterly report on Form 10-Q, which are on file with the SEC. Copies of these and other documents are available from the Company.
In this press release, unless the context requires otherwise, "Isis," "Company," "we," "our," and "us" refers to Isis Pharmaceuticals and its subsidiaries.
Isis Pharmaceuticals® is a registered trademark of Isis Pharmaceuticals, Inc. KYNAMRO® is a registered trademark of Genzyme Corporation.
SOURCE Isis Pharmaceuticals, Inc.
Electric power utilities face relentless pressure on their financial performance, and reducing distribution grid losses is one of the last untapped opportunities to meet their business goals. Combining IoT-enabled sensors and cloud-based data analytics, utilities now are able to find, quantify and reduce losses faster – and with a smaller IT footprint. Solutions exist using Internet-enabled sensors deployed temporarily at strategic locations within the distribution grid to measure actual line lo...
Oct. 9, 2015 06:30 PM EDT
Containers have changed the mind of IT in DevOps. They enable developers to work with dev, test, stage and production environments identically. Containers provide the right abstraction for microservices and many cloud platforms have integrated them into deployment pipelines. DevOps and Containers together help companies to achieve their business goals faster and more effectively.
Oct. 9, 2015 06:15 PM EDT Reads: 184
The buzz continues for cloud, data analytics and the Internet of Things (IoT) and their collective impact across all industries. But a new conversation is emerging - how do companies use industry disruption and technology enablers to lead in markets undergoing change, uncertainty and ambiguity? Organizations of all sizes need to evolve and transform, often under massive pressure, as industry lines blur and merge and traditional business models are assaulted and turned upside down. In this new da...
Oct. 9, 2015 06:00 PM EDT Reads: 304
Cloud computing delivers on-demand resources that provide businesses with flexibility and cost-savings. The challenge in moving workloads to the cloud has been the cost and complexity of ensuring the initial and ongoing security and regulatory (PCI, HIPAA, FFIEC) compliance across private and public clouds. Manual security compliance is slow, prone to human error, and represents over 50% of the cost of managing cloud applications. Determining how to automate cloud security compliance is critical...
Oct. 9, 2015 06:00 PM EDT Reads: 317
The Internet of Everything is re-shaping technology trends–moving away from “request/response” architecture to an “always-on” Streaming Web where data is in constant motion and secure, reliable communication is an absolute necessity. As more and more THINGS go online, the challenges that developers will need to address will only increase exponentially. In his session at @ThingsExpo, Todd Greene, Founder & CEO of PubNub, will explore the current state of IoT connectivity and review key trends an...
Oct. 9, 2015 05:30 PM EDT
There are many considerations when moving applications from on-premise to cloud. It is critical to understand the benefits and also challenges of this migration. A successful migration will result in lower Total Cost of Ownership, yet offer the same or higher level of robustness. Migration to cloud shifts computing resources from your data center, which can yield significant advantages provided that the cloud vendor an offer enterprise-grade quality for your application.
Oct. 9, 2015 05:30 PM EDT Reads: 299
Today air travel is a minefield of delays, hassles and customer disappointment. Airlines struggle to revitalize the experience. GE and M2Mi will demonstrate practical examples of how IoT solutions are helping airlines bring back personalization, reduce trip time and improve reliability. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Dr. Sarah Cooper, M2Mi's VP Business Development and Engineering, will explore the IoT cloud-based platform technologies driv...
Oct. 9, 2015 05:15 PM EDT Reads: 117
Achim Weiss is Chief Executive Officer and co-founder of ProfitBricks. In 1995, he broke off his studies to co-found the web hosting company "Schlund+Partner." The company "Schlund+Partner" later became the 1&1 web hosting product line. From 1995 to 2008, he was the technical director for several important projects: the largest web hosting platform in the world, the second largest DSL platform, a video on-demand delivery network, the largest eMail backend in Europe, and a universal billing syste...
Oct. 9, 2015 04:45 PM EDT Reads: 202
The web app is agile. The REST API is agile. The testing and planning are agile. But alas, data infrastructures certainly are not. Once an application matures, changing the shape or indexing scheme of data often forces at best a top down planning exercise and at worst includes schema changes that force downtime. The time has come for a new approach that fundamentally advances the agility of distributed data infrastructures. Come learn about a new solution to the problems faced by software organ...
Oct. 9, 2015 04:00 PM EDT Reads: 908
Chris Van Tuin, Chief Technologist for the Western US at Red Hat, has over 20 years of experience in IT and Software. Since joining Red Hat in 2005, he has been architecting solutions for strategic customers and partners with a focus on emerging technologies including IaaS, PaaS, and DevOps. He started his career at Intel in IT and Managed Hosting followed by leadership roles in services and sales engineering at Loudcloud and Linux startups.
Oct. 9, 2015 04:00 PM EDT Reads: 225
The Internet of Things (IoT) is growing rapidly by extending current technologies, products and networks. By 2020, Cisco estimates there will be 50 billion connected devices. Gartner has forecast revenues of over $300 billion, just to IoT suppliers. Now is the time to figure out how you’ll make money – not just create innovative products. With hundreds of new products and companies jumping into the IoT fray every month, there’s no shortage of innovation. Despite this, McKinsey/VisionMobile data...
Oct. 9, 2015 04:00 PM EDT Reads: 239
You have your devices and your data, but what about the rest of your Internet of Things story? Two popular classes of technologies that nicely handle the Big Data analytics for Internet of Things are Apache Hadoop and NoSQL. Hadoop is designed for parallelizing analytical work across many servers and is ideal for the massive data volumes you create with IoT devices. NoSQL databases such as Apache HBase are ideal for storing and retrieving IoT data as “time series data.”
Oct. 9, 2015 03:45 PM EDT Reads: 508
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome,” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.
Oct. 9, 2015 03:45 PM EDT Reads: 142
As a CIO, are your direct reports IT managers or are they IT leaders? The hard truth is that many IT managers have risen through the ranks based on their technical skills, not their leadership ability. Many are unable to effectively engage and inspire, creating forward momentum in the direction of desired change. Renowned for its approach to leadership and emphasis on their people, organizations increasingly look to our military for insight into these challenges.
Oct. 9, 2015 03:15 PM EDT Reads: 158
In recent years, at least 40% of companies using cloud applications have experienced data loss. One of the best prevention against cloud data loss is backing up your cloud data. In his General Session at 17th Cloud Expo, Bryan Forrester, Senior Vice President of Sales at eFolder, will present how organizations can use eFolder Cloudfinder to automate backups of cloud application data. He will also demonstrate how easy it is to search and restore cloud application data using Cloudfinder.
Oct. 9, 2015 03:00 PM EDT Reads: 498