Quarterly Update

RNS Number : 3732A

ValiRx PLC

07 June 2016

 

ValiRx Plc

("ValiRx" or "the Company")

QUARTERLY UPDATE ON CLINICAL DEVELOPMENTS

"Good progress on both Commercial and Scientific Fronts"

London, UK, 7^th June 2016: ValiRx Plc (AIM: VAL), a life science company with a focus on cancer diagnostics and therapeutics for personalised medicine, provides a quarterly Q2 update on clinical progress.

 VAL201

ValiRx's lead compound, VAL201, continues to perform well in its Phase l/ll Clinical Trial in patients with hormone resistant prostate cancer and the Company was pleased to confirm in February 2016 that VAL201 is well tolerated and has shown a high degree of safety. To date, no drug related significant adverse events have been reported. Dose escalation has reached therapeutic levels and the studies have shown early indications of efficacy. The primary and secondary endpoints of the clinical trial have been further refined and confirmed and they continue to show no drug related adverse events.

Additional Clinical Trial Centers are being integrated into the study to assist with the dose expansion stage of the trial and this enlargement will expedite the production of data in order to complete the trial within the projected and regulatory-agreed time frame.  ValiRx has also begun the process of designing the follow-up full efficacy study of VAL201 in prostate cancer. These will include a review of the most appropriate jurisdictions in which to undertake the work. This process and the development of the actual protocol, with costings and partnerships in place, is expected to be completed and in place by the time that the current Phase I/II trial reports.

In light of the excellent results shown by the compound and the promising pre-clinical evidence of the compound's effect on endometriosis, the Company is continuing the design of the protocol for this indication and to test VAL201 for its in-human potential in the treatment of this debilitating female condition.  The protocol and associated partnerships - both commercial and technical - are expected to be in place before the final reporting of the current 'safety and tolerability-focused' clinical trial.

Furthermore, the opportunity for developing and exploiting the compound for a further indication in the treatment of endometriosis or hormone induced abnormal cell growth in women, via partnering and collaboration, is similarly fast approaching and the necessary preparatory steps and conversations are underway.

VAL401

Within the quarters Q1 and Q2 this year, ValiSeek Limited ("ValiSeek"), the joint venture between ValiRx and Tangent Reprofiling Limited, has made progress on both commercial and scientific fronts.

Regulatory documentation has been prepared for a clinical Phase II efficacy study. The trial will take place in Georgia, with sites, investigators and facilities now confirmed.  Initial site visits have been carried out recently by Dr Suzy Dilly and Dr George Morris, in alliance with the Georgian team at Clinical Accelerator, the UK-based clinical trial management organisation. Key criteria for the selection of the principle investigators have included their enthusiasm for our treatment paradigm, as a result of their understanding of our pre-clinical results to date.

Scientific progress has included the manufacture of clinical grade VAL401 capsules and this production is a crucial step in VAL401's progression towards the dosing phase of its clinical trial: (VAL401-001: "A Phase II study to assess the efficacy, safety and tolerability of VAL401 in the treatment of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) after failure of at least one prior chemotherapeutic regimen"). 

A second US patent - in this case covering the use of the VAL401 formulation as a treatment for adenocarcinoma - has been allowed by the US patent office. With this patent providing IP protection in the largest oncology market in the world, ValiSeek consider this patent to be a substantial asset, both validating and underpinning ValiSeek's potential future valuation.  ValiSeek anticipates that further international patent protection will be confirmed in the coming months.

The next steps in the VAL401 regulatory pathway will include receipt of local ethics committee approval prior to ValiSeek receiving the final regulatory go-ahead to recruit patients.

*** ENDS ***

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]
Mark Treharne, Corporate Development Manager	Tel: [phone] [e-mail]
Cairn Financial Advisers LLP (Nominated Adviser)	Tel: [phone]
Liam Murray
Northland Capital Partners Limited (Joint Broker)	Tel: [phone]
Patrick Claridge / David Hignell (Corporate Finance) John Howes / Abigail Wayne (Broking)
Beaufort Securities Limited (Joint Broker)	Tel: [phone]
Jon Belliss

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 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 Reprofiling Ltd to develop VAL401 in lung cancer and potentially other indications.

 

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