ValiRx Regulatory News (VAL)

14 October 2014

ValiRx Plc

("ValiRx" or "the Company")

Approved Clinical Trial Update

Re: Progress with the Trial

("A Phase I/II, dose escalation study to assess the safety and tolerability of VAL201 in patients with locally advanced or metastatic prostate cancer and other advanced solid tumours.")

ValiRx Plc (AIM:  VAL), the life science company with a focus on cancer diagnostics and therapeutics for personalised medicine, reports that following its notification of a full approval from the Medicine and Healthcare Products Regulatory Agency ("MHRA") to conduct the above named trial, the Company, acting as sponsor, has being working with its partners and contractors to ensure that all of the required opinions, notifications and certificates that surround the approved protocol are in place, alongside the practical set up of the trial. This is now completed and all ethical opinions and other formal regulatory permissions for the continuation of the trail in to human subjects through to its completion have now been given and granted. 

The formal recruitment of subjects and the administration of the test substance can be undertaken in accordance with the approved protocol. The trial is structured in such a way that the experimental information that is collected can then be evaluated to determine whether the test substance (VAL201) is safe, and well tolerated. Further analysis of VAL201 and data from it will ascertain how the test substance is processed by the volunteer test subjects and how it is impacting upon their clinical condition. The preliminary outcomes from the first cohort are anticipated during Q1 2015.

The trial is designed as an open label, single wing study and is recruiting volunteer subjects with locally advanced or metastatic prostate cancers. The tolerability of VAL201 may then also be assessed in patients with other advanced tumour types for which no standard effective therapy is currently available, but where a rationale for the use of VAL201 exists. No healthy volunteers will be used and a range of selection parameters are in place to ensure that a representative population of patients is included.

The Company will continue to provide further information as the study progresses.

Dr Satu Vainikka, CEO of ValiRx, commented: "Following on from the MHRA's approval for the study, the team has been working hard to ensure that all of the required opinions, notifications and certificates and practical arrangements are in place. This is a key moment for any drug-discovery company and I and all at ValiRx look forward to collecting the human experimental data and updating shareholders on our results and on our continued further progress".  

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Notes for Editors

ValiRx Plc

ValiRx Plc is a biopharmaceutical company developing novel technologies and products in oncology therapeutics and diagnostics. The product focus is in the epigenomic analysis and treatment of cancer, but the technologies can be applied to other fields as well, such as neurology and inflammatory diseases.

The Company listed on AIM in October 2006 and is creating a portfolio of innovative products through investment in specific development projects. It actively manages projects within this portfolio as a trading company and is not an investment vehicle. The ValiRx business model spreads the risks of life science technology developments by minimising financial exposure and running a set of projects to defined commercial endpoints. This maximises returns to shareholders by adding value at the earlier stages where value increases per investment unit are the greatest.

The Company operates through the following divisional companies:

1. ValiFinn is the biomarkers and diagnostic development division

2. ValiPharma is the therapeutics division with two embedded technologies primarily directed at the treatment of cancers.