201 Data from 2018 being now tested on Humans!25 Sep 2020 07:42
UPDATE ON VAL201 CLINICAL TRIAL
"Positive Effect on Cancer Patients"
"Evidence revealed of decrease in prostate cancer biomarker PSA, related to dosing with VAL201"
London, UK., 10 December 2018: ValiRx Plc (AIM: VAL), the clinical stage biotechnology company, is proud to announce that independent analysis of VAL201 data shows 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.
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' (developed by M. Friedman in 1937) and the most up-to-date statistical method, 'Repeated Measures Multiple Correlation Analysis' (refined by Bakdash and Marusich in 2017).
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. Furthermore, with 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.
In addition to the independent analysis, the pharmacokinetics information collected from the clinical evaluation of ValiRx's more recent patients, shows that ValiRx is addressing the protocol's primary and secondary endpoints - as well as all the exploratory tertiary end points.
Further information about the endpoints is to be found posted on the NIH website, www.ClinicalTrials.gov, under: 'Dose Finding Safety Study of VAL201 in Cancer Patients (VAL201-001)'.