ValiRx Regulatory News (VAL)

2 September 2014

ValiRx Plc

("ValiRx" or "the Company")

ValiSeek Development Update

Successful completion of preclinical efficacy studies in non-small cell lung cancer

ValiRx Plc (AIM: VAL), the life science company with a focus on cancer diagnostics and therapeutics for personalised medicine, is pleased to provide a further development and scientific update on the progress of pre-clinical studies at ValiSeek Limited ("ValiSeek"), ValiRx's joint venture company with Tangent Reprofiling Limited ("Tangent").

ValiSeek was formed to develop VAL401, the novel lung cancer treatment drug, through its remaining preclinical development and towards Clinical Efficacy (Phase II) trials for the treatment of lung cancer and potentially other oncology indications. 

Further to our development update on 15 May 2014, ValiSeek now reports on the completion of the efficacy phase of pre-clinical testing for the use of VAL401 in non-small cell lung cancer.  Studies demonstrated a mean response with at least a 50 per cent. reduction in the rate of tumour growth in an accepted standard cancer model.

Furthermore, no adverse effects were seen during the course of the experiment, which comprised six weeks of continuous treatment at three differing dose levels. The Company believes that these positive and exciting results confirm the promise shown by the earlier reported cellular assay results.

These in vivo study results will form the foundation of a submission for scientific advice to the MHRA for its review of the planned clinical development programme for VAL401. The formulation and preliminary pre-clinical toxicology results are expected be collated and reported by the end of 2014.

Further efficacy studies will be carried out in due course to establish the potential utility of VAL401 and its broad spectrum use against solid adenocarcinoma tumours or cancers of hormone responsive glandular origin, which include prostate, breast and pancreatic cancers and other small cell lung cancers.

Dr Suzanne Dilly, CEO of ValiSeek, commented: "With the science progressing on schedule, I am delighted to be able to report the successful completion of our non-small cell lung cancer preclinical efficacy studies. These results allow us to plan our course through the regulatory pathways into a full clinical study."

Dr Satu Vainikka, CEO of ValiRx plc, added: "The ValiSeek pre-clinical efficacy results are highly encouraging and progress VAL401 further down its remaining pre-clinical development pipeline. This adds commercial value and further enhances ValiRx's portfolio of treatments for multiple cancer indications. I look forward to VAL401's continued future enhancement and progress through clinical trials."

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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.

3. ValiSeek is a joint venture with Tangent Reprofiling Limited to progress the novel lung cancer treatment drug, VAL401, through its remaining preclinical development and towards Clinical Efficacy (Phase II) trials for the treatment of lung cancer and potentially other oncology indications.