Business
Re: VAL201 - Update
Re: VAL201 - Update.
About this update from Valirx Plc
[{"type":"text","content":"\n \nRNS Number : 3571R ValiRx PLC 24 October 2013 \n\n \n \n24 October 2013\n \nValiRx Plc\n(\"ValiRx\" or the \"Company\")\nRe: VAL201 - Update \nValiRx Plc (AIM: VAL), a life science company with a focus on cancer therapeutics for personalised medicine, is pleased to report that the Clinical Trial Project Team (\"Project Team\") which comprises independent experts in the various disciplines covering all aspects of the study for VAL201, ValiRx's leading anti-cancer therapeutic, has signed off on the protocol for its enhanced Phase 1b trial which is expected to advance to a Phase 2 study. \nThe additional information required for the expanded Final Trial Management documentation, including the Investigational Brochure, the Investigational Medicinal Product Dossier and Clinical Trial Application for the new trial, are now being completed so that all remaining permissions and approvals are obtained for this trial to commence in Q1 2014. The expanded trial is anticipated to yield early results within 8 weeks of commencement. \nOriginally, and as previously announced, a First in Human Phase 1 trial to merely demonstrate safety had been contemplated. However, during the clinical development process the original study concept has been expanded into a significantly more comprehensive Phase 1b trial, which, in addition to establishing the safety of VAL201, the trial will now also provide an initial measure of VAL201's efficacy in the treatment of patients with prostate cancer as well as patients with other solid tumors. This more comprehensive trial will now supersede the original trial concept. These changes follow advice and recommendations from the Company, its advisors and independent experts as well as the Medicines and Healthcare Products Regulatory Agency and from University College London Hospital, the clinical trial centre. \nAlthough the scope of the trial has been expanded, the Company has sufficient funds to fulfill the aim of the original First-in-Man Phase 1 trial announced last year, which focused exclusively on demonstrating safety, and now represents only a part of the expanded trial. \nWhile the results of this trial will come later than the projected timeline for the original First in Human Phase 1 trial, we anticipate that the revised strategy will accelerate VAL201's clinical programme to Phase...