07:00 Mon 16 Dec 2019
ValiRx PLC - VAL201 Update
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VAL201 UPDATE
"Positive Phase I/II data compiled"
As the Company anticipated in
The results appear, in advance of full analysis, to indicate that the VAL201 compound has a clear impact on patients with prostate cancer, as measured by PSA - evidence that is supported from tumour imaging (MRI and CT) in subjects. The compound has also shown it is very safe and has a high degree of tolerability, up to a dose that is in excess of the predicted dose and any practical therapeutic concentration.
The results, along with a full statistical and scientific analysis, will be submitted to the relevant regulatory authorities as is required, at which point the detailed results will be made publicly available. However, in the interim, it is intended that the trial's preliminary observations may be presented at various academic conferences, as part of the compound's ongoing reporting and analysis.
Scientific Summary:
· All data collected to date during the clinical trial of VAL201, is currently being reviewed and collated by the data analytics team.
· The data will be secured after it has been entered into the record, collated and verified, whilst some additional data is still to be collected from various providers, contractors and from patients and then entered into the record.
· Beyond the fundamental safety and tolerability endpoints for the trial, the study is providing accurate pharmacokinetic information about the uptake, distribution, metabolism and elimination of the compound in humans. As such, VAL201 continues to address its endpoints in its first-in-human study.
· A late-stage study designed to determine the overall effectiveness of VAL201 and the most effective therapeutic strategies for its use in disease management, is now possible. This late-stage study will be designed and set up, in parallel to the conclusion of the current early-stage Phase I/IIa trial.
VAL201 has been developed in collaboration with
Dr Satu Vanikka, CEO of
"With prostate cancer reported this month in an academic study as being the most common cancer in men in the
"I look forward to regulatory approval of the trial data being speedily reached and the opportunity of potentially demonstrating that VAL201 can address this widespread and often fatal disease in men."
Sources:
*https://www.bristol.ac.uk/news/2019/december/prostate-cancer.html
** Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries by Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A in CA: A
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.
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Notes for Editors
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