Quarterly Update on Clinical Developments

RNS Number : 3594Q

ValiRx PLC

29 November 2016

 

ValiRx Plc

("ValiRx" or "the Company")

QUARTERLY UPDATE ON CLINICAL DEVELOPMENTS

London, UK., 29 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, provides a quarterly Q4 update on clinical progress.

VAL201

Over the last quarter, ValiRx's lead compound, VAL201, continues to perform well in its "Phase I/II dose escalation study to assess safety and tolerability of VAL201 in the treatment of prostate cancer and other solid tumours". This is a dose escalation and pharmacokinetic study to assess the safety and tolerability of VAL201 in patients with advanced stage prostate cancer (APC).

The study's aim is to assess primarily VAL201's safety and secondary tolerability and in addition, to examine as a subsidiary event the activity of VAL201 in patients with advanced prostate cancer.  The study is a titration, open label, dose-escalation trial designed to identify a maximum tolerated or administered dose (MTD/MAD).

In order to be considered for inclusion in the trial, patients need to have incurable, locally advanced or metastatic prostate cancer and to have relapsed following radical therapy.  They are to be in a 'watchful waiting' period, where a policy of intermittent hormone therapy has been decided.  Various other factors are required relating to disease progression and medication, such as reputedly increasing PSA levels during the screening period.

To date VAL201 has been subcutaneously delivered on Days 1, 8 and 15 of a 21-day cycle repeated up to six times in each subject. The first cohort being given 0.5 mg/kg of compound and this has been increased to 5.0mg/kg over 5 cohorts, dose levels (DL).

No dose limiting toxicity (DLT) has been observed to date, nor have any therapeutically related serious adverse events (SAE). Mild fatigue and temporary injection site rashes are the only adverse events seen in treated subjects. The conclusions that can be drawn at the moment are that VAL201 has met and currently exceeds the predicted safety and tolerability criteria set for the trial and that so far the vast majority of patients who have completed the study showed stable disease on imaging and following treatment, with more subjects still being followed. Furthermore, the majority of subjects on a significant dose have shown significant changes in PSA levels related to their treatment with VAL201.  Analysis of samples is ongoing. Our initial observations are that the clinical results correlate with the pre-clinical model systems and projections.

Following the success of the trial so far, it is to be expanded in patient numbers with the inclusion of several new study centers and this extension will have a strong focus on the effects of VAL201 on advance prostate cancer with a wider scope for patient inclusion. 

VAL401

Q4 2016 has been a ground breaking quarter in terms of VAL401's clinical development. As announced on 3 November 2016 following the clinical team meeting held in November in Tbilisi, the Company was delighted to announce that the first dosing of patients had commenced in VAL401'S Phase II trial for the treatment of lung cancer and other oncology indications.

ValiSeek, the joint venture between ValiRx and Tangent Reprofiling Limited, reported that as a first patient had proceeded sufficiently through the dosing phase of the protocol, a second patient was approved to also commence dosing and that the screening procedure for further enrolment was underway. 

We are pleased to report that these two patients continue on the trial, with initial pharmacokinetic data collected for both.  Although full pharmacokinetic interpretation will be carried out only when all 20 patients have acquired data entries, initial analysis shows levels of active drug and known metabolite to be present in blood samples as expected.

Full details and the up-to-date status of the trial can be found registered on: Clinicaltrials.gov

ValiSeek attended the Bio-Europe partnering event in Cologne in early November, with Dr Dilly partaking in 19 pre-arranged meetings with attending companies, including biotech, pharma, PR and service companies, some of which were follow-up meetings from prior events, and others new introductions.  The presentations within these meetings included sharing up to date news of VAL401 dosing and sampling of patients.

During this quarter, ValiSeek also announced (9 November 2016) that it had received notification that a third US patent had been allowed by the US Patent Office covering the use of VAL401 in the treatment of lung adenocarcinoma.  Since then, the Company can announce that notification of a fourth US Patent Grant Allowance for VAL401 has been received.

This announcement contains inside information for the purposes of Article 7 of EU 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 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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