Publication Type Academic Article
Authors Rajagopalan S, Trachtenberg J, Mohler E, Olin J, McBride S, Pak R, Rasmussen H, Crystal R
Journal Am J Cardiol
Volume 90
Issue 5
Pagination 512-6
Date Published 09/01/2002
ISSN 0002-9149
Keywords Adenoviridae, DNA, Complementary, Endothelial Growth Factors, Genetic Vectors, Intermittent Claudication, Lymphokines, Virus Replication
Abstract The long-term safety and efficacy of adenoviral delivery of growth factors in patients with peripheral arterial disease (PAD) is unknown. CI-1023 (Ad(GV)VEGF(121.10)) is a replication-deficient adenovirus encoding human vascular endothelial growth factor isoform 121. In this phase I trial, we investigated the safety and efficacy of CI-1023 in subjects with advanced claudication symptoms secondary to infra-inguinal disease. Eighteen subjects >35 years of age with a median ankle brachial index (ABI) at rest of 0.525 (interquartile range 0.4) and angiographic disease involving the infra-inguinal vessels underwent intramuscular injection of CI-1023 (4 x10(8) to 4 x10(10) particle units, n = 15) or placebo (n = 3). Eleven of 15 patients (73%) who received CI-1023 and 1 of 3 subjects (33%) who received placebo, completed 1 year of follow-up. Edema and rash were the most common early adverse event. One infra-inguinal bypass procedure occurred in each of the placebo and CI-1023 groups at days 29 and 104, respectively. One death (day 160) and 1 malignancy (day 274) occurred in the CI-1023 group. Conclusions on efficacy could not be made due to the small number of patients. However, there were encouraging trends in ABI at rest and peak walking time at follow-up.
DOI 10.1016/s0002-9149(02)02524-9
PubMed ID 12208412
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