ValiSeek Clinical Development Update

RNS Number : 1302E

ValiRx PLC

14 July 2016

 

ValiRx Plc

("ValiRx" or "the Company" or "the Group")

ValiSeek Clinical Development Update

"Ethics Committee Approval Received"

London, UK., 14 July 2016: ValiRx Plc (AIM: VAL), a life science company, which focuses on clinical stage cancer therapeutic development, taking proprietary & novel technology for precision medicines towards commercialisation and partnering, is pleased to provide an update on the clinical development of its novel cancer treatment drug, VAL401.

ValiSeek, the joint venture between ValiRx and Tangent Reprofiling Limited, was formed to progress the compound VAL401, towards Clinical Efficacy trials for the treatment of lung cancer and other oncology indications.

Ethics Committee Positive Opinion & Approval

ValiSeek confirms that it has received a positive opinion recommending approval of the trial protocol from the Ethics Committee covering its clinical site in Tbilisi, which is a significant step in the regulatory process prior to patient recruitment and dosing.  Approval from the Ethics Committee is a precondition and integral element in the Georgian regulatory approval process.  It is a year since ValiRx first announced the commencement of the clinical process for the testing of VAL401 in the treatment of patients with lung cancer.

This opinion will now be combined with ValiSeek's extensive documentation on the planned trial and on the drug capsule manufacture, for its final submission to the Competent Authority in Georgia for the regulation of clinical trials.

If the final submission to the Georgian Competent Authority is positive, ValiSeek would then have necessary consents to launch the clinical trial site and to import the test drug, VAL401; thereby allowing clinicians to start identifying patients for participation in the trial - "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".

Manufacture of first clinically compliant batch of VAL401 capsules now complete

Further to the 19 May 2016 announcement regarding the initiation of Clinical Manufacturing of the VAL401 capsules for this trial, ValiSeek is pleased to also confirm that the first batch of the VAL401 capsules for use in the trial has completed primary manufacture.  The capsules are now undergoing final quality control procedures before shipment to Tbilisi for patient dosing.

ValiSeek has taken another important step towards the dosing of VAL401 in patients and ValiRx looks forward to providing further updates as the Clinical Trial advances and at the broadening of its clinical pipeline.

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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]
Mark Treharne, Corporate Development Manager	Tel: [phone] [e-mail]
Cairn Financial Advisers LLP (Nominated Adviser)	Tel: [phone]
Liam Murray / Jo Turner
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 is a biotechnology oncology focussed 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 Word 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 Alternative Investment Market ("AIM") of the London Stock Exchange in October 2006 and trades under the ticker symbol: VAL.

 

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