EpiBone, Inc.が骨製品EB-CMFのヒト初回投与・第1/2相試験を開始するためのFDAの承諾を得る

AsiaNet 78859（0913）

【ニューヨーク2019年5月22日PR Newswire＝共同通信JBN】

＊幹細胞をベースにした骨置換のための潜在力のある画期的技術

EpiBone, Inc.は22日、米食品医薬品局（FDA）が下顎枝連続欠損の潜在的治療法として同社の主要な骨製品であるEpiBone-Craniomaxillofacial（EB-CMF）の第1/2相臨床試験を開始するための治験新薬（IND）の承諾を与えたと発表した。下顎枝は、そしゃくと関係のある筋肉に結合している顎骨の主要な構成要素である。

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EB-CMFは、患者自身の脂肪から抽出された幹細胞から作られる生体の解剖学的に正確な骨移植片である。これにより、患者の肉体から骨を採取する必要がなくなり、潜在的に痛みや手術および入院の時間を減らすとともに、欠損に合致した精度を生み出す。

EpiBoneの最高経営責任者（CEO）兼共同創立者であるニーナ・タンドン博士は「私たちはこのINDに注ぎ込まれた仕事を誇りに思うとともに、われわれのチーム全体、そして、全ての投資家、コンサルタント、このことを可能にしたこの分野の擁護者に感謝している。私たちの技術は、知っての通り、骨格再建の分野を変える可能性を持っている。私たちの目標は、できるだけ多くの患者が最もシームレスで長期的かつ自然な方法で、最適な形態、機能を取り戻すのを助けることである」とコメントした。

第1/2相の臨床研究は、直接、再建を必要とする下顎枝連続欠損のある患者においてEB-CMF 製品を評価する。EB-CMFの基礎的安全性のほか、同研究は、天然組織との一体化とともに骨格再建におけるEB-CMFの有効性を実証することも目的としている。同社は、この研究に6人の患者を参加させることを見込んでいる。同社は、この研究が骨移植片を必要とする他の顔面再建手術の潜在的適応の診査、ならびに膝や他の肉体の部位の軟骨置換の研究についての情報を与えることを願っている。

▽EpiBoneについて

EpiBone, Inc.は、骨格再建を専門とする株式非公開の再生医療会社である。生物学と工学の交点に位置する同社は、患者自身の細胞の能力を生かし、患者の肉体のシームレスな部位となる生体ソリューションを創出する。EpiBoneは現在、骨、軟骨および複合物（骨と軟骨）製品のパイプラインを開発している。

詳しい情報はhttps://www.epibone.com/ を参照。

ソース：EpiBone, Inc.

▽問い合わせ先

Blake Wheeler

blake@epibone.com

EpiBone, Inc. Receives FDA Clearance to Commence its First-In-Human, Phase 1/2 Trial of its Bone Product, EB-CMF

PR78859

NEW YORK, May 22, 2019 /PRNewswire=KYODO JBN/ --

-- Potential breakthrough technology for stem-cell based bone replacement

EpiBone, Inc. today announced that the U.S. Food and Drug Administration (FDA)

has granted its Investigational New Drug (IND) clearance to proceed with a

Phase 1/2 clinical trial of its lead bone product EpiBone-Craniomaxillofacial

(EB-CMF), as a potential treatment for ramus continuity defects in the mandible.

The ramus is a key component of the jaw bone which attaches to the muscles

associated with chewing.

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EB-CMF is a living anatomically correct bone graft manufactured from a

patient's own adipose derived stem cells. This eliminates the need to harvest

bone from a patient's body, potentially reducing pain, surgical and

hospitalization time while creating a precision fit with the defect.

"We are proud of the work that has been put into this IND, and are grateful to

our entire team, as well as all our investors, consultants, and champions in

the field who have made this possible," commented Dr. Nina Tandon, CEO and

Co-Founder of EpiBone. "Our technology has the potential to change the field of

skeletal reconstruction as we know it. Our goal is to help as many patients as

we can to regain optimal form and function, in the most seamless, long-term,

and natural way possible."

The Phase 1/2 clinical study will evaluate the EB-CMF product directly in

patients with mandibular ramus continuity defects which require reconstruction.

In addition to the primary safety of EB-CMF, the study is also designed to

demonstrate the effectiveness of EB-CMF in bone reconstruction in addition to

integration with the native tissue. The company expects to enroll 6 patients in

this study. The company hopes this study will inform the exploration of other

potential indications for other facial reconstructive surgeries requiring bone

grafts, as well as studies for cartilage replacement in the knee, and other

areas of the body.

About EpiBone

EpiBone, Inc. is privately-held regenerative medicine company focused on

skeletal reconstruction. Sitting at the intersection of biology and engineering,

the company harnesses the power of a patient's own cells to create living

solutions that become a seamless part of a patient's body. EpiBone is currently

developing a pipeline of bone, cartilage, and compound (bone and cartilage) products.

For more information, please visit: https://www.epibone.com/

Disclaimer

This communication contains forward-looking statements which can generally can

be identified by words such as "plans," "change," "will," "following",

"strengthening," "developing, the negative of these words and similar words and

expressions, which are based on EpiBone's current expectations, assumptions,

estimates and projections about its business, technology, product development

and industry. Such forward-looking statements are subject to risks and

uncertainties that could cause actual results to differ materially and include,

without limitation, EpiBone's ability to (1) adequately protect or enforce its

intellectual property rights, (2) develop and commercialize new products and

technologies on a timely basis (or at all), (3) risks associated with

acquisitions and strategic investments and (4) attract and retain qualified

personnel. Accordingly, you are cautioned not to place undue reliance on such

forward-looking statements. Additionally, this communication does not

constitute an offer to sell or a solicitation of an offer to buy securities.

SOURCE EpiBone, Inc.

CONTACT: Blake Wheeler, blake@epibone.com