PsiOxus begins OCTAVE study.
M2 PHARMA-June 19, 2014-PsiOxus begins OCTAVE study
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PsiOxus Therapeutics, an Oxford, UK-based company that develops therapeutics for serious diseases with a particular focus on cancer, has announced via its website the first dosing of a patient in the OCTAVE (Ovarian Cancer Treated with Adeno Vaccine Enadenotucirev) study.
Scheduled to begin this month at multiple UK cancer centres, OCTAVE is a phase I/II clinical trial to assess the safety and efficacy of the company's oncolytic vaccine enadenotucirev (previously known as ColoAd1) in platinum-resistant ovarian cancer patients.
Enadenotucirev is claimed to have shown potent, broad-spectrum, anti-cancer activity pre-clinically and is also in phase I/II clinical trials in patients with colorectal tumours.
The OCTAVE 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.
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