ValiRx secures 'substantial amendment' to VAL201 clinical trials

Clinical stage biotechnology company ValiRx updated the market on ‘VAL201’ on Thursday, confirming that, based on clinical results, a “substantial amendment” to the clinical trial protocol had received regulatory approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) and the research ethics committee.

The AIM-traded firm said that, following the approval of the amendment, prostate cancer specialist Dr Mark Linch had been appointed as principal investigator to the clinical trial team at University College London Hospital (UCLH).

Dr Linch was an honorary senior lecturer at the University College London (UCL) Cancer Institute, where he was leading the uro-oncology biology group, and was also a consultant medical oncologist specialising in the treatment of prostate and bladder cancer at UCLH.

ValiRx confirmed that Dr Rebecca Kristeleit was continuing with the study as chief investigator.

It said that to date, the results generated by the trial - aided by sizable analytical method developments - had shown that safe toxicological limits could be significantly elevated and applied to much higher levels in humans than was suggested by the preclinical studies.

The approval given to relax the restrictions previously applied to the trial would mean that a more effective use of VAL201 could be achieved with respect to concentration and timing, and regarding increased flexibility in the administration of the drug, the board explained.

Additionally, it said the amendment relating to dosing strategies meant that - in light of accumulated clinical data - the company would be able to develop further protocols.

Those would be designed to evaluate a range of defined therapeutic approaches that were to be tested against each other, to determine the most effective approach in terms of disease management, cost effectiveness and patient welfare in further clinical trials.

The protocols would be the precursor to seeking approval to conduct trials aimed at gaining sufficient data to secure partnering and then marketing approval application.

ValiRx reported that the trial thus far had met all of its primary and secondary endpoints, with the safety and tolerability results continuing to be acceptable, and further evidence of the compound's positive effect in reducing the progress of prostate cancer witnessed.

The data from the trial was currently being collated for examination by independent third party experts.

ValiRx said the approval of the amendment further validated its clinical development throughout VAL201's first-in-human trial.

Further information connected to the data, and the results and findings from the trial, would form the basis of a report outlining the compound's clinical profile and behaviour, which would be published in due course.

“This substantial amendment has taken a lot of effort from the whole team both internal and by all our service providers to achieve,” said ValiRx chief operating officer Dr George Morris.

“The most gratifying thing is that our original pre-clinical experimental data has held up well and been vindicated throughout the whole of this first-in-human trial.

“Now, as the trial is delivering an extensive and positive output, it is also providing practical information back to the trialling of VAL201, so that the next stage of clinical development, in which we will endeavour to show how effective the compound actually is, can be entered into with confidence and support from all those involved.”