|By Marketwired .||
|January 3, 2013 03:31 PM EST||
CAMBRIDGE, MA -- (Marketwire) -- 01/03/13 -- Radius Health, Inc. ("Radius"), a biopharmaceutical company focused on developing new therapeutics for the treatment of osteoporosis and other women's health conditions, completed enrollment for its randomized Phase 2 study of BA058-transdermal (BA058-TD) in healthy postmenopausal women with osteoporosis. The last of 250 patients completed her randomization visit for the Phase 2 study of this short wear-time transdermal patch based on 3M's patented Microstructured Transdermal System technology to administer BA058 without the need for subcutaneous injection.
Radius, which launched its new website this month at www.radiuspharm.com, is developing BA058, a novel synthetic peptide analog of human Parathyroid Hormone related Protein ("hPTHrP") that is a bone anabolic compound with the potential to treat severe osteoporosis. Currently, BA058 is also being studied as a daily subcutaneous injection (BA058-SC) in a Phase 3 study with 2,400 patients for fracture prevention in women with severe postmenopausal osteoporosis, in addition to the Phase 2 study of the transdermal patch, which is designed to improve patient compliance. Radius and 3M Drug Delivery Systems announced in December 2012 an exclusive agreement for the development and commercialization of the BA058-TD short wear time patch.
"With both studies underway, we are excited about the opportunity to improve treatment for patients with osteoporosis, a dramatically underserved patient population," said Michael Wyzga, Radius president and chief executive officer. "Our Phase 2 data for the BA058-SC demonstrates strong clinical evidence of bone-building capability, and with enrollment now complete in the Phase 2 transdermal patch trial, we seek to translate these results into a next generation, short wear time patch, which we hope will improve the therapeutic experience and compliance for patients with postmenopausal osteoporosis."
The Phase 2 BA058-transdermal study is a randomized, double-blind, placebo-controlled trial, designed to evaluate the safety and efficacy of BA058-TD in otherwise healthy postmenopausal women with osteoporosis, as assessed by changes in bone mineral density (BMD). In addition, pharmacokinetic parameters and serum markers of bone metabolism for BA058-TD will be compared to both transdermal placebo and BA058-SC.
"Phase 1 study data for BA058-TD showed that a five-minute patch wear time delivers peak drug levels consistent with subcutaneous injection," said Dr. Michael Bolognese, of Bethesda Health Research in Maryland and an investigator in the study. "We look forward to studying this potentially innovative treatment that has the potential to provide patients with an effective bone-building alternative to a daily subcutaneous injection. Our hope is patient compliance could increase with this novel mode of drug delivery."
Radius previously announced positive results from a series of BA058-TD Phase 1 clinical trials which successfully demonstrated the ability of the transdermal patch to safely and rapidly deliver BA058 after a short wear time, with no increased delivery resulting from longer wear, as well as supportive biochemical evidence of bone-building activity following seven days of dosing.
The previous Phase 1 pharmacokinetic studies have provided a strong basis for the current Phase 2 BA058-TD trial with key findings to date including:
Key findings from the PK study include:
- Rapid release of BA058 from the transdermal patch
- Peak transdermal drug levels consistent with BA058 subcutaneous injection
- Faster time to reach peak concentration as well as more rapid elimination compared to subcutaneous injection
- Increase in the serum bone-formation marker P1NP in serum after seven days of exposure, consistent with bone-building activity
- Identification of an optimal wear time of 5 minutes or less, as well as effective sites of application
Additional study details can be found at www.clinicaltrials.gov.
Radius Health's new website at www.radiuspharm.com was developed by LaVoie Group Strategic Communications. The site features details on the disease areas Radius focuses on, including osteoporosis and menopause, as well as information on Radius' development pipeline.
About Radius Health
Radius is a biopharmaceutical company focused on developing new therapeutics for the treatment of osteoporosis and other women's health conditions. Radius is committed to the development of advanced therapeutics for the large and underserved osteoporosis market. The Company's lead product candidate, BA058-SC, is in development to reduce the risk of complications associated with osteoporosis, such as fracture. The Company also has a next-generation transdermal patch, BA058-TD, being developed as a short wear-time delivery vehicle intended to improve patient compliance with convenience and ease of use, as well as a product in development to treat symptoms associated with menopause. Learn more by visiting the company's new website at www.RadiusPharm.com
About 3M Drug Delivery Systems
3M Drug Delivery Systems partners with pharmaceutical and biotech companies to develop pharmaceuticals using 3M's inhalation or transdermal drug delivery technology including microneedles. 3M offers a full range of feasibility, development and manufacturing capabilities combined with regulatory guidance to help bring products to market. In-house resources, including toxicology, regulatory expertise, quality assurance, operations, and marketed product support, are available for each step of the development and commercialization process. This depth of resources is one reason why more than 50 percent of all metered-dose inhalers worldwide and 60 percent of all transdermal systems in the United States utilize 3M drug delivery technology. For more information, please visit www.3M.com/dds or call 1-800-643-8086.
3M captures the spark of new ideas and transforms them into thousands of ingenious products. Our culture of creative collaboration inspires a never-ending stream of powerful technologies that make life better. 3M is the innovation company that never stops inventing. With $30 billion in sales, 3M employs about 84,000 people worldwide and has operations in more than 65 countries. For more information, visit www.3M.com or follow @3MNews on Twitter.
3M is a trademark of 3M Company.
Safe Harbor for Forward-Looking Statements
Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the development of Radius' products, the size of the osteoporosis market or the prospects for BA-058SC and BA-058TD, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Radius or its management, may identify forward-looking statements. Radius cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by Radius to secure and maintain relationships with collaborators; risks relating to clinical trials; risks relating to the commercialization, if any, of Radius' proposed product candidates (such as marketing, regulatory, patent, product liability, supply, competition, and other risks); dependence on the efforts of third parties; dependence on intellectual property; and risks that Radius may lack the financial resources and access to capital to fund our operations. Further information on the factors and risks that could affect Radius' business, financial conditions and results of operations are contained in Radius' filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov. The forward-looking statements represent Radius' estimate as of the date hereof only, and Radius specifically disclaims any duty or obligation to update forward-looking statements.
Wearable technology was dominant at this year’s International Consumer Electronics Show (CES) , and MWC was no exception to this trend. New versions of favorites, such as the Samsung Gear (three new products were released: the Gear 2, the Gear 2 Neo and the Gear Fit), shared the limelight with new wearables like Pebble Time Steel (the new premium version of the company’s previously released smartwatch) and the LG Watch Urbane. The most dramatic difference at MWC was an emphasis on presenting wearables as fashion accessories and moving away from the original clunky technology associated with t...
Mar. 31, 2015 10:00 PM EDT Reads: 1,597
SYS-CON Events announced today that robomq.io will exhibit at SYS-CON's @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. robomq.io is an interoperable and composable platform that connects any device to any application. It helps systems integrators and the solution providers build new and innovative products and service for industries requiring monitoring or intelligence from devices and sensors.
Mar. 31, 2015 06:00 PM EDT Reads: 1,602
Internet of Things (IoT) will be a hybrid ecosystem of diverse devices and sensors collaborating with operational and enterprise systems to create the next big application. In their session at @ThingsExpo, Bramh Gupta, founder and CEO of robomq.io, and Fred Yatzeck, principal architect leading product development at robomq.io, will discuss how choosing the right middleware and integration strategy from the get-go will enable IoT solution developers to adapt and grow with the industry, while at the same time reduce Time to Market (TTM) by using plug and play capabilities offered by a robust I...
Mar. 31, 2015 04:00 PM EDT Reads: 614
After making a doctor’s appointment via your mobile device, you receive a calendar invite. The day of your appointment, you get a reminder with the doctor’s location and contact information. As you enter the doctor’s exam room, the medical team is equipped with the latest tablet containing your medical history – he or she makes real time updates to your medical file. At the end of your visit, you receive an electronic prescription to your preferred pharmacy and can schedule your next appointment.
Mar. 31, 2015 03:45 PM EDT Reads: 1,022
SYS-CON Events announced today that Solgenia 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, and the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Solgenia is the global market leader in Cloud Collaboration and Cloud Infrastructure software solutions. Designed to “Bridge the Gap” between Personal and Professional Social, Mobile and Cloud user experiences, our solutions help large and medium-sized organizations dr...
Mar. 31, 2015 03:00 PM EDT Reads: 3,049
While not quite mainstream yet, WebRTC is starting to gain ground with Carriers, Enterprises and Independent Software Vendors (ISV’s) alike. WebRTC makes it easy for developers to add audio and video communications into their applications by using Web browsers as their platform. But like any market, every customer engagement has unique requirements, as well as constraints. And of course, one size does not fit all. In her session at WebRTC Summit, Dr. Natasha Tamaskar, Vice President, Head of Cloud and Mobile Strategy at GENBAND, will explore what is needed to take a real time communications ...
Mar. 31, 2015 02:39 PM EDT Reads: 560
SYS-CON Events announced today that Litmus Automation 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. Litmus Automation’s vision is to provide a solution for companies that are in a rush to embrace the disruptive Internet of Things technology and leverage it for real business challenges. Litmus Automation simplifies the complexity of connected devices applications with Loop, a secure and scalable cloud platform.
Mar. 31, 2015 12:00 PM EDT Reads: 656
The world's leading Cloud event, Cloud Expo has launched Microservices Journal on the SYS-CON.com portal, featuring over 19,000 original articles, news stories, features, and blog entries. DevOps Journal is focused on this critical enterprise IT topic in the world of cloud computing. Microservices Journal offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. Follow new article posts on Twitter at @MicroservicesE
Mar. 31, 2015 12:00 PM EDT Reads: 1,574
SYS-CON Events announced today the IoT Bootcamp – Jumpstart Your IoT Strategy, being held June 9–10, 2015, in conjunction with 16th Cloud Expo and Internet of @ThingsExpo at the Javits Center in New York City. This is your chance to jumpstart your IoT strategy. Combined with real-world scenarios and use cases, the IoT Bootcamp is not just based on presentations but includes hands-on demos and walkthroughs. We will introduce you to a variety of Do-It-Yourself IoT platforms including Arduino, Raspberry Pi, BeagleBone, Spark and Intel Edison. You will also get an overview of cloud technologies s...
Mar. 31, 2015 11:00 AM EDT Reads: 2,251
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 of Docker's initial release in March of 2013, interest was revved up several notches. Then late last...
Mar. 31, 2015 09:15 AM EDT Reads: 2,305
The WebRTC Summit 2015 New York, to be held June 9-11, 2015, at the Javits Center in New York, NY, announces that its Call for Papers is open. Topics include all aspects of improving IT delivery by eliminating waste through automated business models leveraging cloud technologies. WebRTC Summit is co-located with 16th International Cloud Expo, @ThingsExpo, Big Data Expo, and DevOps Summit.
Mar. 31, 2015 09:00 AM EDT Reads: 1,732
SOA Software has changed its name to Akana. With roots in Web Services and SOA Governance, Akana has established itself as a leader in API Management and is expanding into cloud integration as an alternative to the traditional heavyweight enterprise service bus (ESB). The company recently announced that it achieved more than 90% year-over-year growth. As Akana, the company now addresses the evolution and diversification of SOA, unifying security, management, and DevOps across SOA, APIs, microservices, and more.
Mar. 31, 2015 08:30 AM EDT Reads: 2,115
The list of ‘new paradigm’ technologies that now surrounds us appears to be at an all time high. From cloud computing and Big Data analytics to Bring Your Own Device (BYOD) and the Internet of Things (IoT), today we have to deal with what the industry likes to call ‘paradigm shifts’ at every level of IT. This is disruption; of course, we understand that – change is almost always disruptive.
Mar. 30, 2015 04:00 PM EDT Reads: 1,199
SYS-CON Events announced today that SafeLogic has been named “Bag Sponsor” of SYS-CON's 16th International Cloud Expo® New York, which will take place June 9-11, 2015, at the Javits Center in New York City, NY. SafeLogic provides security products for applications in mobile and server/appliance environments. SafeLogic’s flagship product CryptoComply is a FIPS 140-2 validated cryptographic engine designed to secure data on servers, workstations, appliances, mobile devices, and in the Cloud.
Mar. 30, 2015 11:00 AM EDT Reads: 1,558
GENBAND has announced that SageNet is leveraging the Nuvia platform to deliver Unified Communications as a Service (UCaaS) to its large base of retail and enterprise customers. Nuvia’s cloud-based solution provides SageNet’s customers with a full suite of business communications and collaboration tools. Two large national SageNet retail customers have recently signed up to deploy the Nuvia platform and the company will continue to sell the service to new and existing customers. Nuvia’s capabilities include HD voice, video, multimedia messaging, mobility, conferencing, Web collaboration, deskt...
Mar. 30, 2015 01:00 AM EDT Reads: 1,535
SYS-CON Media announced today that @WebRTCSummit Blog, the largest WebRTC resource in the world, has been launched. @WebRTCSummit Blog offers top articles, news stories, and blog posts from the world's well-known experts and guarantees better exposure for its authors than any other publication. @WebRTCSummit Blog can be bookmarked ▸ Here @WebRTCSummit conference site can be bookmarked ▸ Here
Mar. 29, 2015 10:00 PM EDT Reads: 1,885
SYS-CON Events announced today that Cisco, the worldwide leader in IT that transforms how people connect, communicate and collaborate, has been named “Gold Sponsor” of 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. Cisco makes amazing things happen by connecting the unconnected. Cisco has shaped the future of the Internet by becoming the worldwide leader in transforming how people connect, communicate and collaborate. Cisco and our partners are building the platform for the Internet of Everything by connecting the...
Mar. 29, 2015 07:00 PM EDT Reads: 5,293
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 compatible devices.
Mar. 29, 2015 06:00 PM EDT Reads: 1,897
Docker is an excellent platform for organizations interested in running microservices. It offers portability and consistency between development and production environments, quick provisioning times, and a simple way to isolate services. In his session at DevOps Summit at 16th Cloud Expo, Shannon Williams, co-founder of Rancher Labs, will walk through these and other benefits of using Docker to run microservices, and provide an overview of RancherOS, a minimalist distribution of Linux designed expressly to run Docker. He will also discuss Rancher, an orchestration and service discovery platf...
Mar. 29, 2015 04:15 PM EDT Reads: 2,479
SYS-CON Events announced today that Vitria Technology, Inc. will exhibit at SYS-CON’s @ThingsExpo, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. Vitria will showcase the company’s new IoT Analytics Platform through live demonstrations at booth #330. Vitria’s IoT Analytics Platform, fully integrated and powered by an operational intelligence engine, enables customers to rapidly build and operationalize advanced analytics to deliver timely business outcomes for use cases across the industrial, enterprise, and consumer segments.
Mar. 29, 2015 03:30 PM EDT Reads: 2,241