ValiRx Regulatory News (VAL)

15 May 2014

ValiRx Plc

("ValiRx" or "the Company")

ValiSeek Development Update

First Month of Operations after formation of Joint Venture

Show promising results on cancer indications progressing towards Phase II clinical studies

ValiRx Plc (AIM: VAL), the life science company with a focus on cancer diagnostics and therapeutics for personalised medicine, is pleased to provide a positive development and scientific update on the first month's progress at ValiSeek Limited ("ValiSeek"), ValiRx's joint venture company with Tangent Reprofiling Limited ("Tangent"). ValiSeek was formed to progress the novel cancer treatment VAL401 through its remaining preclinical development and towards clinical Phase II trials for the treatment of lung cancer and other oncology indications. 

VAL401 - Lung Cancer

The Company reports that key results from non-regulatory toxicology studies confirmed that the VAL401 formulation is well tolerated in our dosing schedule. These results therefore allow ValiSeek to plan future detailed regulatory toxicology and pharmacokinetic studies with greater confidence in securing a positive outcome for clinical studies.

Furthermore, the combination of components in the reformulation showed comparable results to prior data from the previous clinical usage of the drug permitting ValiSeek to better understand the regulatory route through to the clinic.

Further in vitro results have encouraged ValiSeek to investigate the precise subsets of patients suitable for clinical treatment with VAL401. Specifically, non-small cell lung cancer (adenocarcinoma, non-squamous) and small cell lung adenocarcinoma cell lines responded well to VAL401 treatment in vitro, expanding our previous results.

ValiSeek is now able to identify which cell lines to take forward into the next stage of studies and to make better informed clinical decisions on the selection of trial patients.

Broad spectrum use of VAL401 in cancer indications - prostate, pancreatic and breast cancers

Further to the lung cancer indication, new results have indicated potential utility in pancreatic cancer, with the cellular in vitro assay with pancreatic cancer cells responding in a comparable degree to the lung cancer cells. This complements earlier studies by Tangent, which also suggest utility in both prostate cancer and breast cancer, demonstrating the potential for broad spectrum use of VAL401 against solid adenocarcinoma tumours or cancers of hormone responsive glandular origin.

Dr Suzanne Dilly, CEO of ValiSeek Limited, commented: "We have seen a positive start to ValiSeek's work, with our initial plans of quickly identifying further opportunities, while simultaneously confirming that VAL401 presents no unexpected toxicology, coming to fruition. These results springboard VAL401 onto the efficacy testing and regulatory pathway, and I look forward to ValiSeek demonstrating further progress with its next batch of results later in the summer".

Dr Satu Vainikka remarked: "We are delighted that ValiSeek's first report confirms our expectations and hopes in the potential of VAL401 as both a lung cancer treatment and in its use as a platform for multiple additional cancers and it is a pleasing vindication of the companies coming together in our joint venture. ValiRx believes that this is a great opportunity to create significant benefit for the cancer patient and a corresponding increase in shareholder value."

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Notes for Editors

About ValiSeek

ValiSeek Limited ("ValiSeek") is a joint venture ("JV") company between ValiRx Plc and Tangent Reprofiling Limited, part of the SEEK Group. ValiSeek was formed to progress the drug VAL401 through its remaining preclinical development and towards Phase II trials for the treatment of lung cancer and other oncology indications

About SEEK

Founded in 2004, SEEK (previously known as PepTcell) is privately-owned and funded, with headquarters in London, UK. SEEK brings safe and low costs medicines to the patients as quickly as possible. It does this by modifying existing medicines to improve their efficacy within current label, dose and regime, by changing the indication but keeping the dose and dosing regime the same or by creating a new medicine when the previous options are unavailable.

Additional information about SEEK is available on the Company's website located at www.seekacure.com

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.