ValiRx Regulatory News (VAL)

22 Dec 2009 12:19



ValiRx PLC (AIM: VAL)

("ValiRx" or the "Company")

Regional Funding

Company secures further development funding to progress key diagnostics development to clinical validation

ValiRx Plc (AIM: VAL) is pleased to announce that it has secured a grant of €1.05 million from the Walloon Region of Belgium to fund ValiBio, a subsidiary of ValiRx, based in Gosselies, Belgium. 

The grant is to support the development by ValiBio of screening tests for early stage cancer diagnosis derived from ValiBio's NucleosomicsTM technology. These new diagnostic tools for the detection of colorectal cancers are expected to enter clinical validation during 2010. Additionally, the grant is to further the technological development of ValiBio's other cancer screening technologies. This project will be implemented with the support of regional academic and industrial partners for the rapid commercialisation of the first products. The tools that are being developed can be used for other cancers as well and ValiBio has entered into a collaboration with one of the biggest molecular biology organisations in Europe in order to develop the test for lung cancer. ValiBio is also in discussions for collaborations in other cancer fields.

The project is planned as a two year programme with an initial budget of €1.7 million, 60% of which is being covered by the grant. The programme was started by ValiBio in April 2009. The grant will be made available in several tranches including an initial payment covering allowable costs already incurred by ValiBio since the start of the project. The clinical validation programme which will start in 2010 will initially involve a pilot study of 100 patients followed by a multicentre study in 3 to 4 countries with up to 400 patients.

The grant is repayable only if a commercially successful product is developed. If so, it will be repaid in annual minimum amounts over 5 years starting in 2012, covering up to 30% of the funding, and the remaining amount by a royalty of 6% on net sales over a maximum of 10 years starting after 2012. The grant will not be repayable if a product is not successfully developed.

Nucleosomics is a novel technology with potential for early stage cancer detection. The Company has previously reported promising preliminary results in the detection of histone modifications in blood samples which may be indicative of the presence of cancer. Cancer is one of the biggest killers in the developed world and early diagnosis improves prognosis and patient survival. There is significant demand from the medical community for accurate early stage diagnostic technologies. The target market size for in vitro cancer diagnostics is currently estimated at €7.5b.

Update

The Company's general meeting is still scheduled for 10am on 30 December, 2009. The resolutions, if approved by shareholders, will provide the Company with share authorities should the Company look to pursue a further equity funding. However, it is not anticipated that these authorities will be utilised at the current time and the Company continues to pursue all funding options, including securing grants such as that received by ValiBio.

Dr Satu Vainikka, CEO of ValiRx, commented:

"We are very pleased to announce the support of the Walloon region. This grant reinforces the potential value of our technology platform and the ensuing cancer diagnostics for the early detection of this disease to improve therapeutic outcome. The market launch of these products will support the complementary cancer therapeutic development activities of ValiRx." 

Enquiries

ValiRx - www.valirx.com 

ValiRx plc (AIM:VAL, 'ValiRx') is a cancer therapeutics and diagnostics company headquartered in London, England and admitted to AIM in October 2006. The Company operates through two subsidiaries, ValiPharma (formerly trading as Cronos Therapeutics) (www.valipharma.com), a UK-based epigenetic drug discovery and development business and ValiBio SA (www.valibio.com), its Belgium-based oncology diagnostics operation.

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ValiBio SA  www.valiBio.com

ValiBio has two epigenetic diagnostic platforms - Nucleosomics™, and HyperGenomics™ which it licensed from ValiRx. 

NucleosomicsTM is a platform for non-invasive (blood) tests for early cancer diagnosis based on epigenetic signal changes associated with malignancy. ELISA tests for global histone modifications expressed in cell free nucleosomes in blood that are characteristic of cancers are currently under development. The company expects to launch early Nucleosomics products for research use in 2009. Diagnostic products regulated by European rules (CE marking) and the FDA will follow. Early disease focus is in lung, pancreatic and colon cancer. 

HyperGenomicsTM is a platform for differential epigenetic diagnostic and prognostic tests in cancer as well as testing for personalised medicine. The platform performs rapid, genome wide detection and identification of hypersensitive sites in cells and ValiBio is developing differential diagnostic products for colorectal cancers.