Business
re: VAL201 Clinical Trials
re: VAL201 Clinical Trials.
About this update from Valirx Plc
[{"type":"text","content":"\n \nRNS Number : 5685Z ValiRx PLC 18 December 2017 \n\n \n \nVALIRX PLC\n(\"ValiRx\" or the \"Company\")\n \n ENHANCEMENT OF THE VAL201 DOSE ESCALATION CLINICAL STUDY\n \n\"Approval received from the UK Medicines and Healthcare Products Regulatory Agency (\"MHRA\") \nand the Research Ethics Committee (\"REC\")\"\n \nLondon, UK., 18 December 2017: ValiRx Plc (AIM: VAL), the clinical stage biotechnology company, is pleased to announce that the Company has received approval from the MHRA and REC for the Company to expand its VAL201 trial for the Phase I/II Dose Escalation Study in Patients with Locally Advanced or Metastatic Prostate Cancer and other Advanced Solid Tumours.\nVAL201 has demonstrated consistently high safety and tolerability, as well as preliminary effectiveness throughout the clinical study. Following the successful completion of this stage one of clinical development, with no serious drug related adverse events noted, the MHRA and REC have accepted the Company and clinical team's request for this escalation to the study. This approval allows for a substantial increase in the dose of VAL201 being administered to patients, thereby allowing treatment to more speedily reach its full therapeutic potential and potential anti-cancer impact. Further analysis will be provided in due course following a more comprehensive evaluation of the data. \nThis regulatory approval permits ValiRx to;\n· To substantially raise the dosing level in patients in order to reach therapeutic levels and reduce disease progression; \n· To assess at what stage in disease development the compound can be most effectively deployed in subsequent, larger, outcome-oriented clinical trials; and\n· To determine which route and with whom to take the project to its next stage - by the Company or with a partner.\nVAL201 has the potential to target hormone induced oncological conditions and abnormal growths, including prostate, breast and ovarian cancers as well as endometriosis. VAL201 is currently in Phase I/II clinical trials at UCLH for prostate cancer. The compound has also shown effects against Endometriosis in pre-clinical studies. The VAL201 treatment is differentiated from current advanced p...