TIDMVAL
RNS Number : 8402G
ValiRx PLC
30 November 2020
30 November 2020
("ValiRx", the "Company" or the "Group")
VAL201 Clinical Trial Full Data Results
Full dataset confirms VAL201 is a safe and well-tolerated drug
candidate
Company to host webcast for investors on 8 December 2020 at 2 pm
GMT
London, UK - ValiRx plc ("ValiRx", AIM:VAL), a clinical stage
drug development company, is pleased to report that it has received
the full dataset to be used for the Clinical Study Report from the
Phase 1/2 clinical trial of its lead asset, VAL201, for the
treatment of locally advanced or metastatic prostate cancer and
performed at University College Hospital (UCLH), London. This
expands the positive headline results announced on 28 September
2020.
The dataset provides a complete breakdown of the full data of
safety and tolerability as well as evidence for encouraging disease
impact as observed during the clinical trial. This data will be
used to formulate the Clinical Study Report and to report the
results on the www.clinicaltrials.gov database. Additional detailed
analysis of the results will form the basis of peer-reviewed
journal publications.
The full dataset is available to download on the Company
website, https://www.valirx.com/our-pipeline/val201 .
Key details of the findings:
Recruitment Criteria
-- Twelve patients were recruited according to the criteria of
having incurable, locally advanced or metastatic prostate cancer
with rising PSA[1] (Prostate-Specific Antigen) on three consecutive
samples and absent or very mild prostate cancer-related
symptoms.
-- The demographics and a detailed breakdown of the patients
recruited is provided in the download.
Disease Impact
-- The headline results released in the Company announcement on
28 September 2020 highlighted the response rate of 54.5%, where
response was confirmed by a lack of disease progression by PCWG2
(Prostate Cancer Working Group 2) criteria. The dataset now
received provides the detailed breakdown of this by providing both
the PSA modulation afforded by the treatment, and the tumour
response.
-- The PSA data, a recognised surrogate of disease progression,
shows two patients seeing a decrease in PSA during their treatment
period, one of which maintained the decrease throughout the trial.
An analysis of the doubling time of patients shows a statistically
significant (p<0.05, two-tailed Wilcoxon Signed-Rank test for
paired samples) increase in PSA doubling time comparing
pre-treatment doubling time to post-treatment doubling time. The
PSA doubling time would be expected to be unchanged if the
treatment was having no impact, so an increase in doubling time
demonstrates a slowing rate of growth of PSA levels.
-- The tumour response data demonstrates that patients did not
have an increase in metastatic lesions during the treatment period,
and that metastatic lesions already present did not grow at all in
two out of three patients, suggesting a positive influence of
VAL201 on the disease.
Safety and Tolerability
The further breakdown of the safety data confirms the well
tolerated nature of the drug.
Additionally, the initial pharmacokinetic analysis supports the
safety profile in confirming the drug is processed and cleared from
the body in the manner expected.
The Company expects to publish the data on the National
Institute of Health's (NIH) public database ClinicalTrials.gov, as
well as produce research papers for peer-reviewed publications.
Investor Webcast
ValiRx will host a webcast for investors on Tuesday, 8 December
2020 at 2pm GMT to discuss the findings of the study.
-- Prior to the webcast, questions can be submitted online to questions@valirx.com
-- During the webcast, questions can be submitted through the webcast link below.
To participate, please click on the link below at the designated
time:
https://webcasting.brrmedia.co.uk/broadcast/5fc12476b19325729a9d841f
The webcast will be available on demand following a link on the
Company's website after the broadcast. This webcast replaces the
usual monthly Q&A publication, and a written summary of
questions with answers will be provided after the event.
Dr Suzy Dilly, Chief Executive Officer commented: "This data
demonstrates the potential of VAL201 for further development
towards a treatment for patients with prostate cancer. Providing
the data breakdown to support and explain the headline numbers is a
crucial step and allows us to delve further into analysis of the
results. The highly encouraging 54.5% response rate remains
unchanged and being able to interrogate the data in more detail
allows us to explore the possibilities for optimising the treatment
through future trial with partners.
"We continue to share the dataset with potential industry
partners who expressed an interest after the headline results were
released in September 2020, and I look forward to the discussions
that I am confident will arise as we evaluate all options for
further clinical development. We would like to thank the team for
their hard work and our shareholders for their support."
This announcement contains inside information for the purposes
of Article 7 of EU Regulation 596/2014. The Directors of the
Company take responsibility for this announcement.
Ends
For further information please contact:
ValiRx plc Tel: +44 (0) 2476 796496
www.valirx.com
Suzanne Dilly, CEO 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 plc
ValiRx accelerates the development of treatments in oncology and
women's health to improve patient lives. We provide the scientific,
financial and commercial framework towards enabling 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 aim 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-licensed 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 as a potential treatment
for 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[2]. 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.
[1] The PSA test is a blood test used primarily to screen for
prostate cancer. The test measures the amount of prostate-specific
antigen (PSA) in the blood. PSA is a protein produced by both
cancerous and noncancerous tissue in the prostate gland.
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