AnGes Announces First Patient Treated with NF-kappa B Decoy in Phase Ib Study to Treat Discogenic Low Back Pain

TOKYO, Feb. 28, 2018 -- AnGes, Inc., a biopharmaceutical company focused on developing innovative gene-based medicines for serious diseases, announced today the treatment of the first patient with NF-kappa B decoy oligo DNA (NF-kB Decoy) in the US phase Ib clinical trial in patients with chronic discogenic low back pain (DLBP).

This clinical trial will evaluate increasing doses of NF-kB Decoy that are injected directly into the intervertebral disc, and be conducted on up to 24 patients with chronic DLBP. The study will track progress over 12 months after treatment to evaluate safety and exploratory efficacy. “We are excited to announce the first patient treatment in this ‘first in man’ clinical study evaluating NF-kB Decoy, an innovative drug candidate based on our oligonucleotide technologies”, said Dr. Ei Yamada, Chief Executive Officer of AnGes, Inc.

NF-kB Decoy suppresses release of inflammatory cytokines (physiologically active substances that are secreted by cells) and therefore has the potential to become an effective therapeutic agent for the treatment of various disorders caused by excessive inflammatory reactions and immune responses. Currently, the only pharmaceutical therapy approved by the US FDA for chronic DLBP is symptomatic treatment by anti-inflammatory analgesics. NF-kB Decoy differs from existing analgesics because it exerts its effect by inhibiting the causative agent. The results of basic scientific research suggest that local injection of NF-kB Decoy is also effective in treating intervertebral disc degeneration, helping restore disc height, and suppressing the progression of the disease, which cannot be treated with existing therapeutic agents.

Chronic low back pain affects a large population worldwide and causes a high economic burden to societies, primarily due to lost productivity and wages.  As a result of these demographics, and the debilitating nature of chronic DLBP, NF-kB Decoy has a large market potential in this clinical indication. AnGes will continue its efforts to develop this groundbreaking therapeutic agent for the treatment of chronic DLBP.　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　　

About AnGes
AnGes is a biopharmaceutical company focused on the development and commercialization of gene-based medicines including gene therapy and oligonucleotide medicines. In addition to NF-kB Decoy, AnGes develops HGF plasmid, a gene therapy drug candidate for critical limb ischemia (CLI). The company is located in Tokyo and Osaka, Japan and listed on Mothers of Tokyo Stock Exchange, a market for emerging companies.

Forward-Looking Statement
This news release contains forward-looking statements. Any forward-looking statements are based on the current expectations of the company’s management and are subject to significant risks and uncertainties.

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

AnGes, Inc.
Corporate Communications
http://www.anges-mg.com
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