3 October 2013
ValiRx Plc
("ValiRx" or the "Company")
Re: VAL201 - Filing of Phase IB Clinical Trial to be undertaken at
University College London Hospital "(UCLH")
ValiRx 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.
The 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.
The 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.
The 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").
The supporting background scientific work has been completed and the required ancillary analytical methods and procedures have now been established and are in place to complete the Human portion of the Trial.
Dr Satu Vainikka, Chief Executive, commented: "I am delighted with the progress of our compound and with all the hard work from the team to get VAL201 into first-in-man trials. I look forward to its further progress and development and to the compound's future potential as a life-saving treatment against a number of cancers".
The study Protocol is entitled:
A Phase 1b, Dose Escalation Study to Assess the Safety and Tolerability of VAL201 in Patients with Locally Advanced or Metastatic Prostate Cancer and Other Advanced Solid Tumours.
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For more information, please contact:
ValiRx plc |
Tel: +44 (0) 20 3008 4416 |
Dr Satu Vainikka |
www.ValiRx.com |
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Cairn Financial Advisers LLP (Nominated Adviser) |
Tel:+44 (0) 20 7148 7900 |
Liam Murray / Avi Robinson |
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Hybridan LLP (Broker) |
Tel: +44 (0) 20 7947 4350 / 4361 |
Claire Louise Noyce / William Lynne |
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Peckwater PR |
Tel: +44 (0)7879 458 364 |
Tarquin Edwards |
[email protected] |
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Notes for Editors
ValiRx Plc
ValiRx Plc is a biopharmaceutical company developing novel technologies and products in oncology therapeutics and diagnostics. The product focus is in the epigenomic analysis and treatment of cancer, but the technologies can be applied to other fields as well, such as neurology and inflammatory diseases.
The Company listed on AIM in October 2006 and is creating a portfolio of innovative products through investment in specific development projects. It actively manages projects within this portfolio as a trading company and is not an investment vehicle. The ValiRx business model spreads the risks of life science technology developments by minimising financial exposure and running a set of projects to defined commercial endpoints. This maximises returns to shareholders by adding value at the earlier stages where value increases per investment unit are the greatest.
The Company operates through the following divisional companies:
1. ValiFinn is the biomarkers and diagnostic development division
2. ValiPharma is the therapeutics division with two embedded technologies primarily directed at the treatment of cancers.
