Navigation Links
Scioderm's Investigational New Drug (IND) Application for SD-101 for Treatment of Epidermolysis Bullosa (EB) Allowed by the FDA
Date:2/13/2013

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
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Sanofi Pasteur Presents Pediatric Data on Investigational Quadrivalent Influenza Vaccine
2. Data from Study of Elderly Depressed Patients are Reported for Investigational Compound Lu AA21004 on Symptoms of Major Depressive Disorder (MDD)
3. Ambit Biosciences and Teva Announce Clearance of an Investigational New Drug (IND) Application for CEP-32496, A Novel BRAF(V600E) Inhibitor
4. Results of Phase II Study of Boehringer Ingelheims Investigational Bronchodilator for COPD Presented at 2012 ATS International Conference
5. Lilly Diabetes Presents Phase II Blood Pressure and Heart Rate Data on Investigational GLP-1 Analog Candidate, Dulaglutide, in Patients with Type 2 Diabetes at the 27th American Society of Hypertension Scientific Meeting
6. Lilly and Boehringer Ingelheim Present Data at the 72nd American Diabetes Association Scientific Sessions® from Phase II Studies Comparing Investigational Novel Basal Insulin to Insulin Glargine
7. Abbott Presents Results of Clinical Studies Evaluating Its Investigational Treatment for Advanced Parkinsons Disease
8. Results For Phase 2b Trial Of Unique Investigational Cell-Based Therapy In Venous Leg Ulcers Published In The Lancet
9. Janssen Biotech Announces Global License and Development Agreement for Investigational Anti-Cancer Agent Daratumumab
10. Clinical Study With Investigational Cream Aims To Help Women Who Experience Painful Sex
11. Omeros Files Investigational New Drug Application for Lead Compound in PDE10 Program
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/11/2016)... WILMINGTON, N.C. , Feb. 11, 2016 /PRNewswire/ ... a leading provider of custom manufacturing and development ... announces expanded sterile fill-finish capabilities and capacity in ... Substantial growth in demand has driven several recent ... in 2001 it had one filling line with ...
(Date:2/11/2016)... , 11 de fevereiro de 2016 /PRNewswire/ ... de sua fábrica de soroalbumina bovina (BSA -- ... A fábrica fica na Ilha Norte da Nova ... desenvolvido e estabelecido na fábrica da Proliant nos ... . O projeto e instalação dos equipamentos foram ...
(Date:2/11/2016)... February 11, 2016 Breast Cancer Therapeutics ... Asia-Pacific (APAC) breast cancer market will ... billion by 2021, at a Compound Annual Growth Rate (CAGR) ... Markets to 2021 - states that the ... expansion from $1.9 billion in 2014 to $3.4 billion by ...
Breaking Medicine Technology:
(Date:2/11/2016)... ... February 11, 2016 , ... Be Well Medical Group ... heart of Old Town at 108 South Columbus St, Suite 201, Alexandria, VA. Be ... of medical care in the convenience of their homes, offices or at the practices’ ...
(Date:2/11/2016)... , ... February 11, 2016 , ... ... dynamometers and ergoFET force gauges used in physical therapy, occupational therapy and sports ... sensor for resistance cord exercise and therapy, introduces its new microFET Digital Pinch ...
(Date:2/11/2016)... (PRWEB) , ... February 11, 2016 , ... ... have become more actively engaged in health and wellness best practices in the ... of riding this trend. February is American Heart Month, which acts as an ...
(Date:2/11/2016)... ... February 11, 2016 , ... Research led ... rates of several common cancer screenings, especially among women. Cancer screenings are often ... rates. , The study,“What Does Medicaid Expansion Mean for Cancer Screening and ...
(Date:2/10/2016)... ... February 10, 2016 , ... President Obama’s budget proposal ... to deliver medical services via telehealth, estimated to generate more than $160 million ... language for many years. Although there is more to be done, this ...
Breaking Medicine News(10 mins):