LONDON (ShareCast) - (Sharecast News) - Clinical stage biotechnology company ValiRx announced on Monday that independent analysis of VAL201 data showed a "statistically significant" dose dependant response in the reduction of PSA correlated to time on the Phase l/ll clinical trial, involving patients with hormone-sensitive and hormone-resistant prostate cancer.
The AIM-traded firm said it represented an initial formal statistical analysis of the VAL201 clinical data conducted by Dr Wilson Caparrós-Wanderley, an independent statistical consultant.

That was undertaken using a non-parametric approach - both the well-established 'Friedman Test', and the most up-to-date statistical method, 'Repeated Measures Multiple Correlation Analysis'.

ValiRx said the analysis revealed that volunteers treated with VAL201 displayed a "statistically significant correlation" for reductions over time in the amount of testosterone and prostate specific antigen (PSA), both of which were commonly-used markers for disease progression in prostate cancer.

The data further confirmed that VAL201 had no statistically significant adverse trends across liver or kidney function.

Additionally, the company said that with no impact on cardiac rhythm in the patients either, the data further reinforced the continuation of the good safety and tolerability data emerging from the trial.

On top of the independent analysis, the pharmacokinetics information collected from the clinical evaluation of ValiRx's more recent patients showed that the company was addressing the protocol's primary and secondary endpoints, as well as all the exploratory tertiary endpoints, the board said.

"I am delighted to receive this analysis from an external expert, showing that VAL201 is having a positive and desired effect on prostate cancer patients' disease markers," said ValiRx chief executive officer Dr Satu Vainikka.

"Effectively, the more a patient takes VAL201, the more a patient's PSA will decrease."

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