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:6/23/2016)... June 23, 2016  In a startling report released today, ... residents by lacking a comprehensive, proven plan to eliminate prescription opioid ... ranking of how states are tackling the worst drug crisis in ... states – Kentucky , New Mexico ... . Of the 28 failing states, three – ...
(Date:6/23/2016)... , June 23, 2016 Research ... MEMS Devices Medical Market Analysis 2016 - Forecast to 2022" ... The report contains up to date financial data ... analysis. Assessment of major trends with potential impact on the ... analysis of market segmentation which comprises of sub markets, regional ...
(Date:6/23/2016)... Research and Markets has announced the addition of ... their offering. The current ... environment for MedImmune to enter. The US ageing population creates ... drive considerable growth for effective anti-influenza medications. The introduction of ... but development is still in its infancy. ...
Breaking Medicine Technology:
(Date:6/26/2016)... Orion, Clarkston, Michigan (PRWEB) , ... June 26, ... ... with respect to fertility once they have been diagnosed with endometriosis. These women ... intercourse but they also require a comprehensive approach that can help for preservation ...
(Date:6/25/2016)... ... June 25, 2016 , ... Austin residents seeking Mohs ... College of Mohs Surgery and to Dr. Russell Peckham for medical and surgical dermatology. ... treatment for skin cancer. The selective fellowship in Mohs Micrographic Surgery completed by Dr. ...
(Date:6/25/2016)... ... June 25, 2016 , ... "With 30 hand-drawn hand gesture ... said Christina Austin - CEO of Pixel Film Studios. , ProHand Cartoon’s package ... Final Cut Pro X . Simply select a ProHand generator and drag it ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern Californian, ... and his M.D from the David Geffen School of Medicine at UCLA. He trained ... Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program where ...
(Date:6/25/2016)... ... 2016 , ... On Friday, June 10, Van Mitchell, Secretary of the Maryland ... iHire in recognition of their exemplary accomplishments in worksite health promotion. , The Wellness ... & Wellness Symposium at the BWI Marriott in Linthicum Heights. iHire was one of ...
Breaking Medicine News(10 mins):