Valirx Regulatory News (VAL)

29 May 2012

ValiRx Plc

("ValiRx" or the "Company")

Update re: Late Pre-clinical Study of VAL201

·      VAL201 shown to significantly inhibit aggressive tumour cell proliferation in prostate cancer

·      Reduce the spread of secondary tumours by up to 50 per cent

·      Regulatory data generation and process continues as predicted

ValiRx Plc (AIM: VAL), a life science company with a focus on cancer diagnostics and therapeutics for personalised medicine, is pleased to report significant and substantively important findings from its independently conducted late pre-clinical studiesinto the development of VAL201, one of its lead therapeutics, in the acquisition of good pre-clinical and the required regulatory data for the compound's use in humans.

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.

These findings represent a major step forward as they independently confirm and extend earlier studies undertaken by the Company. Patients with 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. 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.

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 rights to perform 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.

The latest studies havealso shown a positive effect in the estrogen pathway in women, thereby providing good potential for the development of ovarian and breast cancer therapeutics. This work builds on ValiRx's agreement with Oxford University in April 2011, to accelerate the development of VAL201 and to study its therapeutic potential for additional indications.

The compound has already shown efficacy as a potential treatment against endometriosis or hormone induced abnormal cell growth in women. Based on results in endometrial models, VAL201 has been shown to reduce the abnormal endometrial growth, whilst leaving other hormone-induced activities working normally. ValiRx announced on 3 November 2011 that it had filed a new patent regarding this indication.

It has been predicted that the global endometriosis market will reach $1.3billion by 2017 and endometriosis remains a common health problem among women, with an estimated 170 million sufferers globally. This estimate is widely considered to be an under estimation of the true situation with respect to this condition. Predictions for the prostate cancer market say that it is set to expand to $5 billion by 2015 due to the growing prostate cancer population (that is a 25% growth from 2010 to 2020)

The Company has commenced acute and chronic regulatory toxicology studies. No significant toxicology effects have been seen to date at levels well above the expected therapeutic dosing levels. However, the studies are not complete. ValiRx is also happy to announce that the compound demonstrates good stability in storage to date. Further work on the behaviour of the compound with respect to other required regulatory matters have yet to be completed.

ValiRx is pleased to report that it has started 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: "I am absolutely thrilled by these latest findings for VAL201.  We knew from previous studies last year that the compound was showing effect at preventing proliferative tissue growth in live studies and with reduced side effects. With this data and the fact that we can now curtail and even substantially reduce cancerous growth, a treatment for this horrible disease, which affects many millions across the globe, is tantalisingly closer.

"With production of VAL201 now being human compliant and with a larger data set to work from, we are increasingly developing a much better understanding of the nature of the compound and how VAL201 specifically interacts biologically and impacts on disease progression. I very much look forward to VAL201's imminent move into clinical trials and, by extension, its potential being realised to both save and improve lives."

- 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:

·      ? 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.