TIDMVAL
RNS Number : 9423B
ValiRx PLC
16 January 2018
VALIRX PLC
("ValiRx", the "Company" or the "Group")
VALISEEK CLINICAL UPDATE (VAL401)
"Positive Impact of Patient Quality of Life and Immune
Competency
in VAL401 Phase II Clinical Trial"
London, UK., 16 January 2018: ValiRx Plc (AIM: VAL), the
clinical stage biotechnology company, is pleased to provide an
update on the clinical progress and results of VAL401, the
anti-cancer compound developed by ValiSeek, the joint venture
between ValiRx and Tangent Reprofiling Limited.
Following on from the announcement on 12 December 2017 regarding
the overall survival results from the completed Phase II Clinical
Trial of VAL401 in Tbilisi, Georgia, in the treatment of late stage
non-small cell lung cancer, the Company is pleased to release
further positive data on the results from this trial. The data
analysed by Ariana, a leading digital health Company focused on
developing advanced therapeutic decision support systems, shows
that the VAL401 treatment has a measureable improvement on patient
quality of Life, in addition to a positive impact on the
disease.
The one page information sheet available on the website has now
been updated, and can be viewed at:
http://1cqi8a4dpf4p8okqjp35hmi5.wpengine.netdna-cdn.com/wp-content/uploads/2018/01/VS-Jan-2018-one-pager.pdf
Detailed technical reports are currently being prepared for
submission to the regulatory authorities. Subsequent data release
will be in the format of peer-reviewed publications in academic
journals to ensure that the data is subject to long-term
accessibility and will be available on publicly searchable
databases. Clinicaltrials.gov will be updated upon agreement with
the regulatory authorities of the Clinical Study Report.
Response for the treatment has been systematically characterised
using Ariana's KEM(R) (Knowledge Extraction and Management)
advanced Artificial intelligence technology to identify provide
positive relations between response and pharmacokinetic parameters
and between response and pre-treatment with particular
chemotherapies. This may be indicative of the potential for
combining VAL401 with these particular chemotherapies.
Progression Free Survival
Progression-free survival ("PFS") was defined as the length of
time between initiation of VAL401 treatment and a patient's removal
from the trial or death (whichever is sooner) and considered as a
comparison of responders to non-responders. In order to
characterize responders, the definition of the Overall Survival
("OS") was shortened to the length of time between the initiation
of VAL401 treatment and death.
PFS and OS are presented in the table below, with the time
represented as day zero and being the first day of VAL401
treatment. The mean values quoted represent an additional one month
or longer of PFS and OS after response to VAL401 treatment.
The "intention to treat" population incorporates all patients
under survival assessment; the "per protocol" population
incorporates all patients who received a minimum of 10 days dosage.
Responders were identified by Ariana's KEM(R) technology using
survival data.
PFS mean OS mean (range)
(range)
----------------------------- -------------- ----------------
Responders (n=3) 8.7 weeks 12.9 weeks
(7.1 - 11.6) (11.6 - 15.3)
----------------------------- -------------- ----------------
Non-responders, intention 2.5 weeks 3.9 weeks (0.4
to treat population (n=4) (0.4 - 4.7) - 7.4)
----------------------------- -------------- ----------------
Non-responders, per protocol 4.3 weeks 7.1 weeks (6.8
population (n=2) (4.0 - 4.7) - 7.4)
----------------------------- -------------- ----------------
These results identify an overall response rate in the per
protocol population of 60%.
Biochemical Response
Blood biochemistry was measured in all patients at regular
intervals during the on-trial period. This data was included in
Ariana's exhaustive data analysis and it was observed that the
White Blood Cell Count (WBC) in 3 patients increased during the
trial. Two of the responders were subject to a sustained increase
in WBC, and one non-responder increased WBC on trial initiation
before the WBC returned to baseline.
A WBC increase is indicative of increased immune system
activity. The increase seen during our trial suggests that VAL401
does not cause immune suppression, which is common in traditional
chemotherapies. It therefore makes it appropriate for considering
the testing of VAL401 in co-administration with Immuno-oncology
treatment.
Quality of Life data
Quality of Life questionnaires were carried out at regular
intervals while the patients were on-trial. Nineteen factors
improved from baseline to trial end in several patients. Other
factors improved briefly before returning to baseline as the
disease approached the time of progression. These included one
patient that reported improved appetite (and showed a bodyweight
gain throughout the trial), one patient reporting improvement in
depression and another an improvement in irritability. Two
responders reported an improvement in ability to take part in
leisure activities.
Ariana's KEM(R) systematic analysis of the Quality of Life
improvements identified relations providing further insight into
VAL401:
-- Multiple patients reported an improvement in pain, which on
comparison to pharmacokinetic parameters was linked to high
exposure to VAL401.
-- Improvement in fatigue was associated with lower exposure.
-- Patients regardless of responder status reported improvements
in Quality of Life measures suggesting palliative effects of VAL401
treatment. Responders additionally observed anti-cancer (survival)
benefit.
Dr Suzy Dilly, CEO of ValiSeek, commented: "This data advocates
the potential for VAL401 in treating very late stage cancer
patients in the palliative arena. It also advocates the potential
for VAL401, in the as yet untested combinations with, both
traditional chemotherapies and immune-oncology treatments.
Palliative stage patients could expect to see improvements in
symptoms with the added benefit of improved survival prospects.
This encouraging 60% overall response rate seen in this first
all-comer trial, provides a strong foundation for the next stage of
clinical testing. The measure of immune competency of the treated
patients was also a pleasingly unexpected addition to the results.
In sum, we are very excited to see such good response rate for a
condition with huge unmet medical need."
This announcement contains inside information for the purposes
of Article 7 of EU Regulation 596/2014, and the person who arranged
for release of this announcement on behalf of the Company was
George Morris, Chief Operations Officer.
***S ***
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 Tel: +44 (0) 20
(Nominated Adviser) 7213 0880
Liam Murray/Jo Turner/Richard
Nash
Beaufort Securities Limited Tel: +44 (0) 207
(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 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
About Ariana Pharma
Ariana(R) Pharma is a leading digital health Company focused on
developing advanced therapeutic decision support systems. Ariana's
innovative clinical data analysis and diagnostic testing solutions
help the healthcare sector better adapt patient treatments to
individual biological characteristics. Ariana's KEM(R) Artificial
Intelligence technology enables personalization of therapies,
improves the efficacy and safety of patient treatment, reduces
risks and drug development costs, and accelerates time to market.
KEM(R) is the only FDA - tested technology that systematically
explores combinations of biomarkers, producing more effective
biomarker signatures for precision medicine. Ariana has developed
Onco KEM(R), the most advanced, clinically tested, oncology
treatment selection system. Founded in 2003 as a spin - off of the
Institut Pasteur, Paris, France, the company opened a subsidiary in
the United States in 2012. Further information is available at
www.arianapharma.com
This information is provided by RNS
The company news service from the London Stock Exchange
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