Navigation Links
AB103 Granted Orphan Medicinal Product Designation in the European Union for the Treatment of Necrotizing Soft Tissue Infections (NSTI)
Date:8/5/2014

NESS ZIONA, Israel, August 5, 2014 /PRNewswire/ --

Atox Bio today announced that the European Commission has granted AB103 (Sodium acetate salt of the synthetic peptide H-D-Ala-Ser-Pro-Met-Leu-Val-Ala-Tyr-Asp-D-Ala-OH) orphan medicinal product designation (EU/3/14/1294) for the treatment of necrotizing soft tissue infections. Atox Bio is represented in the EU by Dr. Ulrich Granzer as agent.

In addition to a 10-year period of marketing exclusivity in the EU after product approval, orphan designation provides fee reduction for companies seeking protocol assistance from the EMA, direct access to centralized marketing authorization as well as fee reduction for the centralized marketing authorization.

NSTI are rare, fast progressing infections that result in significant tissue destruction and systemic disease leading to multiple organ dysfunction. Currently, there are no approved treatments for NSTI and the standard of care includes prompt and repeated surgical debridement, aggressive resuscitation and physiologic support, in addition to antibiotics.

AB103, a novel immunomodulator, is a short peptide that modulates the host's inflammatory response through binding to the CD28 dimer interface. It offers a unique approach in the treatment of infectious diseases by modulating, but not inhibiting, the host immune system. This approach of targeting the host response rather than the pathogen precludes the rapid generation of drug resistance and provides a multisystem solution for bacterial infections with broad-spectrum coverage, independent of pathogen type.

AB103 successfully completed a Phase 2 study in patients with NSTI. The results demonstrated that patients treated with AB103 had a meaningful improvement across multiple end points. Patients treated with AB103 had a faster resolution of organ dysfunction, spent fewer days in the intensive care unit, required fewer days of assisted ventilation and needed fewer surgical procedures to remove infected tissue. A pivotal study is planned for the second half of 2015.

"Obtaining orphan designation for AB103 in the European Union is an important regulatory milestone for Atox Bio, supporting our global development plan after having received Orphan Drug designation and Fast Track status from the FDA. We are continuing development to bring to patients what could be the first therapy for this devastating and rare disease" said Dan Teleman, Chief Executive Officer of Atox Bio.

http://www.atoxbio.com


Media Contact:
Dan Teleman - CEO
Tel: +972-8-648-4111
E-mail: dant@atoxbio.com


'/>"/>
SOURCE Atox Bio
Copyright©2014 PR Newswire.
All rights reserved

Related medicine technology :

1. Inovio Pharmaceuticals Granted U.S. Patent Protection for Synthetic Vaccine for Cervical Dysplasia and Cancer
2. Broad Patent Protection Granted for iBio Immunomodulator
3. BiO2 Medical Granted CE Mark for the Angel™ Catheter, the First IVC Filter with a Prophylactic Use Indication
4. QRxPharma Granted Additional US Patent on MoxDuo®
5. Oramed Pharmaceuticals Granted Core Technology Patent in New Zealand
6. Unilife Granted Key U.S. Patent for Unifill Prefilled Syringe
7. Vomaris patent estate grows to six issued U.S. patents and three granted international patents with U.S. Pat. No. 8,224,439
8. OncoSec Granted New Patent from China
9. Albireo Has Been Granted Orphan Drug Designation for A4250 from the US FDA for the Treatment of Progressive Familial Intrahepatic Cholestasis (PFIC) and for Primary Biliary Cirrhosis (PBC)
10. Savara Pharmaceuticals AeroVanc Granted U.S. Orphan Drug Designation for the Treatment of MRSA Lung Infection in Cystic Fibrosis Patients
11. Harvest Technologies Corporation Granted CE Mark for Expanded Clinical Indication for Treatment of No-Option Critical Limb Ischemia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/25/2017)... R.I. , Sept. 25, 2017  EpiVax, ... assessment, vaccine design, and immune-engineering today announced the ... on the development of personalized therapeutic cancer vaccines. ... has provided exclusive access to enabling technologies to ... Eng., MBA will lead EpiVax Oncology as Chief ...
(Date:9/19/2017)... Sept. 19, 2017   ZirMed Inc ., a recognized ... announced that it has been ranked #1 by its users ... Rankings 2017 User Survey. ZirMed was recognized as the ... hospitals and medical centers over 200 beds and holds one ... technology user survey history. ...
(Date:9/12/2017)... MOUNTAIN LAKES, N.J. , Sept. 12, 2017  Consumer reviews ... Embrace Hearing as the number one company for hearing ... Oticon™, ReSound™ and fifteen other brands. ... Embrace Hearing Named #1 by Consumers For Hearing Aids ... Embrace Hearing is an online store that ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... Lori R. Somekh, founder ... of ElderCounsel, a national organization of elder law and special needs planning attorneys. “Membership ... rules. It also provides a forum to network with elder law attorneys nationwide,” said ...
(Date:10/13/2017)... NJ (PRWEB) , ... October 13, 2017 , ... Global ... at scenic Alexandria Park in Milford, NJ. This free event, sponsored by Global ... physical activity. The fun run is geared towards children of all ages; it ...
(Date:10/13/2017)... ... October 13, 2017 , ... “America On The Brink”: the Christian ... On The Brink” is the creation of published author, William Nowers. Captain Nowers ... a WWII veteran, he spent thirty years in the Navy. Following his career ...
(Date:10/12/2017)... PALM CITY, Fla. (PRWEB) , ... October 12, 2017 , ... ... of cold therapy products, announced today the introduction of an innovative new design of ... the multipurpose pad so you get maximum comfort while controlling your pain while using ...
(Date:10/12/2017)... ... 12, 2017 , ... HMP , a leader in healthcare events and ... Eddie Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were announced during the Eddie ... annual award competition recognizes editorial and design excellence across a range of sectors. This ...
Breaking Medicine News(10 mins):