Last checked at 6 Sep 2018 07:00
VALIRX PLC
("ValiRx" or the "Company")
UPDATE ON CLINICAL DEVELOPMENT
London, UK., 06 September 2018: ValiRx Plc (AIM: VAL), the clinical stage biotechnology company, is pleased to provide an update on the successful developmental progress regarding its clinical programmes.
Both of the Company's clinical stage therapeutics continue to demonstrate significant potential for addressing unmet medical needs in oncology. The Company has global exclusive commercial rights with worldwide patent protection. The technologies and science originate from World class institutions.
VAL401
(Completed Phase II clinical trial of VAL401 as an oral treatment of late stage non-small cell lung adenocarcinoma)
Confirmation was received this week that Principal Investigators have approved and signed the Clinical Study Report and that the process of submission to and approval by the local ethics committees has commenced. Notification of receipt of the Clinical Study report was filed to the Ministry of Health in Tbilisi, before the end of July 2018 in accordance with regulatory expectations.
Commercial activity surrounding VAL401 has continued. Detailed discussions are in progress in respect to a pivotal Phase III Clinical Trial. Partners external to ValiRx and ValiSeek will have substantial input into the trial design, with first dosing anticipated next year.
VAL201
(VAL201 is currently in Phase I/II clinical trials for patients affected by hormone- sensitive and hormone-resistant prostate cancer.)
The VAL201 compound has demonstrated consistent high safety and tolerability, and signs of efficacy throughout its clinical study. A preliminary inspection of the clinical data derived from the original dosing regimen has been completed regarding all the subjects that have been treated to date. This inspection considered all dosing regimens. In summary, our preliminary observations highlight a dose-related impact on patients' physiology and chemistry, such as androgen PSA and various cell and protein turnover factors, which are important in the treatment of cancer. These are in line with anticipated outcomes as far as cancer reduction is concerned.
Dr Satu Vainikka, CEO of ValiRx, commented: "Our potential anti-cancer treatments collectively address unmet medical needs. Since the pharmaceutical industry is increasingly looking for novel new therapies in the oncology arena, I believe we are in a new and very exciting phase. VAL401 has demonstrated therapeutic efficacy, VAL201 is increasingly showing its therapeutic potential and our pre-clinical compounds and platform continue to progress along the value-chain and towards the clinic. We continue to look forward to the successful crystallisation of substantial value for patients and shareholders".
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: +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