ValiRx Regulatory News (VAL)

11 February 2015

ValiRx Plc

("ValiRx" or "the Company")

New European  Patent  Grant  for  ValiRx

 "A Cancer Biomarker ScreeningTest for Diagnostics of B-cell Lymphomas based on NAV3"

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 received patent approval by the European Patent Office covering the means for diagnosing and monitoring of patients using biomarker testing for B-cell lymphomas and its prognostic outcome.

The Patent is based around the NAV3 gene and comprises a novel method to permit early diagnosis by use of the biomarker for diagnosing and separating types of B-cell lymphomas into different prognostic groups. This method thereby, assists in the identification of patients at increased risk of developing aggressive forms of B-cell lymphomas and it permits clinicians to select those therapies which are most effective in an individual patient.

The granting of this latest patent to the Company means that ValiRx now has additional biomarker patent protection in Japan, Europe and Australia and elsewhere , with further patents pending in the US and other territories, alongside other granted and patents pending for its therapeutic technologies world wide.

The use of biomarkers with oncology therapeutics is one of the fastest growing areas of cancer research, as not only can the biomarkers identify patients who are more likely to respond to a particular drug therapy, but they can also indicate tumour progression.

The NAV3 gene biomarker can be used in a number of ways. It can detect pre-malignant cells at the stage where tumour development is only about to start and it also forms a highly sensitive and specific test for finding cancer cells in tissue or samples, such that the tracking of only a few malignant cells or the examination of various samples and biopsy types is possible.

In cancer diagnostics, the detection of malignant cells as early as possible is a key challenge. Early detection can often have a significant impact on the future survival of cancer patients. The current diagnostic methods for cancer rely mainly on the microscopic analysis of cells in biopsies, however, at the early stage of cancer and before morphological changes have developed, such malignant cell detection is and remains difficult.

Dr Satu Vainikka, CEO of ValiRx, commented: "The granting of this latest patent not only further extends our global geographic patent coverage, but it continues to endorse the Board's decision to establish ValiFinn and our Finnish biomarkers business to capitalise on the increasingly fast use of biomarkers in oncology therapeutics, which is one of the biggest application areas with a main emphasis on predictive and personalised medicine."

"The patent grant also builds very nicely on our recent complementary and revenue enhancing acquisition of the TRAC technology and method, which was originally in development for over 10 years at VTT (Finnish State Research Centre) and enables the efficient screening of a large number of drug candidates for a wide range of genetic safety and efficacy markers".

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Notes for Editors

Background on Biomarkers (Sources: BCC Research and researchandmarkets 2010/2011)

Biomarkers in Cancer Research 2010 stated that the use of Biomarkers in Oncology Therapeutics is one of the biggest application areas with main emphasis on predictive and personalised medicine.

The global cancer biomarkers market for 2007 was estimated to be $3.6 billion and is expected to grow at a CAGR (Compounded Annual Growth Rate) of 6.3% to reach $6.3 billion by 2016. This growth is primarily attributed to the rise in the number of biomarker tests in a wide variety of cancer types.

In the future, the growth of personalized medicines and the strong support from regulatory agencies such as the FDA will be the two major factors that will drive the demand for biomarkers, particularly in cancer research.

Personalised medicines are gaining popularity due to their ability to provide customised treatment to patients based on their genetic as well as medical profile. Since biomarkers help in predicting patient response to a compound, personalised medicine is increasingly using biomarkers to identify the patient population set that is more likely to respond to a particular drug therapy. Personalised medicines are also increasingly being used in targeted cancer therapies. Thus, going forward, as personalised medicines gain more importance and popularity, the demand for biomarkers is also expected to increase.

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.