TIDMVAL
RNS Number : 7353L
ValiRx PLC
10 September 2019
VALIRX PLC
("ValiRx", the "Company" or the "Group")
VAL201 UPDATE
"ValiRx announces that in addition to pharmacokinetic and
toxicology data, clinical trial results show VAL201 behaves as
predicted in reducing prostate cancer progression"
London, UK., 10 September 2019: ValiRx Plc (AIM: VAL), the
clinical stage biotechnology company, today announces that its lead
therapeutic compound, VAL201, has thus far and continues to meet
all the published endpoints in its first-in-human study. Following
the announced allowance of a substantial amendment in March 2019,
the later stages of the trial, where subjects are being given
therapeutic and supra-therapeutic concentration of VAL201,
continues to demonstrate a safe and well tolerated profile. It
should be noted that this is cumulative information and the fact
that the compound continues to show a toxicological profile at and
above clinical concentration is significant.
Beyond the fundamental safety and tolerability endpoints for the
trial, the study has provided clear pharmacokinetic information
about the uptake, distribution, metabolism and elimination of the
compound in humans. The data supports and confirms the findings
from preclinical and the earliest stages of human studies and in
part explains the reduction in prostate cancer progression as
measured by PSA - evidence that is supported from tumour imaging
(MRI and CT) in subjects.
The effects of the compound on cancer is related to the tumour's
exposure to VAL201, and as expected from the underlying mechanism
of action, is a complex relationship to the administered dose. The
various amendments to the dosing protocol have allowed this effect
to be more fully explored. Further analysis of collected
pharmacodynamic samples is progressing and the data is expected to
build on this positive outcome to date. The full data set is
currently being reviewed and collated. Additional data surrounding
the possibility of an effect on metastatic tumour lesions is being
collated in the few subjects exhibiting such tumours. Such an
effect has been seen preclinically and hints are being
observed.
The final stages of this first in-human study has provided the
information needed to construct a protocol for the late stage trial
directed at determining effective dosing regimes for clinical use
and will explore the full extent of the compound's utility in
clinical practice.
This phase I/II trial will be finalised as expected from a
regulatory viewpoint while the new VAL201 confirmatory trial is
developed and aimed at validating the most effective treatment
regime and its particular use in clinical practice. Data relating
to the pharmacology, pharmacokinetics and pharmacodynamics will be
published as it is collated, verified and submitted.
VAL201 has been developed in collaboration with Cancer Research
(CRUK) and is a decapeptide with potential in treating
hormone-dependent and hormone-independent prostate cancer,
currently a poorly served multi-billion dollar commercial
market.
Dr Satu Vanikka, CEO of ValiRx Plc, commented:
"We are delighted that our Phase I/II trial of VAL201 has met
its endpoints very well and that we are now able to use our peptide
in demonstrating the efficacy of the VAL201 compound as a
therapeutic product that has a large role to play in dealing with
what is a nasty set of conditions in a better and more patient
friendly way."
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/ Ludovico
Lazzaretti
Novum Securities Limited 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 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
identi ed 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 re ect the Directors' current beliefs
and assumptions and are based on information currently available to
the Directors.
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
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of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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