ValiRx journey of bringing closer to market its leading anti-cancer therapeutic VAL201 for patients with hormone-sensitive and hormone-resistant prostate cancer, took a step ahead as the news from an independent analysis data shows a reduction of PSA correlated to time on the Phase l/ll clinical trial.
This represents an initial formal statistical analysis of the VAL201 clinical data conducted by Dr Wilson Caparrós-Wanderley, an independent statistical consultant. This 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 noted in it’s announcement.
Furthermore, the company pointed out that this analysis reveals that volunteers treated with VAL201 display a statistically significant correlation for reductions over time in the amount of Testosterone and Prostate Specific Antigen (“PSA”), both of which are commonly-used markers for disease progression in prostate cancer.
The data further confirms that VAL201 has no statistically significant adverse trends across liver or kidney function, and has no impact on cardiac rhythm in the patients either, this data further reinforces the continuation of the good safety and tolerability data emerging from the trial, the company said.
Dr Satu Vainikka, CEO of ValiRx, 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. Effectively, the more a patient takes VAL201, the more a patient’s PSA will decrease”.