TIDMVAL
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.
*** 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
Mark Treharne, Corporate Development Tel: +44 (0) 7736
Manager 564 686
mark.treharne@valirx.com
Cairn Financial Advisers LLP Tel: +44 (0) 20 7213
(Nominated Adviser) 0880
Liam Murray / Jo Turner
Northland Capital Partners Tel: +44 (0) 203
Limited (Joint Broker) 861 6625
Patrick Claridge / David Hignell
(Corporate Finance)
John Howes / Abigail Wayne
(Broking)
Beaufort Securities Limited Tel: +44 (0) 207
(Joint Broker) 382 8300
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.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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