Business
Update on VAL201 & VAL301 Development Progress
Update on VAL201 & VAL301 Development Progress.
About this update from Valirx Plc
[{"type":"text","content":"\n \nRNS Number : 5129T ValiRx PLC 21 March 2019 \n\n \n \nVALIRX PLC\n(\"ValiRx\" or the \"Company\")\n \nUPDATE ON VAL201 & VAL301 CLINICAL AND \nPRE-CLINICAL DEVELOPMENT PROGRESS.\n \nLondon, UK., 21 March 2019: ValiRx Plc (AIM: VAL), the clinical stage biotechnology company, is pleased to provide an update on the development of its therapeutic drugs, VAL201 and VAL301 regarding their clinical and pre-clinical progress.\n \nVAL201\nThe Company's leading anti-cancer therapeutic, VAL201, is a peptide with a unique mechanism of action, which was first developed by academics partly with support from Cancer Research UK. It is currently in a Phase l/ll Clinical Trial at University College London Hospital (\"UCLH\") for the treatment of advanced prostate cancer and potentially other indications of hormone-induced unregulated growth.\n \nValiRx have established that VAL201 is safe and well tolerated at doses of up to 4mg/kg and the Company can report that it has seen primary evidence of the drug's activity in prostate cancer.\n \nBased on these results, the MHRA approved an extension to the trial (announced 18/12/17), allowing for an intra-patient dose escalation of up to 16mg/kg. This segment of the trial is in the concluding stages of its Phase l/ll (announced 17/10/18) and is progressing with patients to establish the maximum tolerated acute dose in Humans (MTD). This part of the study is also further establishing potential efficacy levels and pharmacokinetic / pharmacodynamic profiles as well, providing supporting information with respect to the optimal therapeutic regimes to be tested in the subsequent late stage clinical trials. \n \nAn interim inspection of the trial's output indicates that the compound is and continues to perform as predicted from the pre-clinical findings.\n \nOn conclusion of the current Phase l/ll trial, the full data set will be analysed by third-party experts and the compound's profile and behaviour will be published.\n \nThe completion of the trial is a mandatory milestone prior to permission being given for further pre-market authorisation efficacy studies (Phase II/III).\n \nAfter reaching a conclusion based upon analysis of the results from this dose-ranging study, the Company will then decide whether to seek a p...