Flagship Biosciences Provides Analytically Validated Tools to Assist in the Analysis of Summit’s 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

St. Malo, France, October, 5th, 2017 – 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.

  • 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.

About Flagship Biosciences

Flagship Biosciences helps drug developers confidently define their path to success. By leveraging our unique computational Tissue Analysis (cTA™) and Data-Driven-Decision Support Platform, we provide quantitative and contextual tissue interpretation to make timely decisions. For more information on how Flagship accelerates drug development, please visit the Company’s website: www.flagshipbio.com.

Forward Looking Statement disclaimer

Any statements in this press release about Flagship’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of product candidates, the utility of tools developed to evaluate product candidates, the therapeutic potential of product candidates, and the timing of initiation, completion and availability of data from clinical trials, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, expectations for regulatory approvals, availability of funding sufficient for Flagship’s foreseeable and unforeseeable operating expenses and capital expenditure requirements. Accordingly, readers should not place undue reliance on forward-looking statements or information. In addition, any forward-looking statements included in this press release represent Flagship’s views only as of the date of this release and should not be relied upon as representing Flagship’s views as of any subsequent date. Flagship specifically disclaims any obligation to update any forward-looking statements included in this press release.

Media Contact
Aaron Young
Marketing Associate, Flagship Biosciences, Inc.

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