TIDMVAL
RNS Number : 2179A
ValiRx PLC
28 September 2020
28 September 2020
("ValiRx", the "Company" or the "Group")
VAL201 Clinical Trial Update
Headline results demonstrate VAL201 has potential to be a safe
and well-tolerated drug
London, UK ValiRx (AIM:VAL) reports today that it has received
headline results from the recently completed Phase 1/2 clinical
trial of its lead asset VAL201, for the treatment of advanced
prostate cancer, held at University College Hospital (UCLH),
London.
The headline results, detailed below, provide a summary of the
top-level data of safety and tolerability as well as evidence for
disease impact as observed during the clinical trial. Full data and
details of from the clinical trial are expected to be received by
the Company by end Q4 2020.
Disease Impact - Overall Response Rate 54.5%
Evidence for positive disease impact has been measured using
PCWG2 (Prostate Cancer Working Group 2) guidelines. These industry
standard guidelines take into account both the primary tumour and
metastatic tumours alongside prostate specific antigen (PSA) levels
to assess whether the disease has progressed, or whether the
patient has responded and halted disease progression. These
guidelines provide a more comprehensive measure of disease impact
than just primary tumour imaging.
Of the 12 patients dosed with VAL201, 11 patients had sufficient
PCWG2-relevant data collected across multiple cycles. 6 of these 11
have been categorised as responding throughout treatment. That is,
when the treatment with VAL201 was halted for a defined reason,
whether or not the 6 standard cycles had been completed, these
patients showed no disease progression by PCWG2 criteria with
stable disease.
Safety and Tolerability - no Maximum Tolerated Dose declared
As the first clinical trial of VAL201, safety and tolerability
data are of paramount importance.
The headline safety and tolerability results demonstrated only
one dose-limiting toxicity event occurred. This was at a maximum
dose of 8 mg/kg, with the patient having raised blood pressure
(severe hypertension). Following treatment for the raised blood
pressure, the patient completed the remainder of the trial.
A Maximum Tolerated Dose has not been determined for VAL201, and
all doses remain available for further testing.
No deaths were reported in patients during the clinical
trial.
Further minor events listed as likely to be related to the
administration of VAL201 are: Injection site disorders in 11 out of
12 patients; fatigue (5/12); dyspepsia (1/12); muscle spasm (1/12);
hypertension (2/12); bradycardia (1/12).
Next Steps
During Q4 2020, the Company expects to receive the full Clinical
Study Report and will use the complete data to publish the results
on the National Institute of Health's (NIH) public database
ClinicalTrials.gov, as well as to produce research papers for
peer-reviewed publications.
The Company intends to share these results with potential
industry partners to evaluate all options for further clinical
development of VAL201.
Dr Suzy Dilly, Chief Executive Officer commented: "I am
delighted to be able to share these exciting results today, which
are an accumulation of a lot of work by the wider team, both within
and external to ValiRx. While considering these results it is
important to remember that this is only the first clinical trial
using VAL201, so this data has been generated using the utmost
caution in sequentially dosing patients. Nevertheless, the headline
results clearly demonstrate that VAL201 has the potential to be a
safe and well-tolerated drug. With this data in hand, future
studies will investigate optimal dosing strategies for VAL201 and
help confirm these early indications of a positive response
rate."
Professor Alan Boyd, Consultant Pharmaceutical Physician and
Medical Monitor for the study commented: "Development of effective
treatments with low-side effects for patients with prostate cancer
who have relapsed after radiotherapy is essential and will improve
the lives of patients during treatment. I am pleased to have
contributed to a project that has demonstrated such a good safety
and tolerability profile while giving the first indications of a
favourable effect on the patient's disease."
This announcement contains inside information for the purposes
of Article 7 of EU Regulation 596/2014.
For further information please contact:
ValiRx plc Tel: +44 (0) 20 7073
2628
www.valirx.com
Suzanne Dilly Suzanne.Dilly@valirx.com
Cairn Financial Advisers LLP (Nominated Tel: +44 (0) 20 7213
Adviser) 0880
Liam Murray / Jo Turner / Ludovico Lazzaretti
Peterhouse Capital Limited (Sole Broker) Tel: +44 (0) 20 7469
Duncan Vasey / Lucy Williams / Eran Zucker 0930
Optimum Strategic Communications Tel: +44 (0) 20 8148
Supriya Mathur/ Shabnam Bashir 3040
valirx@optimumcomms.com
About ValiRx
ValiRx accelerates the development of treatments in oncology and
women's health to improve patient lives. We provide the scientific,
financial and commercial framework to enable rapid translation of
innovative science into clinical development.
With our extensive and proven experience in research and drug
development, we select and incubate promising novel drug candidates
and guide them through an optimised process of development, from
pre-clinical studies to clinic and investor-ready assets.
Integrating science and business
We connect diverse disciplines across scientific, technical and
commercial domains, with the promise of achieving a more
streamlined, less costly, drug development process. We work closely
with our selected collaborators and leverage the combined expertise
required for science to advance.
Lead candidates from our portfolio are out-licenced or partnered
with investors through ValiRx subsidiary companies for further
clinical development and commercialisation.
https://www.valirx.com/
About VAL201
VAL201 is a short peptide being studied for the treatment of
prostate cancer. The peptide structure is inspired by the naturally
occurring androgen receptor, and is designed to intercept and
prevent the binding of the androgen receptor to SRC kinase - an
enzyme implicated in cancerous cell growth pathways. By preventing
the androgen-mediated activation of SRC kinase, VAL201 can
potentially prevent cancerous cell proliferation (or growth)
without interfering with other functions of either the androgen
receptor or SRC kinase. This precision method, mimicking a natural
process, proposes a high specificity of cancer treatment with a
lower side effect profile. VAL201 was licensed from CRT (part of
CRUK) in 2010 and developed through preclinical development into
this clinical trial in patients with advanced prostate cancer. The
study was held at University College Hospital (UCLH), London.
About the VAL201-001 clinical trial
The clinical trial: "A Phase I/II, Dose Escalation Study to
Assess the Safety and Tolerability of VAL201 in Patients with
locally Advanced or Metastatic Prostate Cancer and Other Advanced
Solid Tumours" opened to recruitment in December 2014 and closed in
January 2020.
Patients were scheduled for treatment of a once weekly injection
of VAL201 in 3 week cycles for a maximum of 6 cycles. A total of 12
patients received at least 1 dose of VAL201.
Patients were eligible if they were: Adult men (over the age of
18) with incurable locally advanced or metastatic prostate cancer
who had relapsed following radiotherapy treatment, are in 'watchful
waiting' or where a policy of intermittent hormone therapy had been
decided. Patients were expected to have no or only mild symptoms
relating to their prostate cancer. (ClinicalTrials.gov identifier:
NCT02280317)
About Prostate Cancer
Around 48,500 men are diagnosed with prostate cancer in the UK
each year[1]. In men, it is the most common cancer in the UK.
Prostate cancer is most common in older men. On average each year
35 out of 100 (35%) of new cases are in men aged 75 and over.
Caution regarding forward looking statements
Certain statements in this announcement, are, or may be deemed
to be, forward looking statements. Forward looking statements are
identi ed by their use of terms and phrases such as "believe",
"could", "should" "envisage", "estimate", "intend", "may", "plan",
"potentially", "expect", "will" or the negative of those,
variations or comparable expressions, including references to
assumptions. These forward-looking statements are not based on
historical facts but rather on the Directors' current expectations
and assumptions regarding the Company's future growth, results of
operations, performance, future capital and other expenditures
(including the amount, nature and sources of funding thereof),
competitive advantages, business prospects and opportunities. Such
forward looking statements re ect the Directors' current beliefs
and assumptions and are based on information currently available to
the Directors. While management believes that these forward-looking
statements are reasonable as and when made, there can be no
assurance that future developments affecting the Company will be
those that it anticipates.
Factors that could cause actual results to differ materially
from those in the forward-looking statements include risks relating
to unanticipated costs, liabilities or delays; failure or delays in
research and development programs; the safety and efficacy of the
Company's product candidates and the likelihood of clinical data to
be positive and of such product candidates to be approved by the
applicable regulatory authorities; unanticipated changes relating
to competitive factors in the Company's industry; risks relating to
the Company's capitalisation, resources and ownership structure,
the availability of sufficient resources for company operations and
to conduct or continue planned clinical development programs; the
outcome of any legal proceedings; risks related to the ability to
correctly estimate operating expenses; risks related to the ability
to project future cash utilisation and reserves needed for
contingent future liabilities and business operations; risks
related to the changes in market prices of the Company's ordinary
shares; the Company's ability to hire and retain key personnel;
changes in law or regulations affecting the Company; international,
national or local economic, social or political conditions that
could adversely affect the Company and its business; conditions in
the credit markets; risks associated with assumptions the Company
makes in connection with its critical accounting estimates and
other judgments.
Ends
[1]
https://www.cancerresearchuk.org/about-cancer/prostate-cancer/about
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
RNS may use your IP address to confirm compliance with the terms
and conditions, to analyse how you engage with the information
contained in this communication, and to share such analysis on an
anonymised basis with others as part of our commercial services.
For further information about how RNS and the London Stock Exchange
use the personal data you provide us, please see our Privacy
Policy.
END
MSCPPUBWBUPUGMM
(END) Dow Jones Newswires
September 28, 2020 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
