Dipexium PharmaceuticalsがOneStep-1の第3相臨床試験の患者募集の目標達成を発表

AsiaNet 64428（0602）

【ニューヨーク2016年5月16日PR Newswire＝共同通信JBN】

＊両ピボタル第3相臨床試験ともこれで達成

後期段階医薬品会社で、薬効範囲の広い新しい局所抗生物質ペプチドであるLocilex（R）（一般名ペキシガナン・クリーム0.8%）の開発、商業化に集中しているDipexium Pharmaceuticals, Inc.（Nasdaq: DPRX）は16日、OneStep-1の臨床試験プロトコルに記載されている必要条件に従って、OneStep-1のピボタル第3相臨床試験の患者募集の目標を達成したと発表した。同社は最近、OneStep-2の臨床試験プロトコルに記載されている必要条件に従ってOneStep-2のピボタル第3相臨床試験の患者募集目標を達成したと発表していた。OneStep-1とOneStep-2は、糖尿病性の足部潰瘍の軽度化のう（軽度DFI）患者の治療におけるLocilexの評価のために米食品医薬品局（FDA）とDipexiumが結んだ「特別プロトコル評価」合意の下で行われた同一のピボタル第3相臨床試験である。

両臨床試験で臨床試験の場所はいまでは閉鎖される段階にあり、一部の試験センターではOneStep臨床プロトコルに記載されているように薬物動態（PK）分析用に必要な数の血液サンプルを収集するために約30日間の募集を続ける。

同社は両ピボタル第3相臨床試験のトップラインのデータを2016年第3四半期に発表する予定であり、FDAへの新薬申請（NDA）、欧州医薬品庁（EMA）への販売認可申請（MAA）は2017年前半を目標としている。

Dipexiumのロバート・J・デラクシア執行役員会長は「これらの記念すべきOneStep臨床試験に参加したすべての同僚たちの新しい局所抗生物質開発計画へのサポート、献身に感謝する。また、ボランティアとしてこの重要で画期的な研究に加わった患者たちにも感謝する。これで当社はリソースをこれらの臨床結果をまとめ、分析し、組み立てて、現在並行して進行中の米国、欧州向けの新薬申請、販売認可申請のパッケージに向けることができる」と語っている。

デラクシア氏は続けて「これらの試験が成功すれば、Locilexが軽度化のうの糖尿病性足部潰瘍を治療する抗生物質の標準になると予測している。また、現在の世界的なバクテリア耐性の危機と全身性抗生物質の過剰使用を抑制しようとする医療共同体による抗生物質管理努力を考慮すると、これは公共保健に対する意味のある貢献になると信じている」と述べている。

▽OneStep-1、OneStep-2の試験設計

OneSteo-1、OneStep-2は同一のダブルブラインド、偽薬対比の臨床試験で、同時に行われた。プライマリー・エンドポイントは軽度DFIの治療で、偽薬クリームおよび標準的な局所病創ケアと比較して局所Locilexおよび標準的な局所病創ケアが臨床的優秀性、安全性を確立することである。患者は無作為で1対1に分けられ、局所Locilexおよび標準的局所病創ケアか偽薬クリームおよび標準的な局所病創ケアを14日間受け、28日後に最終的評価を受けた。

この試験のプライマリー・エンドポイントは臨床反応であり、これは「2012年米国感染症学会（IDSA）糖尿病性足部感染症の診断と治療のための臨床行為ガイドライン」を使って各治療医師の判断によって解消されたとされた感染と規定された。セカンダリー・エンドポイントには微生物学的成功が含まれており、これは完全な微生物学的反応と有害事象の発症とひどさと規定された。OneStep-1、OneStep-2両第3相臨床試験についての詳しい情報はhttp://www.clinicaltrials.govへ。

▽Dipexium Pharmaceuticals, Inc.について

Dipexium Pharmaceuticals, Inc.（NASDAQ: DPRX）は後期段階医薬品会社で、薬効範囲の広い新しい局所抗生物質ペプチドであるLocilex（一般名ペキシガナン・クリーム0.8%）の開発、商業化に集中している。当初、Locilexは軽度に化のうした糖尿病性足部潰瘍の治療を標的としている。また入手可能な臨床、微生物学的データのまとめに基づいて、Locilexは化のうした床ずれ、化のうしたやけど、化のうした手術の傷、メチシリン耐性黄色ブドウ球菌（MRSA）の鼻への広がりを含むその他の軽度から中程度の皮膚および皮膚組織の化のうを治療するための有望な製品候補ともみなされている。詳しい情報はhttp://www.dipexiumpharmaceuticals.comへ。

▽問い合わせ先

David P. Luci

President & Chief Executive Officer

Dipexium Pharmaceuticals, Inc.

+1-212-269-2834

info@dipexium.com;

David Garrett

Vice President, Finance & Corporate Development

Dipexium Pharmaceuticals, Inc.

+1-212-269-2834

info@dipexium.com

（C） 2016 Dipexium Pharmaceuticals, Inc. すべての権利は保有されている。

ソース：Dipexium Pharmaceuticals, Inc.

Dipexium Announces Completion of Enrollment Objective in OneStep-1 Pivotal Phase 3 Clinical Trial

PR64428

NEW YORK, May 16, 2016 /PRNewswire=KYODO JBN/ --

        -- Both Pivotal Phase 3 Clinical Trials Are Now Completed

   Dipexium Pharmaceuticals, Inc. (Nasdaq: DPRX), a late-stage pharmaceutical

company focused on the development and commercialization of Locilex(R)

(pexiganan cream 0.8%), a novel, broad-spectrum, topical antibiotic peptide,

today announced that it has completed the patient enrollment objective in the

OneStep-1 pivotal Phase 3 clinical trial in accordance with the requirements

set forth in the OneStep-1 clinical trial protocol. The Company recently

announced that it had reached the enrollment objective in the OneStep-2 pivotal

Phase 3 clinical trial in accordance with the requirements set forth in the

OneStep-2 clinical trial protocol. OneStep-1 and OneStep-2 are identical,

pivotal Phase 3 clinical trials conducted under a Special Protocol Assessment

(SPA) agreement between the U.S. Food and Drug Administration (FDA) and

Dipexium for evaluation of Locilex for the treatment of patients with mild

infections of diabetic foot ulcers (Mild DFI).

   Across both clinical trials, clinical trial sites are now in the process of

being closed, with certain trial centers continuing enrollment for

approximately 30 days to collect the required number of blood samples for

pharmacokinetic (PK) analysis as set forth in the OneStep clinical trial

protocols.

   The Company anticipates announcing top-line data from both pivotal Phase 3

clinical trials in the third quarter of 2016 and is targeting a New Drug

Application (NDA) submission with the FDA and a Marketing Authorization

Application (MAA) submission with the European Medicines Agency in the first

half of 2017.

   "We thank all our colleagues who participated in the design and

implementation of these landmark OneStep clinical trials for their support and

dedication to our new topical antibiotic development program.  We also thank

the patients who volunteered to be part of this important, ground-breaking

research study.  We can now shift our resources to compiling, analyzing and

incorporating these clinical trial results into our currently on-going parallel

New Drug Application and Marketing Authorization Application filing packages

for the US and Europe, respectively," said Robert J. DeLuccia, Executive

Chairman of Dipexium.  

   Mr. DeLuccia continued, "If these trials are successful, we anticipate that

Locilex will become the antibiotic standard of care for treatment of mild

infections of diabetic foot ulcers.  We believe it will also represent a

significant contribution to public health in view of the current worldwide

crisis of bacterial resistance and the antibiotic stewardship efforts by the

medical community to curtail the overuse of systemic antibiotics."

   OneStep-1 and OneStep-2 Trial Design

   OneStep-1 and OneStep-2 are identical, double-blind, placebo-controlled

clinical trials conducted simultaneously.  The primary objective is to

establish the clinical superiority and safety of topical Locilex plus standard

local wound care as compared to placebo cream plus standard local wound care,

in the treatment of Mild DFI.  Patients are randomized 1:1 to receive either

topical Locilex plus standard local wound care or placebo cream plus standard

local wound care for 14 days, with final evaluation at day 28.

   The primary endpoint of the trials is clinical response, which is defined as

infection resolved per the judgment of each treating physician using the 2012

Infectious Disease Society of America (IDSA) Clinical Practice Guideline for

the Diagnosis and Treatment of Diabetic Foot Infections. Secondary endpoints

include microbiological success, which is defined as complete microbiological

response, as well as the incidence and severity of adverse events. More

information about the OneStep-1 and OneStep-2 pivotal Phase 3 clinical trials

is available at: http://www.clinicaltrials.gov.

   About Dipexium Pharmaceuticals

   Dipexium Pharmaceuticals, Inc. (NASDAQ: DPRX) is a late-stage pharmaceutical

company focused on the development and commercialization of Locilex(R)

(pexiganan cream 0.8%), a novel, broad spectrum, topical antibiotic peptide.

Initially, Locilex is targeted for the treatment of mild infections of diabetic

foot ulcers. Based on a compilation of available clinical and microbiology

data, Locilex is also considered a promising product candidate to treat other

mild and moderate skin and skin structure infections, including infected

decubitus ulcers, infected burns, infected surgical wounds and nasal

colonization of methicillin-resistant staphylococcus aureus (MRSA). For more

information, visit: http://www.dipexiumpharmaceuticals.com.

   Forward-Looking Statements

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forward-looking statements within the meaning of the Private Securities

Litigation Reform Act of 1995. These forward-looking statements may include

statements relating to our anticipated clinical and regulatory development;

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   Investors should consider the information contained in our filings with the

U.S. Securities and Exchange Commission (the "SEC"), including our Annual

Report on Form 10-K, especially in the "Management's Discussion and Analysis of

Financial Condition and Results of Operations" and "Risk Factors" sections, our

most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and our

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   Company Contacts:

   David P. Luci

   President & Chief Executive Officer

   Dipexium Pharmaceuticals, Inc.

   +1-212-269-2834

   info@dipexium.com;

   David Garrett

   Vice President, Finance & Corporate Development

   Dipexium Pharmaceuticals, Inc.

   +1-212-269-2834

   info@dipexium.com

   (C) 2016 Dipexium Pharmaceuticals, Inc.  All rights reserved.

   SOURCE: Dipexium Pharmaceuticals, Inc.