Clinical Trials with Oncolytic Adenovirus in China

Abstract

Since the 1990s, oncolytic viruses were utilized to treat cancer patients from phase I to phase III. Oncolytic virus development in China has been keeping in step with that in other countries and even accelerated the process in some fields, especially in conducting clinical trials. H101 is one kind of oncolytic adenovirus with E1B-55KD and partial E3 deleted developed by Shanghai Sunwaybio. From 2000-2004, phase I to phase III clinical trials for treating head and neck cancer were conducted in China. Clinical data show that H101 is well tolerable and has good efficacy when combined with chemotherapy in some cancer treatment modalities. We review the clinical results and relative issues of H101 in treating cancer and discuss approaches and possible improvements for the future. Information on other oncolytic viruses developing in China is also provided.

A phase I trial of intratumoral administration of recombinant oncolytic adenovirus overexpressing HSP70 in advanced solid tumor patients

“…5 To date, more than 600 cancer patients have safely received intratumoral treatment with H101 during clinical trials (phase I through to phase III). 6 In H101 clinical trials, we noticed that the patients with fever after H101 intratumoral injection tended to show higher tumor regression response rates, not only in the locally injected tumor but also in the uninjected distant masses, than the treated patients without fever. 7 One of the best-characterized biological responses to fever is the induction of heat shock protein (HSP) expression.…”

An ex vivo loop system models the toxicity and efficacy of PEGylated and unmodified adenovirus serotype 5 in whole human blood

“…[1][2][3] Oncolytic Ad5 viruses have been used in numerous clinical phase I and II studies in the US and China. [4][5][6][7][8][9] There are two commercialized adenoviruses for treatment of cancer in China, one adenoviral vector expressing p53 and one E1B 55K-deleted replication-competent adenovirus. 10,11 Intratumoral injections have in some cases led to successful results.…”

Changing the adenovirus fiber for retaining gene delivery efficacy in the presence of neutralizing antibodies

“…[1][2][3] Heretofore, patient safety has been excellent in cancer trials. Furthermore, even early generation, relatively attenuated agents have provided single-agent tumor responses 4,5 or improved response rates in randomized combination regimens.…”