ValiRx Regulatory News (VAL)

1st October 2015

ValiRx Plc

("ValiRx" or "the Company")

New Japanese Patent Grant for ValiRx

 "A Cancer Biomarker Screening Test 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, announces that it has received patent approval by the Japanese 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. Identifying patients at increased risk of developing aggressive forms of B-cell lymphomas and allowing clinicians to select the most effective treatment for an individual patient. The use of biomarkers with oncology therapeutics is a fast growing areas of cancer research, as not only can biomarkers identify patients more likely to respond to a particular therapy, but also indicate tumour progression.

The grant of this latest patent to the Company means that ValiRx now has additional biomarker patent protection in Japan, Europe and Australia and USA, with further patents pending in significant markets across the rest of the world, alongside other granted and patents pending for its therapeutic technologies world wide.

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. The NAV3 analytical method allows the visualisation of the actual cancer cells.

Dr Satu Vainikka, CEO of ValiRx, commented: "The grant 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. This continues to be one of the biggest areas of application with a main emphasis on predictive and personalised medicine, but also a key, growing and essential market for early diagnosis and tumour onset.

"The patent grant also builds very nicely on our recent complementary and revenue enhancing acquisition of the TRAC technology and method, which enable the efficient screening of a large number of drug candidates for a wide range of genetic safety and efficacy markers, including VAL201 in its encouraging clinical trial".

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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 has undertaken to develop a novel and groundbreaking class of therapeutics across a number of fields in oncology and has taken its lead compound, Val201, into Phase I/II clinical trials. The Company listed on the AIM Market of the London Stock Exchange in October 2006.

The Company has a pipeline of other therapeutic drugs, which are currently progressing towards clinical trials. The product focus is in the targeted analysis and treatment of cancer, but the technologies can be applied to other fields as well, such as neurology and inflammatory diseases.

It actively manages projects within its portfolio as a trading company. The ValiRx business model spreads the risks of life science technology development 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. ValiPharma is the therapeutics division, with two embedded technologies primarily directed at the treatment of cancers.

2. ValiFinn is the biomarkers and diagnostic development division. ValiRx acquired through its ValiFinn subsidiary, the complimentary TRAC technology later in the year to strengthen the portfolio.

3. ValiSeek is a joint venture between ValiRx and Tangent Ltd to develop Val401 in lung cancer and potentially other indications.