Norgine B.V.



AsiaNet 58126 (1089)


Logo: http://photos.prnewswire.com/prnh/20130829/633895-a




リリースの全文はhttp://www.norgine.com を参照。

(注)「Optimizing Adequacy of Bowel Cleansing for Colonoscopy: Recommendations From the US Multi-Society Task Force on Colorectal Cancer(大腸内視鏡向け腸管洗浄の妥当性を最適化する:大腸がんに関する米 Multi-Society Task Forceの提言」。米消化器学会、米消化器内視鏡学会の共同ガイドライン。The American Journal of Gastroenterology(米消化器学会誌)から引用。

Charlotte Andrews
Tel: +44(0)1895-453669

Isabelle Jouin
Tel: +44(0)1895-453643

ソース:Norgine B.V.


Norgine Enrols First Patient in the Phase III NOCT Study to Evaluate Bowel Cleansing Efficacy of NER1006, a Novel, Low Volume Bowel Preparation, vs. Trisulfate

LONDON, Oct, 3. 2014 /PRN=KYODO JBN/ —

    Norgine today announced the enrolment of the first patient into the US
Phase III study, NOCT, for its investigational product NER1006. This study will
evaluate the bowel cleansing efficacy of a two-day split-dosing regimen of
NER1006, versus a split-dosing regimen of a trisulfate bowel cleansing solution
(SUPREP(R)) in adult patients undergoing screening, surveillance or diagnostic
colonoscopy. The NOCT study will also assess the compliance, safety, patient
acceptability and tolerability of NER1006.

    (Logo: http://photos.prnewswire.com/prnh/20130829/633895-a )

    NER1006 is a novel, low volume polyethylene glycol based bowel preparation
that has been developed to provide whole bowel cleansing, with an additional
focus on the ascending colon. The dosing regimen of NER1006 (32 fl oz, of bowel
preparation solution with 32 fl oz of extra water or clear fluid) aims to
deliver a high level of efficacy. This low volume solution should not only
support improved patient acceptability and compliance but also to contribute to
effectiveness of colonoscopy procedures at detecting colon cancer and for
optimised bowel surveillance, through effective bowel cleansing.[i]

    The NOCT study is part of Norgine’s NER1006 Phase III clinical trials
programme. NOCT is a US multicentre, randomised, parallel-group clinical trial
that is expected to enrol 540 patients across two arms. The Phase III programme
also includes two clinical studies in Europe further investigating the bowel
cleansing efficacy, compliance, safety, patient acceptability and tolerability
of NER1006. The MORA study will compare NER1006 versus MOVIPREP(R) using a
2-day split-doing regimen and a 1-day morning split-dosing regimen in adults.
The DAYB study will compare NER1006 versus a sodium picosulfate and magnesium
solution (CITRAFLEET(R)) using a day before only dosing regimen in adults.
Enrolment for trials MORA and DAYB are planned to start in late 2014.

    Donna McVey, Chief Development Officer, Norgine, commented: "We are excited
about the clinical progress being made with NER1006, further strengthening our
bowel cleansing portfolio which also includes MOVIPREP(R) and KLEAN-PREP(R).
The acceptability of effective bowel cleansing products is critical for
patients to ensure quality colonoscopy and avoid the need for repeat

    See full release on http://www.norgine.com

    [i] Optimizing Adequacy of Bowel Cleansing for Colonoscopy: Recommendations
From the US Multi-Society Task Force on Colorectal Cancer. A joint guideline
from the American Gastroenterological Association, and American Society for
Gastrointestinal Endoscopy. The American Journal of Gastroenterology. 2014

    Charlotte Andrews: Tel: +44(0)1895-453669

    Isabelle Jouin: Tel: +44(0)1895-453643

    SOURCE: Norgine B.V.