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

doi:10.1080/15569520701212167

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

Neuroscience

Research output: Contribution to journal › Article › peer-review

8 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 language	English (US)
Pages (from-to)	83-105
Number of pages	23
Journal	Cutaneous and Ocular Toxicology
Volume	26
Issue number	2
DOIs	https://doi.org/10.1080/15569520701212167
State	Published - Apr 2007

Keywords

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

ASJC Scopus subject areas

Toxicology

Access to Document

10.1080/15569520701212167

Cite this

Veneziale, R. W., Bral, C. M., Sinha, D. P., Watkins, R. W., Cartwright, M. E., Rosenblum, I. Y., Treinen, K. A., Kishnani, N. S., Nelson, J., Chen, Z., Faha, B., Maneval, D., Munger, R. J., Cai, X. Y., Cullen, C., & Arezzo, J. C. (2007). SCH 412499: Biodistribution and safety of an adenovirus containing P21 ^WAF-1/CIP-1 following subconjunctival injection in cynomolgus monkeys. Cutaneous and Ocular Toxicology, 26(2), 83-105. https://doi.org/10.1080/15569520701212167

Veneziale, RW, Bral, CM, Sinha, DP, Watkins, RW, Cartwright, ME, Rosenblum, IY, Treinen, KA, Kishnani, NS, Nelson, J, Chen, Z, Faha, B, Maneval, D, Munger, RJ, Cai, XY, Cullen, C & Arezzo, JC 2007, 'SCH 412499: Biodistribution and safety of an adenovirus containing P21 ^WAF-1/CIP-1 following subconjunctival injection in cynomolgus monkeys', Cutaneous and Ocular Toxicology, vol. 26, no. 2, pp. 83-105. https://doi.org/10.1080/15569520701212167

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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.",

keywords = "Adenovirus, Choroid, Fistula patency, Gene therapy, Glaucoma, Inflammation, Monkey, P21, Subconjunctival injection, Toxicity, Trabeculectomy, Wound healing",

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

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AU - Watkins, Robert W.

AU - Cartwright, Mark E.

AU - Rosenblum, Irwin Y.

AU - Treinen, Kimberley A.

AU - Kishnani, Narendra S.

AU - Nelson, Joyce

AU - Chen, Zoe

AU - Faha, Barbara

AU - Maneval, D.

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