24 October 2013
ValiRx Plc
("ValiRx" or the "Company")
Re: VAL201 - Update
ValiRx 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.
The 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.
Originally, 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.
Although 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.
While 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 2a and 2b studies, which are key value inflection points, and lead to time and cost savings alongside generating greater value.
Dr Satu Vainikka, Chief Executive, commented: "With the support of members of the Clinical Trial Project Team, in particular the Principal Investigators, we have arrived at a trial protocol that will provide considerably more clinical data on VAL201 than originally planned. Our expectation is that demonstrating VAL201's safety and obtaining a measure of its efficacy in the same study will not only hasten the drug's clinical development but will also raise shareholder value. The extra information provided by this study will moreover make the product more attractive to potential partners"
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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:
ValiFinn is the biomarkers and diagnostic development division
ValiPharma is the therapeutics division with two embedded technologies primarily directed at the treatment of cancers.
