ValiRx Regulatory News (VAL)

13 June 2013

ValiRx Plc

("ValiRx" or the "Company")

Re: VAL201 Update

ValiRx Plc (AIM: VAL), a life science company with a focus on cancer therapeutics for personalised medicine, is pleased to announce an update relating to the recent progress of its lead therapeutic compound and its clinical progression and development.

VAL201

VAL201, ValiRx's leading anti-cancer therapeutic, which is in the clinical development phase for prostate cancer among other indications, has seen continued good progress undertaking the steps required in the development of its anti-cancer drug.

An expanded and adaptive clinical protocol for the first-in-man studies has been agreed with all the relevant parties. The protocol covers all stages of clinical development from before the compound's introduction to the test subject through the evaluation of tolerability and safety into the early assessment of efficacy, and subject to review will permit the compound to move efficiently into later phase 2 efficacy studies. The protocol also opens the possibility of widening the scope of the study from the initial prostate cancer indication based on the results obtained.

With this expanded vision of the trial protocol, various enhancements to the toxicology package have been undertaken and are reaching their conclusion. No significant adverse events have been reported to date and the first-in-man trial is expected to provide results by the year-end, as previously reported.

In addition, the Institut Paoli-Calmettes in France has provisionally agreed to conduct further efficacy studies and undertake clinical studies on the use of VAL201 in additional oncological indications.

In support of this, the clinical GMP manufacturing process has been optimised so as to provide material of suitable quality and quantity and at reasonable cost, to cover all possible trials and in compliance with all regulatory requirements throughout the whole process to potential registration.

The Company has also agreed specific insurance cover for the trials and this has been approved.

Biomarkers

The biomarker work associated with VAL201 trials has provided its first positive results and ValiRx's laboratory in Finland is now appropriately equipped and staffed to undertake the necessary work in support of the rest of the clinical studies programme.

European Medicines Agency

ValiRx is also pleased to report that the European Medicines Agency has confirmed that the Company is eligible to benefit from its administrative and financial assistance to small or medium sized enterprises. As a result, ValiRx qualifies for a substantial discount of the fees associated with many of its activities, which can be in the range of 90-100% depending on the activity. This is of particular importance to Valirx given the nature of its therapeutic products and the indications at which they are aimed.

Dr Satu Vainikka, Chief Executive, commented:

"I am delighted with the progress of our development compound VAL201 and I look forward to seeing the benefit of our approach, which is designed to secure an enhanced value for the Company's oncological portfolio of development programmes".

- ENDS -

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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:

ValiFinn is the biomarkers and diagnostic development division

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