Anges MG : Completion of Patient Enrollment in the Phase III Clinical Trials of NF-kB Decoy Oligonucleotide Ointment Drug for Atopic Dermatitis in Japan

Microsoft Word - 20150119_NF-kB_AD_LPI.doc

January 19, 2016 AnGes MG, Inc.

Completion of Patient Enrollment in the Phase III Clinical Trials of NF-kB Decoy Oligonucleotide Ointment Drug for Atopic Dermatitis in Japan

AnGes MG, Inc. ("AnGes") announced the completion of patient enrollment for the phase III clinical trial of its nucleic-acid drug, NF-kB Decoy Oligonucleotide (ointment drug), for Atopic Dermatitis in Japan.

The randomized, double-blind, and placebo-controlled Phase III clinical trial is designed to evaluate the efficacy and safety of the drug in approximately 200 atopic dermatitis patients with moderate to severe atopic skin symptoms on the face. AnGes began patient enrollment in March 2015. If the study produces favorable results, AnGes will submit an application for drug marketing approval in Japan for the indication of moderate to severe facial atopic dermatitis. Shionogi & Co., Ltd holds the exclusive marketing rights of NF-kB Decoy Oligonucleotide for dermatological diseases such as Atopic Dermatitis.

"We are pleased to announce that we have reached full enrollment ahead of our original schedule" said Ei Yamada, Ph.D., President and CEO of AnGes. "NF-kB Decoy Oligonucleotide as well as gene therapy with HGF Plasmid are two of our pivotal projects. We have been developing NF-kB Decoy Oligonucleotide since the time the company was established. Atopic Dermatitis is the first indication sought for clinical development. Moving forward, we will continue striving to deliver new treatment options to patients."

(Reference)

1. NF-κB (nuclear factor-kappa B)

   Genes play an important role in maintaining homeostasis; however most genes are usually not expressed. Transcription factors are proteins that regulate the expressions of genes when needed. NF-κB is the main transcription factor which when expressed, enables cells to evoke inflammatory and immune reactions when inflammation and immunity are activated, and when there is external stimulus such as oxidant stress due to active enzyme. It has been noted that the activation of NF-κB causes and worsens abnormal inflammation and immune related diseases such as atopic dermatitis, psoriasis and rheumatic arthritis.

   
   

2. Decoy Oligodeoxynucleotide

   A genetic expression manifests when a genetic factor bonds to a genome. A decoy is a short, double stranded nucleic acid comprized of the same DNA sequence as the genetic factor, which when introduced into the body neutralizes the genetic expression by preventing the factor from bonding to a genome.

   
   

3. NF-κB Decoy Oligodeoxynucleotide

NF-κB Decoy Oligodeoxynucleotide is a decoy oligo with the same genetic sequence as the NF-κB-binding site. As it targets the transcription factor itself, it is expected to have superior efficacy and milder side effects compared to conventional drugs, due to its specificity and definite effects on the molecular target. AnGes is developing therapeutic agents on the basis of its properties, to treat patients suffering from atopic dermatitis, rheumatic arthritis, and restenosis, which are conditions caused by excessive immunological response.

###

Disclaimer: This is a translation of the news release posted in Japanese. In case of any deviations between the two language versions, the original document in Japanese shall take precedence.

AnGesMG, Inc.

Corporate Communications TEL:[phone], FAX:[phone]

http://www.anges-mg.com