TIDMVAL
RNS Number : 0239Z
ValiRx PLC
12 December 2017
VALIRX PLC
("ValiRx", the "Company" or the "Group")
VALISEEK CLINICAL DEVELOPMENT UPDATE
"Positive Formal Data Release Pertaining to Disease Impact
from VAL401 Phase II Clinical Trial"
London, UK., 12 December 2017: ValiRx Plc (AIM: VAL), the
clinical stage biotechnology company, is pleased to provide a
positive update on the clinical progress of VAL401, the anti-cancer
compound developed by ValiSeek, the joint venture between ValiRx
and Tangent Reprofiling Limited.
Further to the release of pharmacokinetic data from the
completed Phase II clinical trial in Tbilisi, Georgia (as announced
on 28 September 2017), the Company is pleased to now announce the
positive formal data release pertaining to disease impact. The
results demonstrate that the VAL401 treatment has a statistically
significant improvement in Overall Survival ("OS") for patients
with non-small cell lung cancer compared to those receiving no
treatment.
This data has been summarised and published in our updated
information sheet available at:
http://www.valirx.com/in-the-news/valiseek-val401-novel-cancer-therapeutic-updated/
Scientific Summary:
All data collected during the clinical trial of VAL401 in
Tbilisi, Georgia, which completed earlier this year, has now been
fully verified and the database has been locked against further
modifications. The data analytics team at Ariana Pharma (the
company appointed to undertake clinical data analysis of the data
gathered during the trial) has received the full database and
started its formal analysis. Furthermore, Ariana Pharma is
characterising the best responders to VAL401 using their
proprietary KEM(R) (Knowledge Extraction and Management) advanced
artificial intelligence technology.
In addition to the data collected throughout and beyond dosing
of the VAL401 treated patients, historical data from the clinics in
Tbilisi has been collected in order to benchmark our patients.
These patients would have been eligible for the trial, but either
declined consent or were treated in the clinic at a time that
recruitment was not open in our trial. Although not a placebo
group, these patients provide a comparison group to indicate how
long our patients may have expected to survive without the VAL401
treatment. Data consisting only of date of first and last
chemotherapy prescription and date of death is available for all
untreated patients. This allows a valuable comparator group for
survival analysis.
Comparing the OS rates of treated patients to untreated patients
and measuring from the date that patients received their first
course of chemotherapy for non-small cell lung cancer until the
date of death, VAL401 treatment provides a statistically
significant (p = 0.0109 log likelihood ratio) improvement in
survival.
Further analysis of the other endpoints, including Quality of
Life, is underway at Ariana along with systematic scrutiny of
underlying factors. These dictate the response or non-response of
patients to treatment, using Ariana's KEM(R) platform. The use of
this technology aims to increase the chances of success in
subsequent trials through informed patient selection.
Commercial Summary:
Further to our announcement of 11 October 2017, we confirm that
the allowed US patent has now been fully granted with Number: US
9808462.
VAL401 has been tested in the above mentioned trial against
non-small cell lung cancer, the most common form of lung cancer.
The lung cancer market, with significant unmet medical need, is
projected to be valued at USD 7.9 billion in 2020 at a CAGR of
6.6%. The Company is in discussion with a number of large
pharmaceutical companies who are looking to fill their pipelines in
this therapeutic area.
Dr Suzy Dilly, CEO of ValiSeek, commented: "I am delighted to
confirm that our patients benefitted in overall survival, with the
other measures of disease impact still to be analysed and
presented. The team at ValiSeek, Ariana and ValiRx have been
instrumental in ensuring this data is presented and interpreted
fully and I look forward to updating the market with the next
report instalment".
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 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
END
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