ValiRx Regulatory News (VAL)

3 November 2011

ValiRx Plc

("ValiRx" or the "Company")

New Patent Filing for Lead Therapeutic Compound VAL201

"ValiRx files new patent for additional indication in endometriosis or hormone induced abnormal cell growth in women"

"Studies show VAL201 reduces the abnormal endometrial growth, whilst preserving fertility"

ValiRx Plc (AIM: VAL), a life science company with a focus on cancer diagnostics and therapeutics for personalised medicine, is pleased to announce that it has filed a new patent regarding its lead therapeutic compound VAL201 for a further indication in 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. This suggests that VAL201 has potential for reducing side effects as indicated in an earlier study of VAL201 with respect to prostate cancer in men (28 July 2011).

The latest findings expand the potential use of VAL201 in therapeutics to another area of significant unmet medical need and builds on ValiRx's continuing progress with VAL201, in collaboration with Oxford University and others, in the development of good pre-clinical and required regulatory data for the compound's use against prostate cancer in men.

Endometriosis is a gynaecological medical condition in which cells from the lining of the uterus (endometrium) appear and flourish outside the uterine cavity, most commonly on the ovaries. The uterine cavity is lined by endometrial cells, which are under the influence of female hormones. These endometrial-like cells in areas outside the uterus (endometriosis) are influenced by hormonal changes and respond in a way that is similar to the cells found inside the uterus. Symptoms often worsen with the menstrual cycle. Endometriosis is excessively debilitating, typically seen during the reproductive years and represents one of the major causes of female infertility.

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.

The original patent and technology covering VAL201 is licensed by ValiRx from Cancer Research Technology ("CRT") for use in androgen resistant cancer. The two major cancers of this type are prostate and breast cancer, the more common being prostate cancer. Under the terms of the licence with CRT, ValiRx is responsible for performing the pre-clinical development and obtaining regulatory approval to take the compound into clinical trials in patients. ValiRx will also manage the commercialisation and development of potential treatments.

ValiRx continues VAL201's preclinical development programmes in prostate cancer and endometriosis and looks forward to developing the compound to the stage where it meets with the regulatory requirements in preparation for entering clinical trials.

Dr Satu Vainikka, CEO, commented: "I am delighted with the progress we are seeing and the filing of this latest patent is an exciting next step in the development of the compound.

The market for treatments against endometriosis and hormone induced tumour growth is substantial and with significant unmet clinical need. I am pleased therefore to see that novel therapeutics with improved safety profiles and with minimal side effects are increasingly addressing these conditions. Several major pharmaceutical companies have already expressed considerable interest in endometriosis therapeutics and I believe new methods of treatment are increasingly being accepted. I very much look forward to the continued development of VAL201 for the benefit of all parties".

- 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. Of particular note is GeneICE, ValiRx's technology for controlling rebellious genes, which was awarded a Eurostars grant to the value of €1.2 million to fund the development of the GeneICE products through preclinical stages in cancer treatments

Background to GeneICE & Eurostars

In June 2009, ValiRx, as the leading partner of an international consortium of three companies, was awarded a two year grant by Eurostar against substantial competition from across Europe, to develop its GeneICE technology ("GeneICE" or "Gene inactivation by chromatin engineering"), in which "rebellious genes", which cause problems such as cancer and potentially some neurological problems, are shut down or "put on ice".

The Eurostars programme is a EU grant scheme and EUrEKa Network initiative, created with the purpose of providing funding for market-oriented research and development activities by Small and Medium-sized Enterprises within the EU.

ValiRx successfully led the funding application with GenoSyst (Finland) and PentaBase (Denmark) under the 2nd call to the Eurostars joint Programme, for design optimisation, lead selection and pre-clinical testing of GeneICE. The application was rated second in the UK and Finland and first in Denmark, coming in 4th overall out of over 500 applicants within the EU wide scheme.

The technology is under license from Imperial College, University of London and it has been shown to be effective against several cancer cell lines, including prostate cancer, ovarian cancer, pancreatic cancer and lung cancer. ValiRx retains all commercial rights for GeneICE from the programme.

The GeneICE development plan has four principal goals:

1. Identification of specific genomic DNA sequences associated with proven cancer targets.

2. Design and optimisation of the anti-gene system to silence the aberrant genes

3. Evaluation of desired and potential off-target effects

4. Pre-clinical development of an optimised lead therapeutic against a selected target