24 February 2015
ValiRx Plc
("ValiRx" or "the Company")
ValiRx reports on successful first results from a
Phase I/II Clinical Trial of VAL201 in patients with cancer
ValiRx Plc (AIM: VAL), the life science company with a focus on cancer diagnostics and therapeutics for personalised medicine, is pleased to announce that its lead compound, VAL201 was safe and well tolerated at the doses tested.
With this result, the trial will advance to the next elevation of dose, where further safety and tolerability testing will be undertaken and early stage efficacy will continue to be investigated as the trial progresses. The trial is directed towards providing information on the maximum applicable dose level possible.
The clinical trial is a dose escalation study to assess the safety and tolerability of VAL201 in patients with locally advanced or metastatic prostate cancer and other advanced solid tumours.
In addition, ValiRx is pleased that its newly acquired TRAC biomarker diagnostic and development technology is now fully established in ValiFinn's clinical labs.
Dr Satu Vainikka, CEO of ValiRx, commented:"This first result from the clinical trial of the ValiRx compound VAL201 demonstrates a good safety profile and I am pleased to see the study successfully progressing well."
Webcast Presentation
A webcast interview by Dr George Morris, COO of ValiRx on the successful first results from the VAL201 Clinical Trial is available at 09:00 today by clicking on the following link: http://brrmedia.co.uk/event/135292?popup=true
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 $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.
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For more information, please contact:
ValiRx plc |
Tel: +44 (0) 20 3008 4416 |
Dr Satu Vainikka |
www.valirx.com |
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Cairn Financial Advisers LLP (Nominated Adviser) |
Tel: +44 (0) 20 7148 7900 |
Liam Murray / Avi Robinson |
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Daniel Stewart & Company Plc (Broker) |
Tel: +44 (0) 20 7776 6550 |
Martin Lampshire |
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Peckwater PR |
Tel: +44 (0) 7879 458 364 |
Tarquin Edwards |
[email protected] |
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 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.
