ValiRx PLC re: VAL201 Clinical Trials (5685Z)
December 18 2017 - 2:00AM
UK Regulatory
TIDMVAL
RNS Number : 5685Z
ValiRx PLC
18 December 2017
VALIRX PLC
("ValiRx" or the "Company")
ENHANCEMENT OF THE VAL201 DOSE ESCALATION CLINICAL STUDY
"Approval received from the UK Medicines and Healthcare Products
Regulatory Agency ("MHRA")
and the Research Ethics Committee ("REC")"
London, UK., 18 December 2017: ValiRx Plc (AIM: VAL), the
clinical stage biotechnology company, is pleased to announce that
the Company has received approval from the MHRA and REC for the
Company to expand its VAL201 trial for the Phase I/II Dose
Escalation Study in Patients with Locally Advanced or Metastatic
Prostate Cancer and other Advanced Solid Tumours.
VAL201 has demonstrated consistently high safety and
tolerability, as well as preliminary effectiveness throughout the
clinical study. Following the successful completion of this stage
one of clinical development, with no serious drug related adverse
events noted, the MHRA and REC have accepted the Company and
clinical team's request for this escalation to the study. This
approval allows for a substantial increase in the dose of VAL201
being administered to patients, thereby allowing treatment to more
speedily reach its full therapeutic potential and potential
anti-cancer impact. Further analysis will be provided in due course
following a more comprehensive evaluation of the data.
This regulatory approval permits ValiRx to;
-- To substantially raise the dosing level in patients in order
to reach therapeutic levels and reduce disease progression;
-- To assess at what stage in disease development the compound
can be most effectively deployed in subsequent, larger,
outcome-oriented clinical trials; and
-- To determine which route and with whom to take the project to
its next stage - by the Company or with a partner.
VAL201 has the potential to target hormone induced oncological
conditions and abnormal growths, including prostate, breast and
ovarian cancers as well as endometriosis. VAL201 is currently in
Phase I/II clinical trials at UCLH for prostate cancer. The
compound has also shown effects against Endometriosis in
pre-clinical studies. The VAL201 treatment is differentiated from
current advanced prostate cancer therapies, by not including
complete and general androgen hormone deprivation.
The molecule is a peptide that inhibits the interaction between
the androgen receptor and/or the oestrogen receptor complex with
Src Kinase complex Domain 3. This very specific mode of action has
been shown in pre-clinical studies to provide a potent therapeutic
benefit with fewer side effects compared to the standard hormone
therapy. VAL201 is potentially and uniquely able to treat prostate
cancer without many of the other debilitating side effects
associated with other therapies.
The Prostate cancer market is expected to rise to $8.2 billion
in 2023 and the endometriosis market to $2billion by 2025. (Global
Data)
ValiRx retains control of all commercial rights to the compound
and maintains an extensive patent portfolio covering the compound
and its use and development.
Dr Satu Vainikka, CEO of ValiRx, commented: "Successfully
reaching the endpoints in VAL201 clinical studies and receiving the
approval for the acceleration of the trial and to substantially
escalate the dose, is a pivotal and substantial breakthrough for
our lead compound. Since VAL201 has demonstrated disease
stabilisation, with a lower dose than was predicted, we anticipate
that by increasing the dosage we will be able to see further
anti-cancer activity. This accelerated study will speed-up the
human development of the compound and by doing so, it will save
both time and money. Most importantly, this potential treatment
will more speedily meet the needs of those patients currently
under-served by existing therapies. The pharmaceutical industry is
increasingly looking for novel new therapies in the oncology arena.
We are entering a new and very exciting phase, which should result
in the crystallisation of substantial value".
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 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
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