ValiRx Regulatory News (VAL)

6 September 2012

ValiRx Plc

("ValiRx" or the "Company")

VAL201 Update re: Breast Cancer Study

·; VAL201 recently shown to inhibit hormone dependent breast cancer tumour growth following success at significantly inhibiting tumour cell proliferation in prostate cancer

·; VAL201's potential clinical candidate pipeline and portfolio continues to grow

ValiRx Plc (AIM: VAL), a life science company with a focus on cancer diagnostics and therapeutics for personalised medicine, is pleased to report encouraging findings following a recent early stage breast cancer study of VAL201, which showed positive inhibition of hormone dependent breast cancer tumour growth in a dose dependent manner.

This promising study follows on from ValiRx's announcement on 29 May 2012 regarding VAL201's effectiveness against prostate cancer, endometriosis and the spread of secondary cancer tumours or metastasis.

Studies have shown that the compound significantly inhibits the proliferation of aggressive tumours and that VAL201 decreases the spread and development of secondary tumours by up to 50 per cent. at projected therapeutic doses.

Patients with breast or prostate cancer typically develop metastasis or the spread of that cancer into other organs as secondary tumours and almost all patients going through the end-stage of cancer experience this proliferation of cancer cells into other organs or areas of the body. Breast cancer typically spreads to the bone and lung and liver organs.

Even if the primary tumour is successfully treated, the disease can often have spread already and treatment to combat this metastatic spread is crucial for both patient survival and quality of life.

This new indication hasshown a positive effect in the estrogen pathway in women, demonstrating good potential for the development of ovarian and breast cancer therapeutics and it builds on ValiRx's agreement with Oxford University in April 2011, to accelerate the development of VAL201. It adds to the Company's potential clinical candidate pipeline and portfolio and the results from this study are compatible with the previous findings of earlier studies.

The original patent and technology covering VAL201 is licensed by ValiRx from Cancer Research Technology ("CRT") for use in androgen resistant cancer. ValiRx has all the rights for performing pre-clinical and clinical developments and obtaining regulatory approvals in all territories. ValiRx also has full, worldwide rights and control over the commercialisation and development of potential treatments.

Breast cancer accounts for about 10% of cancers worldwide and the market size is expected to reach $11.2 billion by 2016 (BCC Research, Report code: HLC106A, June 2012).This scope therefore offers exciting and enhancing opportunities for the market expansion of novel drugs that focus on improved safety and efficacy.

ValiRx is pleased to report that it continues to further advance the regulatory filing process towards a phase I clinical trial application for VAL201 with the relevant regulatory bodies in the UK and Europe.

Dr Satu Vainikka, CEO, commented: "Tests conducted by Pharmatest, our Finnish-based research centre and biomarkers business unit, have been highly encouraging. I am delighted to see across the division that cross-marketing opportunities are already being captured. Pharmatest has extensive experience in preclinical efficacy services in the cancer field and we have every confidence in the successful progression of VAL201 towards clinical trials.

- 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

·; ValiMedix is the sales and distribution division of ValiRx

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