ValiRx Regulatory News (VAL)

12 Mar 2009 07:00



ValiRx plc

ValiRx Announces Promising In Vivo Data for Therapeutic Cancer Compound VAL 101, Based on its Gene Silencing GeneICE™ Technology Platform

12 March 2009, London: ValiRx plc (AIM:VAL, "ValiRx" or the "Company"), the cancer therapeutics and diagnostics company, announced today the successful completion of its first collaborative stage with Cancer Research Technology ("CRT"), undertaken through ValiRx's biopharmaceutical division ValiPharma. Trials completed under the collaborative agreement have shown positive in vivo results for ValiPharma's therapeutic cancer compound, VAL 101. The Company continues with its plans to progress VAL 101 towards Phase I filing. 

Data from the studies indicated tumor growth reduction was dose dependent with no unexpected side effects, indicating VAL 101 to be well tolerated within the effective dose range. The study also identified a potential suitable delivery system for the compound. ValiRx has now obtained completed in vivo results from CRT and, based on these successful results, ValiRx will progress to late stage in vivo preclinical studies for VAL 101.

ValiRx's therapeutic cancer compound VAL 101 is based on the Company's proprietary gene silencing technology, GeneICETM. Previous results have shown VAL 101's efficacy in several cell-based cancer models, including prostate, ovarian and pancreatic cancers in vitro. In vivo results to date have demonstrated and validated VAL 101's efficiency as a novel cancer therapeutic in reducing pancreatic cancer tumour growth in an animal model after single administration.

ValiRx's GeneICETM technology platform utilises inherent cell gene control mechanisms to trigger and/or assist cancer cell death. ValiRx uses GeneICETM to target and silence genes involved in cancer development and other diseases including neurological conditions.

The Company is also continuing with the development of its second compound, VAL 201, an anti-cancer molecule targeting hormone refractory cancers, with CRT. VAL 201 inhibits androgen, estrogen and epithelial growth factor dependent DNA synthesis, and has shown efficacy in pre-clinical studies against prostate and breast cancer. 

Commenting on these results, CEO of ValiRx Dr. Satu Vainikka said: "ValiRx is pleased to announce the continued development of our first GeneICETM cancer therapeutic, VAL 101. These in vivo results provide positive and evidentiary support for the use of our GeneICETM technology platform as a cancer therapeutic, proving our technology platform can be translated into real tumour growth inhibition. GeneICETM holds promise for application in a wide variety of disease areas."

The overall bio-therapeutics market is currently valued in excess of $87Bn and is the fastest growing pharma sector, estimated to account for 60% of big pharma revenue growth by 2010. 

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Notes to Editors 

About 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), a Belgium-based oncology diagnostics operation.

Therapeutics -- ValiPharma

ValiRx utilises a cells own inherent gene control machinery to silence genes involved in cancer cell progression, effectively "switching off" genes involved in certain forms of cancer through its platform technology GeneICE™ (Gene Inactivation by Chromatin Engineering),. GeneICE™ works through the recruitment of silencing complexes known as Histone Deacetylase Complexes (HDACs) to target genes involved in cancer. ValiRx's lead product VAL 101 targets the anti-apoptotic gene BCL-2 which is over expressed in many cancers including in pancreatic cancer. The Company has also recently expanded its pre-clinical portfolio to include VAL 201 in prostate cancer.

Gene silencing technology platform potentially represents an innovative and ground breaking new approach to cancer treatment as it allows for the development of targeted, personalised medicine and treatment for patients. GeneICE™ is also applicable to a wide variety of other genetic disorders such as in the fields of neurology and inflammatory diseases.

Diagnostics - ValiBIO

ValiRx currently has two epigenetic diagnosis products - HyperGenomics™, a method for the detection and identification of hypersensitive sites in cells and Nucleosomics™, a non-invasive (blood) test for early cancer diagnosis based on epigenetic signal changes associated with malignancy - which it licences to its subsidiary, ValiBIO.

In December 2008, ValiBIO entered into an exclusive worldwide distribution agreement with international medical devices company Biofield Corp for its Human Papilloma Virus (HPV) diagnostic test for cervical cancer and a worldwide distribution agreement (excluding Belgium) for its Hypergenomics™ and Nucleosomics™ diagnostics products. ValiRx also sold a 10% stake in ValiBIO for €600,000 in cash to Biofield, with an option for Biofield to purchase an additional 15% of the Belgium-based operation. 

NucleosomicsTM diagnostic productsNucleosomicsTM 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 EMEA and the FDA will follow. Early disease focus is in lung, pancreatic and colon cancer.

HyperGenomicsTM diagnostic productsHyperGenomicsTM is a platform for differential diagnostic and prognostic tests in cancer as well as testing for personalised medicine. ValiBIO is developing differential diagnostic products for cancer. The company's early disease focus is in leukaemia, prostate and colon cancer.