Comments
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.

2008 West
DIAMOND SPONSOR:
Data Direct
SOA, WOA and Cloud Computing: The New Frontier for Data Services
PLATINUM SPONSORS:
Red Hat
The Opening of Virtualization
GOLD SPONSORS:
Appsense
User Environment Management – The Third Layer of the Desktop
Cordys
Cloud Computing for Business Agility
EMC
CMIS: A Multi-Vendor Proposal for a Service-Based Content Management Interoperability Standard
Freedom OSS
Practical SOA” Max Yankelevich
Intel
Architecting an Enterprise Service Router (ESR) – A Cost-Effective Way to Scale SOA Across the Enterprise
Sensedia
Return on Assests: Bringing Visibility to your SOA Strategy
Symantec
Managing Hybrid Endpoint Environments
VMWare
Game-Changing Technology for Enterprise Clouds and Applications
Click For 2008 West
Event Webcasts

2008 West
PLATINUM SPONSORS:
Appcelerator
Get ‘Rich’ Quick: Rapid Prototyping for RIA with ZERO Server Code
Keynote Systems
Designing for and Managing Performance in the New Frontier of Rich Internet Applications
GOLD SPONSORS:
ICEsoft
How Can AJAX Improve Homeland Security?
Isomorphic
Beyond Widgets: What a RIA Platform Should Offer
Oracle
REAs: Rich Enterprise Applications
Click For 2008 Event Webcasts
SYS-CON.TV
Today's Top SOA Links


Scioderm's Investigational New Drug (IND) Application for SD-101 for Treatment of Epidermolysis Bullosa (EB) Allowed by the FDA

RALEIGH, N.C., Feb. 13, 2013 /PRNewswire-iReach/ -- Scioderm announced that the US Food and Drug Administration (FDA) has reviewed and allowed the investigational new drug (IND) application for SD-101 to proceed.  SD-101 is a topical treatment being developed for the treatment of Epidermolysis Bullosa (EB).  The Company plans to initiate a Phase 1 study in the coming months, with initiation of the Phase 2B/3 study in EB patients to occur in the second half of 2013. 

EB is a rare genetic condition that in all of its forms, share the prominent manifestation of extremely fragile skin that blisters or tears with the slightest friction or trauma.  The disease affects not only the skin but also many internal organs and bodily systems.  This particular manifestation has led to EB patients being known as Butterfly children due to the analogous nature of the fragility of the skin to the wings of a butterfly.  As of today there is no cure or effective treatment.  Wound care, pain management and preventative bandaging are the only options available for caregivers, usually the parents or other family members.  The more severe forms of the disease lead to scarring, disfigurement, disability and early death, usually before the age of 30. 

"We are excited to reach this important corporate milestone and to advance this novel therapy in the clinic," stated Robert Ryan, Ph.D., Chairman of the Board and Co-Founder of Scioderm.  "We look forward to continuing our rapid development of this program to treat a disease where there are no current effective therapies.  In addition, we look forward to working closely with the FDA to expedite the continuing clinical testing and regulatory review of SD-101." 

 "I am enthused by the results SD-101 has demonstrated and with the rapid progress Scioderm has achieved in bringing this potential treatment to the clinic," said Brett Kopelan , Executive Director of the Dystrophic EB Research Association of America (DebRA ) and father to a 5-year-old girl with recessive dystrophic EB.  "I look forward to working with Scioderm as they work towards improving the quality of life of those with EB by targeting the chronic wounds that are the hallmark of this disease."

About SD-101

SD-101 is a topical cream that has previously demonstrated potential to provide improvement in treating the severe skin effects seen in patients across all EB subtypes.  An open- label study was conducted previously in children with either Simplex, Recessive Dystrophic (RDEB), or Junctional EB.  The primary outcome measurements were assessment of target wound reduction and closure, and reduction in body surface area (BSA) coverage of lesions and erosions.  In the clinical trial, SD-101 application resulted in complete closure of 88% of target chronic lesions within one month, in addition to a 57% reduction in BSA coverage of lesions and erosions after 3 months of daily treatment.   SD-101 was well tolerated by the children, with daily administration up to 3 months.

About Scioderm

Scioderm is a privately held, clinical-stage pharmaceutical company focused on developing topical products to address critical medical needs in the treatment of chronic skin diseases.  Additional information about Scioderm can be found at www.sderm.com

Company Contact:

Robert Coull
Chief Operating Officer
robert.coull@sderm.com  
(917) 345-2504   

Forward-Looking Statements 

Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties, including: our dependence on third parties for the development, regulatory approval and successful commercialization of our products, the inherent risk of failure in developing product candidates based on new technologies, risks associated with the costs of clinical development efforts, as well as other risks.  Actual results may differ materially from those projected.  These forward-looking statements represent our judgment as of the date of the release.  Scioderm disclaims any intent or obligation to update these forward-looking statements.

Media Contact: Robert Coull, Scioderm, 917-345-2504, robert.coull@sderm.com

News distributed by PR Newswire iReach: https://ireach.prnewswire.com

SOURCE Scioderm

About PR Newswire
Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Web 2.0 Latest News
So congratulations, somehow you've managed to wangle your way onto one of the many DevOps conferences being held around the world. Why not you might say? DevOps is not only hot it's the approach many enterprises are now exploring as the means to help accelerate the delivery of high qua...
Change is constant, and over the last decade the nexus of two trends in particular has transformed the enterprise. Mobile technology and cloud software are fundamentally changing the way we interact internally within businesses, and externally with partners and customers. Never befor...
What does the data landscape look like at Facebook with its 1.3 billion users across the globe? They classify small data referring to OLTP-like queries that process and retrieve a small amount of data, usually 1-1000 objects requested by their …
If you thought the Bring Your Own Device (BYOD) craze was a headache, just wait until button cameras, smart watches, and spy glasses (already here) are a daily occurrence in the office. Workplace #Wearables will be a huge challenge in the coming years as more devices, clothing and pret...
It does not take much to understand the benefits of the DevOps culture, processes, and tools. However, implementing DevOps in your organization is not as obvious and usually involves more than simply setting up tools. You have to convince team members, map old processes to new, and ma...
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 News.com Kinja Digest View Additional SYS-CON Feeds
Publish Your Article! Please send it to editorial(at)sys-con.com!

Advertise on this site! Contact advertising(at)sys-con.com! 201 802-3021




SYS-CON Featured Whitepapers
ADS BY GOOGLE