ValiRx PLC Update on Clinical Development (9196Z)
September 06 2018 - 1:00AM
UK Regulatory
TIDMVAL
RNS Number : 9196Z
ValiRx PLC
06 September 2018
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.
*** ENDS ***
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 Tel: +44 (0) 20 7213 0880
Adviser)
Liam Murray/Jo Turner/Richard Nash
Novum Securities Limited (Broker) Tel: +44 (0) 20 7399 9400
Colin Rowbury
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
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
RESFKPDQFBKDQCK
(END) Dow Jones Newswires
September 06, 2018 02:00 ET (06:00 GMT)
Valirx (LSE:VAL)
Historical Stock Chart
From Apr 2024 to May 2024
Valirx (LSE:VAL)
Historical Stock Chart
From May 2023 to May 2024