REG - ValiRx PLC - VAL201 Clinical Trial Update

ValiRxAnnouncement

28/09/2020 07:00

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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 (http://www.valirx.com/)
 Suzanne Dilly                                      Suzanne.Dilly@valirx.com

 Cairn Financial Advisers LLP (Nominated Adviser)   Tel: +44 (0) 20 7213 0880

 Liam Murray / Jo Turner / Ludovico Lazzaretti

 Peterhouse Capital Limited (Sole Broker)           Tel: +44 (0) 20 7469 0930

 Duncan Vasey / Lucy Williams / Eran Zucker

 Optimum Strategic Communications                   Tel: +44 (0) 20 8148 3040

 Supriya Mathur/ Shabnam Bashir                     valirx@optimumcomms.com (mailto: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/ (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 identified 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 reflect 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

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