Date: 2014-06-17
Type of information: Initiation of the trial
phase: 2-3
Announcement: dosing of the first patient
Company: PsiOxus Therapeutics (UK)
Product: enadenotucirev (previously known as ColoAd1)
Action
mechanism: immunotherapy product/oncolytic virus. Enadenotucirev is a chimeric oncolytic vaccine. It is currently undergoing phase I/II testing in platinum-resistant ovarian cancer patients across multiple UK cancer centres. The OCTAVE (Ovarian Cancer Treated with Adeno Vaccine Enadenotucirev) phase I/II clinical trial aims to assess the safety and efficacy of PsiOxus’ novel oncolytic vaccine. Enadenotucirev is also under investigation in two further European clinical studies in patients with colorectal cancer, bladder cancer, non small cell lung cancer and renal cancer.
Disease: platinum-resistant ovarian cancer
Therapeutic area: Cancer - Oncology
Country: Spain, UK
Trial
details: OCTAVE is a phase I/II clinical trial to assess the safety and efficacy of the oncolytic vaccine enadenotucirev (previously known as ColoAd1) in platinum-resistant ovarian cancer patients at multiple UK cancer centres. The study will examine the safety, tolerability, pharmacokinetics and efficacy of administering the vaccine directly into the abdomen of cancer patients, where ovarian cancer tends to recur (a process known as intra-peritoneal or IP delivery). The phase I component of the study will determine the dose of enadenotucirev to be used alone or in combination with paclitaxel. The phase II component will be an open label dose expansion of the combination regimen of enadenotucirev and paclitaxel to determine whether this combination has a risk benefit profile that supports further investigation in the treatment of patients with platinum-resistant epithelial ovarian cancer. (NCT02028117)
Latest
news: * On June 17, 2014, PsiOxus Therapeutics announced the first dosing of a patient in the OCTAVE (Ovarian Cancer Treated with Adeno Vaccine Enadenotucirev) study. OCTAVE is a phase I/II clinical trial to assess the safety and efficacy of its oncolytic vaccine enadenotucirev (previously known as ColoAd1) in platinum-resistant ovarian cancer patients at multiple UK cancer centres beginning this month.
