|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.
SYS-CON Events announced today that Intelligent Systems Services will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Established in 1994, Intelligent Systems Services Inc. is located near Washington, DC, with representatives and partners nationwide. ISS’s well-established track record is based on the continuous pursuit of excellence in designing, implementing and supporting nationwide clients’ mission-cri...
Apr. 27, 2015 02:15 AM EDT Reads: 2,819
SYS-CON Events announced today that B2Cloud, a provider of enterprise resource planning software, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. B2cloud develops the software you need. They have the ideal tools to help you work with your clients. B2Cloud’s main solutions include AGIS – ERP, CLOHC, AGIS – Invoice, and IZUM
Apr. 27, 2015 02:00 AM EDT Reads: 3,587
SYS-CON Events announced today that Tufin, the market-leading provider of Security Policy Orchestration Solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. As the market leader of Security Policy Orchestration, Tufin automates and accelerates network configuration changes while maintaining security and compliance. Tufin's award-winning Orchestration Suite™ gives IT organizations the power and a...
Apr. 27, 2015 01:45 AM EDT Reads: 3,625
SYS-CON Events announced today that Cloudian, Inc., the leading provider of hybrid cloud storage solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Cloudian, Inc., is a Foster City, California - based software company specializing in cloud storage software. The main product is Cloudian, an Amazon S3-compliant cloud object storage platform, the bedrock of cloud computing systems, that enables c...
Apr. 27, 2015 01:00 AM EDT Reads: 2,756
SYS-CON Events announced today that Gridstore™, the leader in hyper-converged infrastructure purpose-built to optimize Microsoft workloads, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Gridstore™ is the leader in hyper-converged infrastructure purpose-built for Microsoft workloads and designed to accelerate applications in virtualized environments. Gridstore’s hyper-converged infrastructure is the ...
Apr. 27, 2015 12:45 AM EDT Reads: 4,665
Temasys has announced senior management additions to its team. Joining are David Holloway as Vice President of Commercial and Nadine Yap as Vice President of Product. Over the past 12 months Temasys has doubled in size as it adds new customers and expands the development of its Skylink platform. Skylink leads the charge to move WebRTC, traditionally seen as a desktop, browser based technology, to become a ubiquitous web communications technology on web and mobile, as well as Internet of Things...
Apr. 27, 2015 12:45 AM EDT Reads: 2,334
“With easy-to-use SDKs for Atmel’s platforms, IoT developers can now reap the benefits of realtime communication, and bypass the security pitfalls and configuration complexities that put IoT deployments at risk,” said Todd Greene, founder & CEO of PubNub. PubNub will team with Atmel at CES 2015 to launch full SDK support for Atmel’s MCU, MPU, and Wireless SoC platforms. Atmel developers now have access to PubNub’s secure Publish/Subscribe messaging with guaranteed ¼ second latencies across PubN...
Apr. 27, 2015 12:00 AM EDT Reads: 3,883
SYS-CON Events announced today that IDenticard will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. IDenticard™ is the security division of Brady Corp (NYSE: BRC), a $1.5 billion manufacturer of identification products. We have small-company values with the strength and stability of a major corporation. IDenticard offers local sales, support and service to our customers across the United States and Canada...
Apr. 27, 2015 12:00 AM EDT Reads: 5,277
SYS-CON Events announced today that On the Avenue Marketing Group, a sales and marketing firm that utilizes events to market and sell products to consumers, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. On the Avenue Marketing Group (OTA) is a sales and marketing firm that utilizes events to market and sell products to consumers. On behalf of our clients, we attend thousands of fairs, festivals, exp...
Apr. 26, 2015 07:30 PM EDT Reads: 3,507
Containers and microservices have become topics of intense interest throughout the cloud developer and enterprise IT communities. Accordingly, attendees at the upcoming 16th Cloud Expo at the Javits Center in New York June 9-11 will find fresh new content in a new track called PaaS | Containers & Microservices Containers are not being considered for the first time by the cloud community, but a current era of re-consideration has pushed them to the top of the cloud agenda. With the launch ...
Apr. 26, 2015 07:00 PM EDT Reads: 2,892
While DevOps most critically and famously fosters collaboration, communication, and integration through cultural change, culture is more of an output than an input. In order to actively drive cultural evolution, organizations must make substantial organizational and process changes, and adopt new technologies, to encourage a DevOps culture. Moderated by Andi Mann, panelists will discuss how to balance these three pillars of DevOps, where to focus attention (and resources), where organizations m...
Apr. 26, 2015 05:15 PM EDT Reads: 2,051
“In the past year we've seen a lot of stabilization of WebRTC. You can now use it in production with a far greater degree of certainty. A lot of the real developments in the past year have been in things like the data channel, which will enable a whole new type of application," explained Peter Dunkley, Technical Director at Acision, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Apr. 26, 2015 05:00 PM EDT Reads: 4,492
of cloud, colocation, managed services and disaster recovery solutions, will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. TierPoint, LLC, is a leading national provider of information technology and data center services, including cloud, colocation, disaster recovery and managed IT services, with corporate headquarters in St. Louis, MO. TierPoint was formed through the strategic combination of some of t...
Apr. 26, 2015 04:30 PM EDT Reads: 1,667
SYS-CON Events announced today that Column Technologies, a global technology solutions company, will exhibit at SYS-CON's DevOps Summit 2015 New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. Established in 1998, Column Technologies is a leader in application performance and infrastructure management for commercial and federal markets. The company is headquartered in the United States, with a diverse and talented team of more than 350 employees around th...
Apr. 26, 2015 04:00 PM EDT Reads: 1,807
Health care systems across the globe are under enormous strain, as facilities reach capacity and costs continue to rise. M2M and the Internet of Things have the potential to transform the industry through connected health solutions that can make care more efficient while reducing costs. In fact, Vodafone's annual M2M Barometer Report forecasts M2M applications rising to 57 percent in health care and life sciences by 2016. Lively is one of Vodafone's health care partners, whose solutions enable o...
Apr. 26, 2015 03:00 PM EDT Reads: 1,535