ValiRx Regulatory News (VAL)

15 January 2015

ValiRx Plc

("ValiRx" or "the Company")

Clinical Trial and Development Update

on VAL201 and VAL401 for oncology indications

"Preliminary results for VAL201 anticipated in Q1 2015"

"Advice sought from MHRA prior to VAL401 progressing into formal clinical trial"

Following the successful dosing of the first clinical study cohort with VAL201, subsequent cohorts of patients are now in the recruitment process and preliminary information from the first study is anticipated in Quarter 1, 2015. The clinical unit at University College London Hospital "(UCLH") is conducting the study.

The main objectives of the study are to confirm safety and tolerability. Then progressing through the dose escalation and expansion stages, the study is designed to investigate further details of these aspects as well as efficacy. Particular emphasis will be placed on evaluating the pharmacokinetics and early assessment of anti-tumour activity in response to VAL201, by using a variety of measurements including ValiRx's biomarkers.

VAL201 selectively stalls tumour growth by specifically preventing 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. 

VAL401

VAL401 is the reformulation of a generic drug that has over 20 years of clinical use for treatment of a chronic CNS disease*.

The toxicology studies on VAL401 are now complete with no adverse events reported. Further analysis of the data has completed the pre-clinical regulatory packages, which include pharmacokinetics, drug distribution and exposure.

Advice is now being sought from the licensing authority, the Medicines and Healthcare Products Regulatory Agency ("MHRA"), using both the newly reformulated and original safety data from the previous clinical usage of the drug, with a view to progressing VAL401 into a pivotal formal clinical trial regarding its efficacy in the treatment of cancer. A meeting has been arranged with the MHRA.

A clinical biomarker for the identification of patients appropriate for treatment with VAL401 has been proposed and work has been commissioned through ValiRx's subsidiary, ValiFinn Oy, to establish and validate this methodology.

Dr Satu Vainikka, CEO of ValiRx, commented: "We have seen a significant period of progress for ValiRx over the past twelve months, with our lead compound VAL201 having advanced into patient clinical trials and with our portfolio of other drug candidates also seeing encouraging progress."

"With recent developments, ValiRx is now well placed to execute its future clinical plans and build itself a strong position addressing the challenge and treatment of cancers."

*  ValiSeek Limited ("ValiSeek"), the joint venture subsidiary with Tangent Reprofiling Limited, was formed last year to progress the drug VAL401 through its remaining preclinical development and towards clinical trials for the treatment of lung cancer and other oncology indications.

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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.