yourfanat wrote: I am using another tool for Oracle developers - dbForge Studio for Oracle. This IDE has lots of usefull features, among them: oracle designer, code competion and formatter, query builder, debugger, profiler, erxport/import, reports and many others. The latest version supports Oracle 12C. More information here.
Cloud Expo on Google News
Cloud Expo & Virtualization 2009 East
Smarter Business Solutions Through Dynamic Infrastructure
Smarter Insights: How the CIO Becomes a Hero Again
Windows Azure
Why VDI?
Maximizing the Business Value of Virtualization in Enterprise and Cloud Computing Environments
Messaging in the Cloud - Email, SMS and Voice
Freedom OSS
Stairway to the Cloud
Sun's Incubation Platform: Helping Startups Serve the Enterprise
Cloud Computing & Enterprise IT: Cost & Operational Benefits
How and Why is a Flexible IT Infrastructure the Key To the Future?
Click For 2008 West
Event Webcasts
Radius Provides Update on Pivotal Phase 3 Program for BA058-SC Injection

CAMBRIDGE, MA -- (Marketwire) -- 01/07/13 -- Radius Health, Inc. ("Radius"), a biopharmaceutical company focused on developing new therapeutics for the treatment of osteoporosis and other women's health conditions, is providing an update regarding the progress of its Phase 3 study of BA058-Subcutaneous (SC). BA058 is a novel synthetic peptide analog of hPTHrP (human parathyroid hormone-related protein), an anabolic, bone-building drug being studied for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

An interim safety analysis was performed by the independent Data Safety Monitoring Board (DSMB) as part of its routine oversight of the pivotal Phase 3 study. At the latest meeting in November, the DSMB reviewed accumulated safety data on more than 75 percent of the planned 2,400 subjects and recommended that the trial continue unmodified. There have been no SAEs to date attributed to BA058.

As part of this DSMB review, a blinded analysis was performed on safety reports of clinical, non-vertebral fractures occurring in the study. The blinded (BA058/Placebo) versus open label (Forteo) arm has shown a lower non-vertebral fracture rate (1.2 percent in the blinded BA058/Placebo arm versus 1.9 percent in the Forteo arm).

"With the DSMB recommendation and the emerging blinded, interim fracture data, we believe that our Phase 3 trial is on track to demonstrate potentially favorable results in preventing non-vertebral fractures in postmenopausal women with osteoporosis at high risk for fracture," said Michael Wyzga, Radius president and chief executive officer.

The Phase 3 randomized, double-blind trial, which commenced enrollment in April 2011, is expected to enroll 2,400 patients and is studying BA058-SC as a daily subcutaneous injection in comparison to placebo and Forteo for safety and efficacy in preventing vertebral fractures as its primary endpoint (See The Phase 3 pivotal trial is projected to complete enrollment in the first quarter of 2013.

Currently, there are 29 clinical centers in 10 countries participating in this Phase 3 study, and all planned clinical centers are open. The earliest enrolling patients have completed the primary 18-month treatment phase of the program and have now enrolled into the 6-month extension study.

Additionally, Radius has met with the Swedish Medical Products Agency (MPA) to review the design and the overall progress of the Phase 3 program. The MPA has confirmed that the program, based on the current single pivotal trial design, would support the submission and potential approval of an MAA in Europe, pending the results of the Phase 3 study.

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. Radius also has a product in development to treat symptoms associated with menopause. Learn more by visiting the company's new website at

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 number of patients expected to be enrolled in the ongoing Phase 3 trial, the projected date by which the ongoing Phase 3 trial will be fully enrolled and the prospects for BA058-SC and BA058-TD, 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 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.


David Connolly
Vice President
LaVoie Group

Radius Health
Nick Harvey

About 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.

Latest Cloud Developer Stories
In his General Session at DevOps Summit, Asaf Yigal, Co-Founder & VP of Product at, explored the value of Kibana 4 for log analysis and provided a hands-on tutorial on how to set up Kibana 4 and get the most out of Apache log files. He examined three use cases: IT operat...
Discussions of cloud computing have evolved in recent years from a focus on specific types of cloud, to a world of hybrid cloud, and to a world dominated by the APIs that make today's multi-cloud environments and hybrid clouds possible. In this Power Panel at 17th Cloud Expo, mo...
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, Sam McIntyre, Partner Enablement Specialist at eFolder, p...
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York and Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can b...
Internet of @ThingsExpo, taking place June 7-9, 2016 at Javits Center, New York City and Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with the 18th International @CloudExpo and will feature technical sessions from a rock star conference fa...
Subscribe to the World's Most Powerful Newsletters
Subscribe to Our Rss Feeds & Get Your SYS-CON News Live!
Click to Add our RSS Feeds to the Service of Your Choice:
Google Reader or Homepage Add to My Yahoo! Subscribe with Bloglines Subscribe in NewsGator Online
myFeedster Add to My AOL Subscribe in Rojo Add 'Hugg' to Newsburst from CNET Kinja Digest View Additional SYS-CON Feeds
Publish Your Article! Please send it to editorial(at)!

Advertise on this site! Contact advertising(at)! 201 802-3021

SYS-CON Featured Whitepapers