logo-loader

ValiRx making progress on several fronts

Last updated: 14:05 10 Mar 2016 GMT, First published: 18:05 10 May 2016 BST

shutterstock_327930536
Progress of the VAL401 compound received a boost last month as Valiseek received a US patent...

Life sciences group ValiRx Plc (LON:VAL) is making good progress as it continues to run its lead candidate through the clinical trial process to treat prostate cancer and results so far have been positive.

The same drug -  VAL201-  has also been shown to have a potential use to treat a women’s' infertility condition called endometriosis and it has now been reformulated as VAL 301 to that end.

This  is another big potential string to the bow since the endometriosis market is forecast to be worth US$1.3bn by 2017 and there are estimated to be 170mln sufferers worldwide. The firm's other main drug - VAL401 - for non-small cell lung cancer - is also forging ahead and manufacturing has now begun ahead of a phase II clinical trial, which will assess efficacy, safety and tolerability.

VAL 201 study to be expanded

VAL201 is currently in a phase I/II dose escalation study to assess safety and tolerability of the drug for prostate cancer and other solid tumours.

The early part of ValiRx’s phase I/II study was designed assess the safety and tolerability of VAL201 rather than efficacy.

The trial has been extended after discovering the treatment appears to be working at lower doses than predicted, the company said in January.

Computerised tomography (CT) imaging revealed ‘disease stabilisation’ and a reduction in prostate specific antigen (PSA) progression in the majority of patients.

Same story for VAL401

The firm has also told investors it is set to expand its clinical trial of lung cancer drug VAL 401 to a third site in Georgia.

A second clinic in Tbilisi, Georgia, has just started recruiting patients, but ValiRx now wants to utilise the City’s Research Institute of Clinical Medicine as a third site. 

“The amendment for preliminary datalock is important as it allow us both to access early data from the trial and to conduct a robust analysis of the early safety, tolerability and pharmacokinetic data, but without compromising the quality of life and survival data that will continue to be gathered".

Using different clinics will provide the optimal team for the company's trial, she added.

It comes after the group reported encouraging early findings and that the first patient had been dosed, with approval to begin dosing a second approved.

A low-risk, high-return investment, says analyst

Investors of life sciences firm ValiRx Plc (LON:VAL) get an awful lot for their money, according to analysts at Beaufort.

Rating the stock at ‘speculative buy’ with a target price of 6.0p, Beaufort said the clinical stage cancer therapeutics company operates at a low-risk, high return model.

Beaufort said ValiRx is shareholder friendly as it seeks to partner or out-licence with a view to crystallising value, before reaching the costlier phases of development.

“It routinely provides shareholders with tangible progress between modest funding rounds, the latest of which now finances its two lead candidates with respect to additional patient/centre recruitment, trial dosing and product manufacturing out to September,” Beaufort analysts Barry Gibb and Andy Senga said.

“Comparisons with both peer groups with similar clinical portfolios, or early stage partnership deals with big pharma seeking entrance into such therapeutic areas, suggests a significant valuation gap has opened.”

New patents in Japan and the USA

In October, the company said its technology had been further endorsed with the award of new patents in Japan and the US for compounds VAL201 and VAL401.

VAL201 has received a patent in Japan means it now has patent protection in Japan, Europe and Australia and USA, with further patents pending in significant markets across the rest of the world.

Meanwhile, joint venture ValiSeek Limited between ValiRx and Tangent Reprofiling Limited has been told that a third US patent has been granted for VAL401 for treating pancreatic adenocarcinoma.

The group under the microscope..

ValiRx as a group has three divisions. ValiPharma is the drug development side, which is developing the candidate VAL 201 for prostate cancer and potentially endometriosis.

ValiFinn is the biomarkers and diagnostic development division, while Valiseek is its joint venture with drugs firm Tangent Reprofiling, which was formed in 2014 to advance the drug VAL401 through its remaining preclinical development and towards Phase II trials for lung cancer and other cancers.

Candidates and the pipeline

Put simply VAL 201  works by stalling tumour cell growth, while leaving DNA processes unaffected.

The Phase I part of the trial is, in effect, complete, as what the firm described as "a major hurdle" was overcome, namely, that no serious adverse affects were shown on humans.

Now the work will move towards in phase II to looking at the effects of the drug so an all-important efficacy profile can be drawn up, ahead of hopefully forming a  new drug, though the firm has not set a specific timeline of when that stage will be reached.

The excellent safety record, along with pre-clinical data, has now persuaded the firm to design first human trials for testing the efficacy of VAL 201 for endometriosis.

What is endometriosis?

The condition sees undercontrolled growth of the womb's lining and causes great pain and infertility in many women.  There are numerous types of the condition and it is said to affect 10% of women at some point at child-bearing age but is hard to diagnose.  VAL201 can moderate the effects of the condition.

What is VAL401?

ValiRx's other main candidate -  VAL401-  is a reformulated version of an anti-psychotic Risperidone and after pre-clinical work, is now being prepared for a phase II efficacy trial for treating non-small-cell lung adenocarcinoma -  the most common form of the disease, accounting for 90% of all lung cancers.

For an idea of scale, one report in January said the global market for the disease was US$4.9bn in 2014 and is anticipated to expand by 12.1% from 2015 to 2023 to reach an eye-watering US$15.1bn in 2023.

Results for the six months to end June

Due to the heavier expenditure on the 201 and 401 drugs, losses rose 55% to £2.4mln (£1.56mln) in the six months to June.

In September this year, ValiRx raised £1.2mln in a placing and set up a £3.75mln convertible loan facility.

FTSE rises ahead of Easter weekend, JD Sport gains on upbeat outlook -...

The FTSE 100 gained on the final morning of this shortened Easter trading week. Festive cheer was limited though, as Thames Water confirmed shareholders would not provide it with a £500 million rescue package, prompting speculation over the London supplier’s future. On a more positive...

59 minutes ago