REG - ValiRx PLC - ValiSeek Development Update <Origin Href="QuoteRef">VALX.L</Origin>

ValiRxAnnouncement

15/07/2015 17:32

RNS Number : 1209N
ValiRx PLC
14 May 2015
14 May 2015
ValiRx Plc
("ValiRx" or "the Company")
ValiSeek Development Update - completion of pre-clinical studies
ValiRx Plc (AIM: VAL), the life science company with a focus on cancer diagnostics and therapeutics for personalised medicine, is pleased to provide a development update on the progress of pre-clinical studies at ValiSeek Limited ("ValiSeek") on the first anniversary of the joint venture between ValiRx and Tangent Reprofiling Limited.
ValiSeek was formed to progress the novel cancer treatment drug, VAL401, towards Clinical Efficacy trials for the treatment of lung cancer and other oncology indications.
Further to the Company's update on 15 January 2015, ValiSeek reports on the completion of its pre-clinical toxicology and pharmacokinetic studies. 
Preclinical efficacy of VAL401 in the treatment of adenocarcinoma tumours has been confirmed in pancreatic and non-small cell lung cancer models in addition to the prostate cancer models previously run by Tangent. The newly reported pancreatic data shows VAL401 to demonstrate comparable anti-tumour activity to clinical drug Gemcitabine in an adenocarcinoma model. As a further area of high unmet medical need, this additional data in pancreatic cancer enhances the overall commercial value of the VAL401 project.
Preclinical toxicology and pharmacokinetic studies have been completed to the required regulatory standards confirming safety, tolerability, distribution and metabolism of VAL401 as comparable to the conventionally formulated clinical active drug. This ensures the prior clinical data can be included as supporting information in regulatory submission packages without further safety studies.
Prototype manufacturing of encapsulated VAL401 in the oral clinical format has been completed and formal stability studies are underway. 
Clinical-based regulatory planning and the process has commenced with a first Science Advisory Meeting taking place between ValiSeek and the Medicines and Healthcare Products Regulatory Agency ("MHRA") in late February 2015. This meeting introduced the MHRA panel of scientific assessors to the VAL401 project, thereby initiating the regulatory process and ensuring a smooth set-up of the appropriate late stage clinical trial.
2015 BIO International Convention
Along with parent company ValiRx Plc, ValiSeek has been invited to join the UK trade visit to the 2015 BIO International Convention in Philadelphia, Pennsylvania (14-18 June 2015). As detailed in ValiRx's announcement of 30 April 2015, "The Market Visit" has been organised by the Mayor of London's Export Programme, in partnership with UK Trade & Investment (UKTI) to offer London SMEs an opportunity to attend this major industry international event and a chance to partner with the world's leading pharmaceutical and biotechnology companies.
Dr Suzanne Dilly, CEO of ValiSeek Limited, commented:"With clinical-based regulatory planning and documentation now commencing for VAL401, I look forward to the formal clinical trial application progressing according to schedule and building further momentum."
Dr Satu Vainikka, CEO of ValiRx plc, added: "The ValiSeek drug development is moving forward well and we are very pleased to see VAL401's move into the clinic."
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For more information, please contact:
ValiRx plc
Tel: +44 (0) 20 3008 4416
Dr Satu Vainikka
www.valirx.com


Cairn Financial Advisers LLP (Nominated Adviser)
Tel: +44 (0) 20 7148 7900
Liam Murray / Avi Robinson



Daniel Stewart & Company Plc (Broker)
Tel: +44 (0) 20 7776 6550
Martin Lampshire

Peckwater PR
Tel: +44 (0) 7879 458 364
Tarquin Edwards
tarquin.edwards@peckwaterpr.co.uk
Notes for Editors 
About ValiSeek
ValiSeek Limited ("ValiSeek") is a joint venture ("JV") company between ValiRx Plc and Tangent Reprofiling Limited, part of the SEEK Group. ValiSeek was formed to progress the drug VAL401 through its remaining preclinical development and towards Phase II trials for the treatment of lung cancer and other oncology indications
About SEEK
Founded in 2004, SEEK (previously known as PepTcell) is privately owned and funded, with headquarters in London, UK. SEEK brings safe and low costs medicines to the patients as quickly as possible. It does this by modifying existing medicines to improve their efficacy within current label, dose and regime, by changing the indication but keeping the dose and dosing regime the same or by creating a new medicine when the previous options are unavailable.
Additional information about SEEK is available on the Company's website located at www.seekacure.com
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 todevelop a novel and groundbreaking class of therapeutics across a number offields in oncology and has taken its lead compound, Val201, into Phase I/IIclinicaltrials. The Company listed onthe Alternative Investment Market ("AIM") of the London StockExchange in October 2006.
The Company has a pipeline ofother therapeutic drugs, which are currently progressing towards clinicaltrials. The product focus is in the targeted analysis and treatment of cancer,but thetechnologies can be applied to other fields as well, such as neurologyand inflammatory diseases.
It actively manages projectswithin its portfolio as a trading company. The ValiRx business model spreads the risks of life science technologydevelopment by minimising financial exposure andrunning a set of projects todefined commercial endpoints. This maximises returns to shareholders by adding value at the earlier stages where value increases per investment unit are thegreatest.
The Company operates through thefollowing divisional companies:
1. ValiPharma is the therapeuticsdivision, with two embedded technologies primarily directed at the treatment ofcancers.
2. ValiFinn is the biomarkers anddiagnostic development division. ValiRxacquired through its ValiFinn subsidiary, the complimentary TRAC technologylater in the year to strengthen the portfolio.
3. ValiSeek is a joint venturebetween ValiRx and Tangent Reprofiling Ltd to develop Val401 in lung cancer and potentiallyother indications.

This information is provided by RNS
The company news service from the London Stock Exchange
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