Clinical Trials

PsiOxus intends to develop treatments for patients around the world and conducts clinical trials on an international basis in support of this aim. We are committed to furthering medical and scientific knowledge, and to achieve this we conduct our clinical trials to the highest possible standards to meet our ethical, legal and regulatory obligations. We believe in ensuring that our clinical trial information and emerging data are made available in a timely manner. Below are brief details of our clinical trials with links to results and data where available. The links to clinicaltrials.gov give further details of each clinical trial including any ongoing recruitment, inclusion and exclusion criteria and the investigator sites involved.

SPICE Study

The SPICE Study (Study of PD-1 Inhibition in Combination with Enadenotucirev) is a clinical trial partnership between PsiOxus Therapeutics and Bristol-Myers Squibb.

This is a Phase I multicenter, open label, nonrandomized study of enadenotucirev administered in combination with nivolumab in subjects with metastatic or advanced epithelial tumors (with a focus on Non-Small Cell Lung, Colorectal Cancer, Urothelial Cancer, and Squamous Cell Cancer of the Head and Neck) not responding to standard therapy.

This study is currently recruiting patients in the USA.

For more information about this trial and participating centres, view clinicaltrials.gov

 

The EVOLVE Study

The Evolve (Evaluating Oncolytic Vaccine Efficacy) clinical study (ColoAd1-1001) is a first in human non-randomised multicentre phase I study to assess the safety, tolerability and potential efficacy of enadenotucirev delivered intravenously.

This study is closed for recruitment.

For more information about this trial, please follow these links:

ClinicalTrials.Gov
Poster presentation from ESMO 2014

 

The OCTAVE Study

The Octave (ColoAd1-2001) study is a phase I/II non-randomised multicentre, study of enadenotucirev administered intraperitoneally (IP) to patients with platinum-resistant epithelial ovarian cancer.

The main objective of the phase I part of the study is to determine the dose of enadenotucirev to be used for further studies, either alone or in combination with paclitaxel administered weekly intravenously.

The phase II part of the study aims to determine whether intraperitoneal enadenotucirev has a risk benefit profile that supports further investigation in the treatment of patients with platinum-resistant epithelial ovarian cancer.

This trial is currently recruiting subjects in the UK and Spain.

For more information about this trial and the participating centres, please follow these links:

ClinicalTrial.Gov
CancerResearchUK.Org

The MECHANISM OF ACTION Study

The Mechanism of Action (ColoAd1-1002) study is a non-randomised phase I study to assess the pattern of delivery of enadenotucirev and the associated inflammatory immune response within epithelial solid tumour tissue after intra-tumoural injection or intravenous infusion in patients who are candidates for resection of their primary tumour.

This study is closed for recruitment.

For more information about this trial, please follow these links:

ClinicalTrial.Gov
Poster presentation from ESMO 2014

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