ValiRx Regulatory News (VAL)

28 November 2013

ValiRx Plc

("ValiRx" or the "Company")

Update re Positive VAL201 & Biomarker Unit Studies

ValiRx Plc (AIM: VAL), a life science company with a focus on cancer therapeutics for personalised medicine, is pleased to announce that it has received encouraging and positive reports from the Group's laboratory and biomarker unit, ValiFinn, in Finland, on the integral biomarker work associated with VAL201's First in man trial, ValiRx's leading anti-cancer therapeutic compound, which currently is in the clinical development phase for prostate and other hormone induced cancer indications.

Two full reports have been provided on VAL201, from Finnish Government supported studies conducted at ValiFinn.

From these reports and in confirmation of previous proof of concept studies, VAL201 demonstrated a reducing effect on both hormone dependent and independent prostate cancer cells. The study investigated the diagnostic capability and the efficacy of the biomarkers for assessing the proliferation of cancer cells and measured levels of PSA, the usual prostate cancer diagnostic marker*.

Significantly, the cancer cell proliferation and tumour reducing effect can be measured with both markers and by the direct measurement of reduced cancer cell proliferation in a drug dose dependent manner. This information means that a more comprehensive use of the marker diagnostics will be made in the therapeutic clinical assessment of VAL201. The assays for these biomarkers are proven for use in the clinical trial and they will be used as part of the assessment of the trial outcome.

A second encouraging study delivered preliminary positive results in non-hormonal breast cancer models, using cell viability and cell growth markers. In this study, VAL201 was shown to decrease the proliferation or spread of cancer cells, as measured by the markers.

Dr Satu Vainikka, CEO of ValiRx, commented: 

"ValiRx's ability to use biomarkers to measure the reducing effect VAL201 has on prostate cancer models, is very encouraging and we are excited to see that by using different biomarkers, we have been able to measure VAL201's impact on reducing both the proliferation and spread of the prostate cancer and of the actual tumour growth".

"As I have said before, biomarkers are crucial for detecting cancer at an early stage and they are also key in optimising therapeutic strategy and monitoring therapeutic success. It is a market that is rapidly growing in size with the potential benefit for patients being significant".

"I look forward to our ValiFinn biomarker unit continuing to assist our studies and trials into VAL201 and VAL101 and to our ability to leverage off this specialist expertise, to advance in-house the development of companion biomarker diagnostics to complement the Company's therapeutics".

* PSA

 PSA is present in small quantities in the serum of men with healthy prostates, but is often elevated in the presence of prostate cancer or other prostate disorders. PSA is not a unique indicator of prostate cancer, but it can also detect prostatitis or benign prostatic hyperplasia. Although only 30 percent of patients with high PSA have prostate cancer diagnosed after biopsy, it does remain the primary indicator of choice in Prostate cancer evaluation.

- ENDS -

For more information, please contact:

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 personalized 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.

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