Update re VAL301
("ValiRx", the "Company" or the "Group")
UPDATE RE VAL301
FOR THE TREATMENT OF ENDOMETRIOSIS
"ValiRx progresses VAL301 Clinical Development Plan"
London, UK., 04 July 2019: ValiRx Plc (AIM: VAL), the clinical stage biotechnology company, is pleased to announce that the Company's clinical team has signed an agreement to work with Aptus Clinical Ltd ("Aptus"), the UK based, clinical Contract Research Organisation ("CRO"), to effectuate a clinical development plan for VAL301 incorporating a Phase I/II study design concept in Endometriosis.
Aptus will be working with ValiRx on regulatory, technical and scientific areas, in order to bring VAL301 nearer to the clinic.
Endometriosis is a benign, oestrogen -dependent chronic condition, characterised by endometrial tissue growth outside of the uterus. Symptoms including heavy painful periods, pain with intercourse and infertility are often severe and are associated with a decreased quality of life for young women. The condition affects an estimated 1 in 10 women during their reproductive years, equating to approximately 176 million women worldwide*, posing a high economic burden.
VAL301 is derived from the same active pharmaceutical ingredient as VAL201, which is currently in a Phase I/II clinical trial where the compound has demonstrated safety and has been well tolerated. These positive results will be used to strengthen the clinical application of the development programme. Pre-clinical studies indicate that treatment with VAL301 should not affect bone density or fertility, two of the major problems associated with current medical treatments for endometriosis. ValiRx intends to develop VAL301 as a non-invasive, effective and better tolerated treatment for this debilitating condition.
Dr Satu Vainikka, CEO of ValiRx, commented: "Our agreement with Aptus represents an important stage in preparing the VAL301 compound for clinical study. I look forward to VAL301's future development and its potential to benefit women who suffer from this extremely painful condition".
Dr Steve McConchie, Co-founder & CEO of Aptus, added: "We are delighted to have been selected by ValiRx to work on the development plan options for VAL301 in endometriosis. We look forward to exploring some innovative opportunities with the team in order to optimise the programme delivery timelines and progress this important potential treatment rapidly to patients".
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:
Tel: +44 (0) 20 3008 4416
Dr Satu Vainikka, Chief Executive
Tel: +44 (0) 20 3008 4416
Tarquin Edwards, Head of Communications.
Tel: +44 (0) 7879 458 364
Cairn Financial Advisers LLP (Nominated Adviser)
Liam Murray / Jo Turner / Ludovico Lazzaretti
Tel: +44 (0) 20 7213 0880
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Novum Securities Limited
Tel: +44 (0) 20 7399 9400
Notes for Editors
Aptus is a UK based, clinical CRO with particular expertise in oncology, rare diseases and advanced (cell and gene) therapies. The company provides design, set-up, management and monitoring of early phase clinical trials. In addition, it supports clients with a range of specialist services that include quality management frameworks, clinical governance support and a number of digital solutions that facilitate data storage, analysis and visualisations.
Aptus are partners in iMATCH (innovate Manchester Advanced Therapy Centre Hub), a consortium of experts from industry, academia and the NHS, funded by Innovate UK. The iMATCH objective is to accelerate the safe and effective delivery of advanced therapies to increasing numbers of patients within the NHS. Aptus are also preferred suppliers to the Cell and Gene Therapy Catapult.
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 World 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.
Caution regarding forward looking statements
Certain statements in this announcement, are, or may be deemed to be, forward looking statements. Forward looking statements are identiﬁed by their use of terms and phrases such as ''believe'', ''could'', "should" ''envisage'', ''estimate'', ''intend'', ''may'', ''plan'', ''potentially'', "expect", ''will'' or the negative of those, variations or comparable expressions, including references to assumptions. These forward looking statements are not based on historical facts but rather on the Directors' current expectations and assumptions regarding the Company's future growth, results of operations, performance, future capital and other expenditures (including the amount, nature and sources of funding thereof), competitive advantages, business prospects and opportunities. Such forward looking statements reﬂect the Directors' current beliefs and assumptions and are based on information currently available to the Directors.
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