Welcome!

Agile Computing Authors: ManageEngine IT Matters, Elizabeth White, Liz McMillan, Carmen Gonzalez, Yeshim Deniz

News Feed Item

Radius Completes Enrollment for Phase 2 Study of BA058-Transdermal Patch for Treatment of Postmenopausal Osteoporosis

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.

About 3M

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.

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

@ThingsExpo Stories
Five years ago development was seen as a dead-end career, now it’s anything but – with an explosion in mobile and IoT initiatives increasing the demand for skilled engineers. But apart from having a ready supply of great coders, what constitutes true ‘DevOps Royalty’? It’ll be the ability to craft resilient architectures, supportability, security everywhere across the software lifecycle. In his keynote at @DevOpsSummit at 20th Cloud Expo, Jeffrey Scheaffer, GM and SVP, Continuous Delivery Busine...
SYS-CON Events announced today that Outscale will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Outscale's technology makes an automated and adaptable Cloud available to businesses, supporting them in the most complex IT projects while controlling their operational aspects. You boost your IT infrastructure's reactivity, with request responses that only take a few seconds.
SYS-CON Events announced today that Progress, a global leader in application development, has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Enterprises today are rapidly adopting the cloud, while continuing to retain business-critical/sensitive data inside the firewall. This is creating two separate data silos – one inside the firewall and the other outside the firewall. Cloud ISVs ofte...
SYS-CON Events announced today that Interoute has been named “Bronze Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Interoute is the owner operator of Europe's largest network and a global cloud services platform, which encompasses over 70,000 km of lit fiber, 15 data centers, 17 virtual data centers and 33 colocation centers, with connections to 195 additional partner data centers. Our full-service Unifie...
SYS-CON Events announced today that CollabNet, a global leader in enterprise software development, release automation and DevOps solutions, will be a Bronze Sponsor of SYS-CON's 20th International Cloud Expo®, taking place from June 6-8, 2017, at the Javits Center in New York City, NY. CollabNet offers a broad range of solutions with the mission of helping modern organizations deliver quality software at speed. The company’s latest innovation, the DevOps Lifecycle Manager (DLM), supports Value S...
SYS-CON Events announced today that Enzu will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. Enzu’s mission is to be the leading provider of enterprise cloud solutions worldwide. Enzu enables online businesses to use its IT infrastructure to their competitive ad...
SYS-CON Events announced today that Peak 10, Inc., a national IT infrastructure and cloud services provider, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Peak 10 provides reliable, tailored data center and network services, cloud and managed services. Its solutions are designed to scale and adapt to customers’ changing business needs, enabling them to lower costs, improve performance and focus intern...
Everywhere we turn in our industry we can find strong opinions about the direction, type and nature of cloud’s impact on computing and business. Another word that is used in every context in our industry is “hybrid.” In his session at 20th Cloud Expo, Alvaro Gonzalez, Director of Technical, Partner and Field Marketing at Peak 10, will use a combination of a few conceptual props and some research recently commissioned by Peak 10 to offer a real-world consideration of how the various categories of...
Detecting internal user threats in the Big Data eco-system is challenging and cumbersome. Many organizations monitor internal usage of the Big Data eco-system using a set of alerts. This is not a scalable process given the increase in the number of alerts with the accelerating growth in data volume and user base. Organizations are increasingly leveraging machine learning to monitor only those data elements that are sensitive and critical, autonomously establish monitoring policies, and to detect...
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
The 21st International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held October 31 - November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, Machine Learning and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding busin...
Multiple data types are pouring into IoT deployments. Data is coming in small packages as well as enormous files and data streams of many sizes. Widespread use of mobile devices adds to the total. In this power panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists will look at the tools and environments that are being put to use in IoT deployments, as well as the team skills a modern enterprise IT shop needs to keep things running, get a handle on all this data, and deli...
SYS-CON Events announced today that Systena America will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Systena Group has been in business for various software development and verification in Japan, US, ASEAN, and China by utilizing the knowledge we gained from all types of device development for various industries including smartphones (Android/iOS), wireless communication, security technology and IoT serv...
SYS-CON Events announced today that Loom Systems will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Founded in 2015, Loom Systems delivers an advanced AI solution to predict and prevent problems in the digital business. Loom stands alone in the industry as an AI analysis platform requiring no prior math knowledge from operators, leveraging the existing staff to succeed in the digital era. With offices in S...
With major technology companies and startups seriously embracing Cloud strategies, now is the perfect time to attend @CloudExpo | @ThingsExpo, June 6-8, 2017, at the Javits Center in New York City, NY and October 31 - November 2, 2017, Santa Clara Convention Center, CA. Learn what is going on, contribute to the discussions, and ensure that your enterprise is on the right path to Digital Transformation.
SYS-CON Events announced today that EARP Integration will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. EARP Integration is a passionate software house. Since its inception in 2009 the company successfully delivers smart solutions for cities and factories that start their digital transformation. EARP provides bespoke solutions like, for example, advanced enterprise portals, business intelligence systems an...
We build IoT infrastructure products - when you have to integrate different devices, different systems and cloud you have to build an application to do that but we eliminate the need to build an application. Our products can integrate any device, any system, any cloud regardless of protocol," explained Peter Jung, Chief Product Officer at Pulzze Systems, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA
Existing Big Data solutions are mainly focused on the discovery and analysis of data. The solutions are scalable and highly available but tedious when swapping in and swapping out occurs in disarray and thrashing takes place. The resolution for thrashing through machine learning algorithms and support nomenclature is through simple techniques. Organizations that have been collecting large customer data are increasingly seeing the need to use the data for swapping in and out and thrashing occurs ...
DevOps is often described as a combination of technology and culture. Without both, DevOps isn't complete. However, applying the culture to outdated technology is a recipe for disaster; as response times grow and connections between teams are delayed by technology, the culture will die. A Nutanix Enterprise Cloud has many benefits that provide the needed base for a true DevOps paradigm.
SYS-CON Events announced today that delaPlex will exhibit at SYS-CON's @CloudExpo, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. delaPlex pioneered Software Development as a Service (SDaaS), which provides scalable resources to build, test, and deploy software. It’s a fast and more reliable way to develop a new product or expand your in-house team.