Welcome!

Agile Computing Authors: Pat Romanski, Shelly Palmer, Glenda Sims, Paul Simmons, APM Blog

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.

CONTACT:

Media
David Connolly
Vice President
LaVoie Group
617-374-8800
[email protected]

Radius Health
Corporate
Nick Harvey
CFO
617-551-4700

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
DX World EXPO, LLC, a Lighthouse Point, Florida-based startup trade show producer and the creator of "DXWorldEXPO® - Digital Transformation Conference & Expo" has announced its executive management team. The team is headed by Levent Selamoglu, who has been named CEO. "Now is the time for a truly global DX event, to bring together the leading minds from the technology world in a conversation about Digital Transformation," he said in making the announcement.
"Space Monkey by Vivent Smart Home is a product that is a distributed cloud-based edge storage network. Vivent Smart Home, our parent company, is a smart home provider that places a lot of hard drives across homes in North America," explained JT Olds, Director of Engineering, and Brandon Crowfeather, Product Manager, at Vivint Smart Home, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Events announced today that Conference Guru has been named “Media Sponsor” of the 22nd International Cloud Expo, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. A valuable conference experience generates new contacts, sales leads, potential strategic partners and potential investors; helps gather competitive intelligence and even provides inspiration for new products and services. Conference Guru works with conference organizers to pass great deals to gre...
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, demonstrated how to move beyond today's coding paradigm and shared the must-have mindsets for removing complexity from the develop...
In his Opening Keynote at 21st Cloud Expo, John Considine, General Manager of IBM Cloud Infrastructure, led attendees through the exciting evolution of the cloud. He looked at this major disruption from the perspective of technology, business models, and what this means for enterprises of all sizes. John Considine is General Manager of Cloud Infrastructure Services at IBM. In that role he is responsible for leading IBM’s public cloud infrastructure including strategy, development, and offering m...
"Evatronix provides design services to companies that need to integrate the IoT technology in their products but they don't necessarily have the expertise, knowledge and design team to do so," explained Adam Morawiec, VP of Business Development at Evatronix, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
To get the most out of their data, successful companies are not focusing on queries and data lakes, they are actively integrating analytics into their operations with a data-first application development approach. Real-time adjustments to improve revenues, reduce costs, or mitigate risk rely on applications that minimize latency on a variety of data sources. In his session at @BigDataExpo, Jack Norris, Senior Vice President, Data and Applications at MapR Technologies, reviewed best practices to ...
Widespread fragmentation is stalling the growth of the IIoT and making it difficult for partners to work together. The number of software platforms, apps, hardware and connectivity standards is creating paralysis among businesses that are afraid of being locked into a solution. EdgeX Foundry is unifying the community around a common IoT edge framework and an ecosystem of interoperable components.
Large industrial manufacturing organizations are adopting the agile principles of cloud software companies. The industrial manufacturing development process has not scaled over time. Now that design CAD teams are geographically distributed, centralizing their work is key. With large multi-gigabyte projects, outdated tools have stifled industrial team agility, time-to-market milestones, and impacted P&L stakeholders.
"Akvelon is a software development company and we also provide consultancy services to folks who are looking to scale or accelerate their engineering roadmaps," explained Jeremiah Mothersell, Marketing Manager at Akvelon, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
"IBM is really all in on blockchain. We take a look at sort of the history of blockchain ledger technologies. It started out with bitcoin, Ethereum, and IBM evaluated these particular blockchain technologies and found they were anonymous and permissionless and that many companies were looking for permissioned blockchain," stated René Bostic, Technical VP of the IBM Cloud Unit in North America, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Conventi...
In his session at 21st Cloud Expo, Carl J. Levine, Senior Technical Evangelist for NS1, will objectively discuss how DNS is used to solve Digital Transformation challenges in large SaaS applications, CDNs, AdTech platforms, and other demanding use cases. Carl J. Levine is the Senior Technical Evangelist for NS1. A veteran of the Internet Infrastructure space, he has over a decade of experience with startups, networking protocols and Internet infrastructure, combined with the unique ability to it...
22nd International Cloud Expo, taking place June 5-7, 2018, at the Javits Center in New York City, NY, and co-located with the 1st DXWorld Expo will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud ...
"Cloud Academy is an enterprise training platform for the cloud, specifically public clouds. We offer guided learning experiences on AWS, Azure, Google Cloud and all the surrounding methodologies and technologies that you need to know and your teams need to know in order to leverage the full benefits of the cloud," explained Alex Brower, VP of Marketing at Cloud Academy, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clar...
Gemini is Yahoo’s native and search advertising platform. To ensure the quality of a complex distributed system that spans multiple products and components and across various desktop websites and mobile app and web experiences – both Yahoo owned and operated and third-party syndication (supply), with complex interaction with more than a billion users and numerous advertisers globally (demand) – it becomes imperative to automate a set of end-to-end tests 24x7 to detect bugs and regression. In th...
"MobiDev is a software development company and we do complex, custom software development for everybody from entrepreneurs to large enterprises," explained Alan Winters, U.S. Head of Business Development at MobiDev, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Coca-Cola’s Google powered digital signage system lays the groundwork for a more valuable connection between Coke and its customers. Digital signs pair software with high-resolution displays so that a message can be changed instantly based on what the operator wants to communicate or sell. In their Day 3 Keynote at 21st Cloud Expo, Greg Chambers, Global Group Director, Digital Innovation, Coca-Cola, and Vidya Nagarajan, a Senior Product Manager at Google, discussed how from store operations and ...
"There's plenty of bandwidth out there but it's never in the right place. So what Cedexis does is uses data to work out the best pathways to get data from the origin to the person who wants to get it," explained Simon Jones, Evangelist and Head of Marketing at Cedexis, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Events announced today that CrowdReviews.com has been named “Media Sponsor” of SYS-CON's 22nd International Cloud Expo, which will take place on June 5–7, 2018, at the Javits Center in New York City, NY. CrowdReviews.com is a transparent online platform for determining which products and services are the best based on the opinion of the crowd. The crowd consists of Internet users that have experienced products and services first-hand and have an interest in letting other potential buye...
SYS-CON Events announced today that Telecom Reseller has been named “Media Sponsor” of SYS-CON's 22nd International Cloud Expo, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.