VAL201 Clinical Trial Update

RNS Number : 5740T

ValiRx PLC

21 July 2015

 

ValiRx Plc

("ValiRx" or "the Company")

VAL201 CLINICAL TRIAL UPDATE

London (July 21^st 2015) - Further to its announcement on 25 June 2015, Valirx Plc (AIM: VAL) provides a further update on its lead compound, VAL201, in its Phase l/ll dose escalation clinical trial, which is approved to include patients with locally advanced or metastatic prostate cancer and other advanced solid tumours.

Over the past month, the approved incremental dose escalation has continued to demonstrate safety and tolerability, with no significant adverse effects recorded.  In addition, the compound continues to show similar properties and results in terms of delaying disease progression in patients with locally advanced or metastatic prostate cancer to those witnessed in pre-clinical studies.

In light of the additional safety and tolerability data that has been obtained, the next dose escalation has been approved, which may prove sufficient to show anti-tumour activity. This would continue a trend that, thus far, has been seen throughout the clinical trial.

The trial is on track and is proceeding according to timetable. As the trial proceeds, further updates and information will be provided.

Dr Satu Vainikka, CEO of ValiRx, commented: "Again it is good to be reporting that the VAL201 trial continues to proceed well and as planned.  I am pleased to say that, at this stage, a good safety profile has been seen and potential efficacy continues to be noticed.

"We are now nearing dose levels that we originally projected would be therapeutically significant and as such, I enthusiastically look forward to VAL201's continued clinical trial progress and to updating investors accordingly."

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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 (Corporate Finance) 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 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.

 

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