SCH 412499: Biodistribution and safety of an adenovirus containing P21 WAF-1/CIP-1 following subconjunctival injection in cynomolgus monkeys

Robert W. Veneziale, Christopher M. Bral, Dinesh P. Sinha, Robert W. Watkins, Mark E. Cartwright, Irwin Y. Rosenblum, Kimberley A. Treinen, Narendra S. Kishnani, Joyce Nelson, Zoe Chen, Barbara Faha, D. Maneval, Robert J. Munger, Xiao Yan Cai, Constance Cullen, Joseph C. Arezzo

Research output: Contribution to journalArticlepeer-review

7 Scopus citations

Abstract

Monkey studies were conducted for the preclinical safety assessment of SCH 412499, an adenovirus encoding p21, administered by subconjunctival injection prior to trabeculectomy for postoperative maintenance of the surgical opening. Biodistribution of SCH 412499 was minimal and there was no systemic toxicity. Findings included swollen, partially closed or shut eye(s) and transient congestion in the conjunctiva. A mononuclear cell infiltrate was present in the conjunctiva, choroid and other ocular tissues, but completely or partially resolved over time. Electroretinograms and visual evoked potentials revealed no adverse findings. Thus, the findings are not expected to preclude the clinical investigation of SCH 412499.

Original languageEnglish (US)
Pages (from-to)83-105
Number of pages23
JournalCutaneous and Ocular Toxicology
Volume26
Issue number2
DOIs
StatePublished - Apr 1 2007

Keywords

  • Adenovirus
  • Choroid
  • Fistula patency
  • Gene therapy
  • Glaucoma
  • Inflammation
  • Monkey
  • P21
  • Subconjunctival injection
  • Toxicity
  • Trabeculectomy
  • Wound healing

ASJC Scopus subject areas

  • Toxicology

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