VALIRX PLC

Legal Proceedings Report • Mar 20, 2018

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RNS Number : 2012I

ValiRx PLC

20 March 2018

VALIRX PLC

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

US PATENT GRANT

FOR THERAPEUTIC COMPOUND, VAL201

London, UK., 20 March 2018: ValiRx Plc (AIM: VAL), the clinical stage biotechnology company, is pleased to announce that the United States of America patent and trademark office has granted the US Patent Application No. 14/575065 ("Anti-Androgen Peptides and Uses Thereof in Cancer Therapy") covering ValiRx's lead therapeutic compound, VAL201, which is in clinical trials.  This follows the Company's earlier announcement on 11 January 2018, regarding its receipt of a US Patent Notice of Allowance.

The patent application covers the molecule and use of compounds in pharmaceutically acceptable products. The patent coverage also includes a wide variety of derivatives, modifications and analogues of the compounds and their mode of action. Furthermore, the protection sought includes therapeutic formulations with associated delivery systems.

The grant of this US patent for VAL201 represents one of the cornerstones of the Company's commercial strategy, since ValiRx has already secured patent protection in several other territories, including Europe.  This positioning, in having patent protection in major markets, is in line with the pharmaceutical industry's increasing search for novel proprietary therapies in the oncology arena.

The table below provides details of patents in the VAL201 portfolio that have been either fully granted or allowed. 

Country	Patent number	Date Filed	Granted/Allowed
United States	US 14/575065	14 March 2008	Granted
Europe	EP 08717866.1	14 March 2008	Allowed
Japan	JP 2009-553162	14 March 2008	Granted
Australia	AU 2008228274	14 March 2008	Granted
United Kingdom	GB 1118831.5	01 November 2011	Granted
There are patent applications currently pending in many other territories and covering various aspects of the programme.

As announced on 18 December 2017, the compound is currently in a Phase I/II study primarily assessing safety and tolerability of VAL201 and its effect in the treatment of prostate cancer and other solid tumours.  No dose limiting toxicity has been observed, nor have there been any therapeutically-related side effects (Serious Adverse Events).  

So far VAL201 has met and exceeds the predicted safety and tolerability criteria set for the trial.  Subjects have shown preliminary therapeutic efficacy and significant changes in their PSA levels related to treatment with VAL201.  These are in line with pre-clinical studies, which have shown efficacy in prostate, breast and ovarian cancer models as well as addressing endometriosis or hormone induced abnormal cell growth in women.

Dr Satu Vainikka, CEO of ValiRx, commented: "I am delighted that VAL201 is now in receipt of a US patent grant and it comes at an opportune time for the Company and shortly after we received approval from the UK Medicines and Healthcare Products Regulatory Agency and Research Ethics Committee for the Company to expand its VAL201 trial to more speedily reach VAL201's full therapeutic potential and potential anti-cancer impact". 

"This US grant further strengthens the VAL201 patent portfolio and provides ValiRx with patent protection in all its largest commercial markets globally. ValiRx continues to look forward confidently to further securing value across its therapeutic portfolio."

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

*** ENDS ***

For more information, please contact:

ValiRx plc	Tel: +44 (0) 20 3008 4416 www.valirx.com
Dr Satu Vainikka, Chief Executive	Tel: +44 (0) 20 3008 4416
Tarquin Edwards, Head of Communications.	Tel: +44 (0) 7879 458 364 tarquin.edwards@valirx.com
Cairn Financial Advisers LLP (Nominated Adviser) Liam Murray/Jo Turner/Richard Nash	Tel: +44 (0) 20 7213 0880
Novum Securities Limited (Broker) Colin Rowbury	Tel: +44 (0) 20 7399 9400

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 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 AIM Market of the London Stock Exchange in October 2006 and trades under the ticker symbol: VAL.

This information is provided by RNS

The company news service from the London Stock Exchange

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