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ValiRxAnnouncement

25/07/2015 09:41

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RNS Number : 5740T
ValiRx PLC
21 July 2015 
 
ValiRx Plc 
 
("ValiRx" or "the Company") 
 
VAL201 CLINICAL TRIAL UPDATE 
 
London (July 21st 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." 
 
*** ENDS *** 
 
For more information, please contact: 
 
 ValiRx plc                                                                                Tel: +44 (0) 20 3008 4416          
 Dr Satu Vainikka                                                                          www.valirx.com                     
                                                                                                                              
 Cairn Financial Advisers LLP (Nominated Adviser)                                          Tel: +44 (0) 20 7148 7900          
 Liam Murray / Avi Robinson                                                                                                   
                                                                                                                              
 Northland Capital Partners Limited (Broker)                                               Tel: +44 (0) 20 7382 1100          
 Patrick Claridge / David Hignell (Corporate Finance)John Howes / Abigail Wayne (Broking)                                     
 Peckwater PR                                                                              Tel: +44 (0) 7879 458 364          
 Tarquin Edwards                                                                           tarquin.edwards@peckwaterpr.co.uk  
 
 
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. 
 
This information is provided by RNS
The company news service from the London Stock Exchange