ValiSeek Clinical Development Update

RNS Number : 1935O

ValiRx PLC

03 November 2016

 

VALIRX PLC

("ValiRx" or "the Company")

VALISEEK CLINICAL DEVELOPMENT UPDATE

"Progress continues in VAL401-001 trial with patients continuing treatment"

London, UK., 3 November 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 VAL401 into clinical trials for the treatment of lung cancer and other oncology indications.

Following our announcement on 11 August 2016 that all regulatory approvals had been received for the VAL401-001 clinical trial in Tbilisi, Georgia, ValiSeek is pleased to report back from the clinical team meeting held in Tbilisi this week.

Dr Suzy Dilly, Dr George Morris and Dr Victoria D'Aquino attended the meeting on behalf of ValiSeek, with the Tbilisi-based team at Clinical Accelerator joining the Investigators and clinical support staff at the Medulla Immunotherapy and Chemotherapy Clinic (the "Clinic"). 

The Clinic reported that as the first patient has proceeded sufficiently through the dosing phase of the protocol, the second patient is now approved to also commence dosing.  Additionally, the screening procedure for further enrolment remains underway.  As dictated by the agreed protocol, these patients have undergone biochemical and safety testing prior to dosing and the dosed patient has continued to be monitored following the first dose of VAL401.  This close monitoring continues until the patients are adjusted to the effects of the medication, after which the patients maintain dosing for 6 months, with routine monitoring and testing at regular intervals. 

The Company is delighted that the Clinic reported in the meeting that the patient is tolerating the treatment well, has experienced no drug-related adverse events and remains enthusiastic about continuing on the trial. 

As part of the initial biochemical testing, pharmacokinetic samples have been collected and are being analysed for patient exposure levels to Risperidone displayed by our formulation.  Full analysis of this data will be performed after collection from all 20 patients to be enrolled into the trial over the coming months.

Our meeting in Tbilisi provided an opportunity for positive interaction between the teams, which is crucial at this stage, allowing early assessment of the potential rate of recruitment, success of the logistical set-up and feedback on the patients' early experiences with the treatment.

These results will be presented in greater detail by Dr Dilly to partnering participants at the Bio-Europe conference in Cologne from the 6^th - 9^th November 2016.

Dr Suzanne Dilly, CEO of ValiSeek Limited, commented: "Our trip to Tbilisi has been very useful in increasing our understanding of the position of VAL401 in the treatment environment.  To see the enthusiasm of the Clinical team and in particular to learn about the equal enthusiasm of the patients, provided a welcome reassurance that both the trial and the treatment have been designed appropriately and with the correct ethical influence in mind and that our goal to improve patients' quality of life is achievable."

Dr George Morris, COO of ValiRx Plc, added: "I am delighted to see VAL401 progressing into the clinic so satisfactorily and it was very useful to join Suzy on the trip to Tbilisi.  This excellent news continues our joint momentum towards new clinical developmental milestones and I look forward to VAL401's continuing and exciting progress."

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

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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

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 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 three 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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