TIDMVAL
RNS Number : 0182S
ValiRx PLC
28 September 2017
ValiRx Plc
("ValiRx" or the "Company")
VALISEEK CLINICAL DEVELOPMENT UPDATE
"First Verified Data Release from VAL401 Phase II Clinical
Trial"
London, UK., 28 September 2017: ValiRx Plc (AIM: VAL), the
clinical stage biotechnology company, is pleased to provide a
positive development update on the clinical development of the
joint venture between ValiRx and Tangent Reprofiling Limited.
ValiSeek was formed to progress the novel cancer treatment drug,
VAL401, into Clinical Efficacy trials for the treatment of lung
cancer and other oncology indications. First dosing in the Phase II
clinical trial commenced in October 2016.
This update provides the first formal release of verified
clinical data emerging from our trial in Tbilisi, Georgia. As
reported in June 2017, we closed entry to the trial to new
patients, and have since collated, verified and analysed the data
collected over the first 2 weeks of all patients.
ValiSeek announces that the dosing portion of the trial is
complete, with the process of final data collection, regulatory
submissions for trial completion and finally for data analysis, is
now underway.
First results
The major results from this period include the pharmacokinetic
measurements recorded for each patient after a single 2 mg dose of
VAL401. This is carried out by a blood measurement of the active
pharmaceutical ingredient in VAL401, Risperidone, and the blood
measurements of the known by-product, or metabolite, of
Risperidone, 9-hydroxy-Risperidone.
This analysis has revealed some significant and interesting
differences between the absorption and subsequent metabolism of the
conventionally formulated Risperidone, which is in line with
expectations for our unique formulation. Importantly, we have
demonstrated that this patient population, biologically interacts
with the Risperidone in VAL401 to produce 9-hydroxy-Risperidone as
expected, demonstrating suitability of our proposed treatment
paradigm, as well as demonstrating that our formulation is
compatible with drug absorption and behaviour.
The absolute values in this pharmacokinetic analysis allow us
great confidence in our future studies, as the blood levels, even
at the lowest 2 mg dosage are sufficient to mirror the doses used
in the pre-clinical testing models. As 2 mg doses have been shown
to be broadly safe and tolerated in this patient population, this
has been nominated as the preferred dose going forwards.
Commercial
ValiSeek CEO, Dr Suzanne Dilly will be attending the Bio-Europe
bio-partnering conference in Berlin in November 2017 in order to
partake in one to one meeting with other delegates to discuss these
emerging results.
Dr Suzy Dilly, CEO of ValiSeek, commented: "It is gratifying to
be able to share this early trial data release, and in particular
to be able to confirm anticipated dosing levels in preparation for
the next trial. The analytical databases are now being continuously
populated, and I anticipate analysis from this final database to be
available, on schedule, before year end."
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
Dr Suzy Dilly, Chief Scientific 3008 4416
Officer 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 novel cancer
treatment drug, VAL401, through its remaining pre-clinical
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 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 company news service from the London Stock Exchange
END
RESBLGDCDBDBGRR
(END) Dow Jones Newswires
September 28, 2017 02:00 ET (06:00 GMT)
Valirx (LSE:VAL)
Historical Stock Chart
From Mar 2024 to Apr 2024
Valirx (LSE:VAL)
Historical Stock Chart
From Apr 2023 to Apr 2024