SCH 412499: biodistribution and safety of an adenovirus containing P21(WAF-1/CIP-1) following subconjunctival injection in Cynomolgus monkeys.

作者信息

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

机构信息

Drug Safety, Schering-Plough Research Institute. Lafayette, New Jersey 07848-0032, USA.

出版信息

Cutan Ocul Toxicol. 2007;26(2):83-105. doi: 10.1080/15569520701212167.

DOI:10.1080/15569520701212167

PMID:17612977

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.

摘要