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Re: VAL201 - Filing of Phase IB Clinical Trial
Re: VAL201 - Filing of Phase IB Clinical Trial.
About this update from Valirx Plc
[{"type":"text","content":"\n \nRNS Number : 6021P ValiRx PLC 03 October 2013 \n\n \n \n3 October 2013\n \nValiRx Plc\n(\"ValiRx\" or the \"Company\")\nRe: VAL201 - Filing of Phase IB Clinical Trial to be undertaken at\nUniversity College London Hospital \"(UCLH\")\nValiRx Plc (AIM: VAL), a life science company with a focus on cancer therapeutics for personalised medicine, is pleased to announce that the Company has filed a Phase IB/dose escalation study (\"Trial\") for VAL201, ValiRx's leading anti-cancer therapeutic. This represents an ethical and Research & Development committee filing that is needed before approval to proceed in cancer cases is granted. The Trial will be directly a First in Man with real patients and will not require healthy volunteers. Therefore the Company expects to obtain significant results rapidly. \n \nThe clinical unit at University College London Hospital \"(UCLH\") is being contracted to undertake the Human work for this Trial. The Trial protocol and associated scientific information have been submitted to UCLH for consideration by their ethical and research committees, leading to their permission for ValiRx to use their facilities for the Human portion of the Trial.\n \nThe Trial, is to be conducted using prostate cancer patients and it is expected that the Trial will provide data on both its primary and secondary objectives, which are (i) to determine the maximum dose comparable with the safety and tolerability of VAL201; and (ii) to study the biochemical and physiological effects of VAL201 in relation to concentration and effect and make a preliminary assessment of anti-tumour activity. The intention is that the Trial should allow quick progress to a full efficacy or Phase II study.\nThe Board believes the protocol will deliver information on the safety profile of the compound and an indication of its efficacy in patients in as timely and economically efficient a manner as possible. The trial design is significantly more comprehensive and all encompassing than was originally conceived and submitted at the start of the clinical development phase and before to the Company's scientific meeting with the Medicines and Healthcare Products Regulatory Agency (\"MHRA\").\n \nThe supporting background scientific work has been completed and the required ancillary analyti...