UPDATE on VAL201 Clinical Trial

RNS Number : 1585R

ValiRx PLC

25 June 2015

 

ValiRx Plc

("ValiRx" or "the Company")

UPDATE on VAL201 Clinical Trial

London, UK, 25 June 2015 - ValiRx Plc (AIM: VAL), a life science company with a focus on cancer therapeutics and diagnostics for personalised medicine, provides an update on its lead compound, VAL201, in its Phase l/ll dose escalation clinical trial. The trial has been approved to include patients with locally advanced or metastatic prostate cancer and other advanced solid tumours at University College London Hospital.

The trial to date has successfully demonstrated safety and tolerability and there have been no significant adverse effects. There are preliminary indications that the compound VAL201 is demonstrating the effects that have been seen in the preclinical studies.

The trial is now advancing through the planned dose escalation, where further safety and tolerability testing is being undertaken and efficacy will be further investigated. Where increased dosing has been undertaken, no significant adverse effects have occurred.

Further subjects have been identified and recruited according to the criteria laid out in the trial protocol.  The trial is on track and proceeding according to the timetable and plan. Future updates will be provided as the trial progresses.

Dr Satu Vainikka, CEO of ValiRx, commented: "The trial continues to proceed well and I am pleased to be able to say that, at this preliminary stage, potential efficacy has been detected at the lowest doses. I look forward to making further updates in due course."

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For more information, please contact:

ValiRx plc	Tel: [phone]
Dr Satu Vainikka	www.valirx.com
Cairn Financial Advisers LLP (Nominated Adviser)	Tel: [phone]
Liam Murray / Avi Robinson
Northland Capital Partners Limited (Broker)	Tel: [phone]
Patrick Claridge / David Hignell John Howes / Abigail Wayne (Broking)
Peckwater PR	Tel: [phone]
Tarquin Edwards	[e-mail]

Notes for Editors

About the Phase I/11 Clinical Trial

The main objectives of the Phase I/II study are to confirm safety and tolerability.  Progressing through the dose escalation and expansion stages, the study is then designed to investigate further details of these aspects as well as efficacy. Particular emphasis will be placed on evaluating the pharmacokinetics, pharmacodynamics and early assessment of anti-tumour activity in response to VAL201, using a variety of measurements including ValiRx's biomarkers, with biomarkers being key indicators in personal medicine.  Biomarkers are critical, firstly in identifying which individuals and which cancers can be helped, before then being used in the monitoring of those patients for therapeutic effectiveness.   Finally, they significantly assist in the accurate prediction for and long-term prognosis of patients.

VAL201 selectively prevents tumour growth by specifically inhibiting the proliferation of tumour cells.  As a result, tumour growth is suppressed and metastasis is significantly reduced. The approach is a targeted therapeutic with pre-clinical results that indicate that due to the specific nature of this treatment, this therapy is likely to be less toxic than many other therapeutic options.

The VAL201 target is also associated with other cancers and there is significant potential for VAL201 to be used as a treatment for other hormone-induced cancers, such as breast and ovarian and also endometriosis.

The global market for prostate cancer products looks set to expand to US$7-9 billion by 2020, due to the growing prostate cancer population, which is predicted to expand by 25% from 2010 to 2020 (GlobalData 2012) with many of the other potential indications also expanding at rapid rates.

Details of the trial can be found on clinicaltrials.gov, where they are posted as a legal requirement and part of the extensive work required to reach this stage of human testing in the clinical development of VAL201.

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.

 

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