June 2017
Volume 58, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2017
Phase 1 safety and tolerability assessment of ANX776 in DARC (Detection of Apoptosing Retinal Cells) Technology
Author Affiliations & Notes
  • M Francesca Cordeiro
    Glaucoma & Retinal Neurodegnrtn Res Grp, UCL Inst Ophthal & Western Eye Hsp London, London, United Kingdom
    Imperial College London, ICORG, London, London, United Kingdom
  • Eduardo Maria Normando
    Glaucoma & Retinal Neurodegnrtn Res Grp, UCL Inst Ophthal & Western Eye Hsp London, London, United Kingdom
    Imperial College London, ICORG, London, London, United Kingdom
  • M. Jorge Cardoso
    Translational Imaging Group, Centre for Medical Image Computing, UCL, London, United Kingdom
  • Serge Miodragovic
    Imperial College London, ICORG, London, London, United Kingdom
    Western Eye Hospital, London, United Kingdom
  • Seham Jeylani
    Imperial College London, ICORG, London, London, United Kingdom
    Western Eye Hospital, London, United Kingdom
  • Benjamin Davis
    Glaucoma & Retinal Neurodegnrtn Res Grp, UCL Inst Ophthal & Western Eye Hsp London, London, United Kingdom
  • Li Guo
    Glaucoma & Retinal Neurodegnrtn Res Grp, UCL Inst Ophthal & Western Eye Hsp London, London, United Kingdom
  • Sebastien Ourselin
    Translational Imaging Group, Centre for Medical Image Computing, UCL, London, United Kingdom
  • roger A'Herne
    81 Hillier Road Battersea, London, United Kingdom
  • Philip A Bloom
    Western Eye Hospital, London, United Kingdom
    Imperial College London, ICORG, London, London, United Kingdom
  • Footnotes
    Commercial Relationships   M Francesca Cordeiro, UCL Business (P); Eduardo Normando, None; M. Jorge Cardoso, None; Serge Miodragovic, None; Seham Jeylani, None; Benjamin Davis, None; Li Guo, None; Sebastien Ourselin, None; roger A'Herne, None; Philip Bloom, None
  • Footnotes
    Support  The Wellcome Trust WT099729
Investigative Ophthalmology & Visual Science June 2017, Vol.58, 215. doi:
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    • Get Citation

      M Francesca Cordeiro, Eduardo Maria Normando, M. Jorge Cardoso, Serge Miodragovic, Seham Jeylani, Benjamin Davis, Li Guo, Sebastien Ourselin, roger A'Herne, Philip A Bloom; Phase 1 safety and tolerability assessment of ANX776 in DARC (Detection of Apoptosing Retinal Cells) Technology. Invest. Ophthalmol. Vis. Sci. 2017;58(8):215.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : We have previously demonstrated experimentally the use of a new fluorescent –labelled annexin 5 (ANX776) to detect apoptosing cells in the retina (DARC - Detection of Apoptosing Retinal Cells), and have investigated ANX776 in different experimental models of retinal neurodegeneratiom. Here we report the safety and tolerability of intravenous ANX776 in a Phase 1 study.

Methods : 8 healthy and 8 glaucoma subjects were treated in four ascending-dose cohorts (n=4 per cohort) in which participants were randomly assigned to receive a single intravenous injection of ANX776 (0.1, 0.2, 0.4 or 0.5 mg).

Results : ANX776 was found to demonstrate favourable safety, tolerability, and pharmacokinetic profiles at all doses tested. No serious adverse events (defined as Grade 3 or above by the CTCAE - common terminology criteria for adverse events), discontinuations as a result of adverse events, or dose-limiting toxicities were reported. Pharmacokinetics confirmed that ANX776 had a short half-life inversely proportional to the dose administered, ranging from 10-36 minutes.

Conclusions : This study demonstrates that intravenous ANX776 is safe to use in humans. These findings support continued development of ANX776, including further characterization of its efficacy, safety, tolerability and pharmacodynamic effects in patients with neurodegenerative conditions

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.

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