Update on VAL201 Clinical Trial

RNS Number : 8910J

ValiRx PLC

09 December 2018

 

VALIRX PLC

("ValiRx" or the "Company")

UPDATE ON VAL201 CLINICAL TRIAL

"Positive Effect on Cancer Patients"

"Evidence revealed of decrease in prostate cancer biomarker PSA, related to dosing with VAL201"

London, UK., 10 December 2018: ValiRx Plc (AIM: VAL), the clinical stage biotechnology company, is proud to announce that independent analysis of VAL201 data shows a statistically significant dose dependant response in the reduction of PSA correlated to time on the Phase l/ll clinical trial, involving patients with hormone-sensitive and hormone-resistant prostate cancer.

This represents an initial formal statistical analysis of the VAL201 clinical data conducted by Dr Wilson Caparrós-Wanderley, an independent statistical consultant.  This was undertaken using a non-parametric approach - both the well-established 'Friedman Test' (developed by M. Friedman in 1937) and the most up-to-date statistical method, 'Repeated Measures Multiple Correlation Analysis' (refined by Bakdash and Marusich in 2017).

This analysis reveals that volunteers treated with VAL201 display a statistically significant correlation for reductions over time in the amount of Testosterone and Prostate Specific Antigen ("PSA"), both of which are commonly-used markers for disease progression in prostate cancer.

The data further confirms that VAL201 has no statistically significant adverse trends across liver or kidney function.  Furthermore, with no impact on cardiac rhythm in the patients either, this data further reinforces the continuation of the good safety and tolerability data emerging from the trial.

In addition to the independent analysis, the pharmacokinetics information collected from the clinical evaluation of ValiRx's more recent patients, shows that ValiRx is addressing the protocol's primary and secondary endpoints - as well as all the exploratory tertiary end points.

Further information about the endpoints is to be found posted on the NIH website, www.ClinicalTrials.gov, under: 'Dose Finding Safety Study of VAL201 in Cancer Patients (VAL201-001)'.

Dr Satu Vainikka, CEO of ValiRx, commented: "I am delighted to receive this analysis from an external expert, showing that VAL201 is having a positive and desired effect on prostate cancer patients' disease markers.  Effectively, the more a patient takes VAL201, the more a patient's PSA will decrease".

"This is fantastic news and it heralds our entry into the pivotal stage of VAL201's clinical trial programme.  I thank the team for their hard work in delivering these very encouraging and positive outcomes".

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

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For more information, please contact:

ValiRx plc	Tel: [phone] www.valirx.com
Dr Satu Vainikka, Chief Executive	Tel: [phone]
Tarquin Edwards, Head of Communications.	Tel: [phone] [e-mail]
Cairn Financial Advisers LLP (Nominated Adviser) Liam Murray/Jo Turner/Richard Nash	Tel: [phone]
Novum Securities Limited (Broker) Colin Rowbury	Tel: [phone]

Notes for Editors

About ValiRx

ValiRx is a biotechnology oncology focused company specialising in developing novel treatments for cancer and associated biomarkers.  It aims to make a significant contribution in "precision" medicine and science, namely to engineer a breakthrough into human health and well-being, through the early detection of cancer and its therapeutic intervention.

The Company's business model focuses on out-licensing therapeutic candidates early in the development process.  By aiming for early-stage value creation, the company reduces risk considerably while increasing the potential for realising value.  The group is already in licensing discussions with major players in the oncology field.

ValiRx's two classes of drugs in development, which each have the potential for meeting hitherto unmet medical needs by existing methods, have worldwide patent filings and agreed commercial rights.   They originate or derive from World class institutions, such as Cancer Research UK and Imperial College.

Until recently, cancer treatments relied on non-specific agents, such as chemotherapy.  With the development of target-based agents, primed to attack cancer cells only, less toxic and more effective treatments are now possible.  New drugs in this group-such as those in ValiRx's pipeline-promise to greatly improve outcomes for cancer patients.

The Company listed on the AIM Market of the London Stock Exchange in October 2006 and trades under the ticker symbol: VAL

 

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