ValiRx Regulatory News (VAL)

ValiRx Plc (AIM: VAL)

("ValiRx" or "the Company")

Clinical Phase Development Update re VAL201 and VAL401

London, UK., 19 November 2015 - ValiRx Plc (AIM: VAL), a life science company with a focus on cancer therapeutics and diagnostics for personalised medicine, today announces that its lead compound, VAL201, is completing the dose escalation part of its Phase l/ll Clinical Trial.

VAL201 demonstrates safety and tolerability and no significant adverse effects have been recorded, confirming the previously announced First-In-Human results. Other measurements taken so far are comparable to the positive results seen pre-clinically.

For the expansion phase, further Clinical Trial Centres, in addition to UCLH, are being opened in order to extend the availability of test patients. This phase will continue during 2016 as described in the approved protocol. During the latter part of the trial, the primary and secondary outcomes will be further refined and results relating to the applicability and efficacy of the treatment will be expanded.

Public details of the trial can be found on the website www.Clinicaltrials.gov. 

VAL401

Following on from the earlier announcement of the establishment of a Clinical Trial Contract with Clinical Accelerator, the protocols and associated files have been drafted for submission to the appropriate regulatory authorities and ethics committees.

The trial is to be entitled: "A Phase II study to assess the efficacy, safety and tolerability of VAL401 in the treatment of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) after failure of at least one prior chemotherapeutic regimen".

The preparatory clinical process is proceeding according to timetable and it is anticipated that the trial will begin recruitment during the earlier part of 2016.

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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 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 Alternative Investment Market ("AIM") 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.