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Flagship Biosciences Provides Analytically Validated Tools to Assist in the Analysis of Summits PhaseOut DMD Clinical Trial

CLSI compliant analytically validated cTA™ tools for 2 duplex IHC assays presented at the 22nd annual meeting of the World Muscle Society

Flagship Biosciences, Inc., the leading developer of quantitative tissue biomarker interpretations for clinical development of tissue-based diagnostics to drive clinical decisions for industry partners, presented today 2 analytically validated duplex IHC assays developed for Summit Therapeutics’ PhaseOut DMD Phase 2 clinical trial at the annual meeting of the World Muscle Society, October 3rd to 7th. Flagship and Summit have collaborated to develop a biomarker analysis process using Flagship’s cTA™ platform, enabling precise muscle fiber biomarker quantification across entire muscle biopsy sections. Summit aims to treat DMD by modulating utrophin, a structural protein expressed in developing and regenerating muscle fibers, to substitute for dystrophin. Analytical validation of the biomarker analysis method was done in compliance with CLSI (Clinical & Laboratory Standards Institute) guidelines to establish a method for precise and accurate evaluation of muscle biopsy samples.

“We developed and analytically validated cTA™ tools in support of efficacy evaluations of ezutromid in Summit’s ongoing phase two clinical trial, PhaseOut DMD, and are proud to create novel approaches supporting clinical trials in the muscle disease space” said Dr. C. Faelan, lead scientist at Flagship Biosciences on their collaboration with Summit. Adding, “We know how valuable muscle biopsies are and we know the importance of being able to get as much data out of them as possible. Our tools allow for the comprehensive evaluation of molecular and cellular characteristics of skeletal muscle regeneration.”

Two posters presented at the 22nd World Muscle Society (WMS) meeting detail developments in the creation of the image analysis software and the validation of the duplex assay that will allow researchers to determine to what extent treatment with ezutromid has affected utrophin and muscle regeneration. A third poster presented by Summit at the meeting outlines the process and implementation of biopsy collection and preparation for the PhaseOut DMD trial. Attendees of the WMS meeting are encouraged to see the poster presentations and learn about these critical developments in DMD research.

Poster details:

Thursday 5 October 2017, 5pm – 6:30pm

  • Poster #P.392
  • Title: Analytical Validation (Based on CLIA & CLSI Standards) of Utrophin-laminin
  • α2 and MHCd-laminin α2 Duplex Immunohistochemical Assays using Computational Tissue Analysis (cTA™) for Evaluation of Duchenne Muscular Dystrophy Therapeutics

Thursday 5 October 2017, 5pm – 6:30pm

  • Poster #P.393
  • Title: Computational Alignment of Duplex Immunohistochemically-Stained Muscle Sections in Support of Therapies for Duchenne Muscular Dystrophy

Thursday 5 October 2017, 5pm – 6:30pm

  • Poster #P.469
  • Title: Collection of high quality muscle biopsies for use in DMD clinical trial analysis; process development and implementation

“We proudly support Summit’s critical work towards a DMD therapy applicable to all patients with DMD with our advanced tissue analysis solutions. The progress we have made in developing these tools could progress the deep understanding of how patients are responding to treatment in this challenging rare disease space” commented Dr. David Young, CEO of Flagship.



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