PVG.L Regulatory News (PVG)

Continued Success of Ark's Manufacturing Partnership with PsiOxus Therapeutics

Initiation of Phase I Study for PsiOxus' ColoAd1 Oncolytic Product 

London, UK - 26 September 2012, Ark Therapeutics Group plc ("Ark") is pleased to announce that it has successfully completed the cGMP manufacture and release of drug product to PsiOxus Therapeutics Ltd ("PsiOxus") for use in a Phase 1 clinical trial of the oncolytic vaccine ColoAd1. Ark provided the material to PsiOxus under the partnership arrangement announced in September 2011.

The material was manufactured under stringent timelines at Ark's facility in Kuopio, Finland using Ark's proprietary suspension based single use process ("ATOSUS"). By using Ark's proprietary production platform, manufacture of toxicology material followed by clinical material of the required product quality was achieved within less than twelve months, saving significant time from the typical CMC development and manufacturing timelines.

ColoAd1 is a systemically available oncolytic vaccine under development by PsiOxus for the treatment of colorectal cancer. ColoAd1 has been shown capable of destroying tumour cells at minute concentrations in pre-clinical investigation.

John Beadle, CEO of PsiOxus, said: "Ark has demonstrated itself to be a value-added manufacturing partner with both the technical understanding and the manufacturing development capability and specific regulatory knowledge to enable us to hit our development timelines."

Dr David Venables, CEO of Ark commented: "We are delighted that our continued success in the manufacture of ColoAd1 will enable the development of this exciting product to progress on schedule, and we look forward to providing full support to PsiOxus as their programme advances through its clinical trial phases. This is further validation for Ark's ATOSUS process as an effective and reliable platform for adenoviral manufacture."

For further information please contact:

Ark Therapeutics Group plc

Ark Therapeutics Group plc is a leading viral product focused contract development and manufacturing services company with world-class viral research, development and GMP manufacturing operations in Finland and the UK. Ark's business model is to offer product development and GMP manufacturing contract services for viral products, including the areas of viral mediated gene therapy, oncolytic viral vaccines, live and attenuated viral vaccines, viral vectored vaccines and virus like particles. Ark's capabilities span from translational research through preclinical and clinical product development, in addition to process and analytical development, GMP manufacture and sterile filling from pre-clinical through to commercial product supply. These capabilities have been established through the development of Ark's own products through to Marketing Authorisation Application registered with the European Medicines Agency. Following a change in business strategy in 2011, Ark is now building its business through contract development and manufacturing services and is seeking external partners to advance those products it previously had under development. 

Ark's shares were first listed on the London Stock Exchange in March 2004 (AKT.L).

About PsiOxus Therapeutics Ltd

PsiOxus Therapeutics is an Oxford, UK-based development stage biotechnology company using non-traditional approaches to develop novel therapeutics that address cancer and other clinically unmet diseases. ColoAd1 is an oncolytic vaccine for the systemic treatment of metastatic cancer, which has demonstrated exceptional anti-cancer properties in late pre-clinical development and will begin clinical development later in 2012. MT-102 is a dual action Anabolic Catabolic Transforming Agent (ACTA) in phase II clinical development for the treatment of cachexia and sarcopenia. The Company is also developing treatments based upon the research phase vaccine platform PolySTAR, which combines recombinant viral vectors with polymers to shield them from the immune system, and the research phase adjuvant and immunotherapeutic platform PolyMAP, which combines polymers with synthetic adjuvants to significantly enhance the effectiveness of vaccines.

This announcement includes "forward-looking statements" which include all statements other than statements of historical facts, including, without limitation, those regarding the Group's financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to the Group's products and services), and any statements preceded by, followed by or that include forward-looking terminology such as the words "targets", "believes", "estimates", "expects", "aims", "intends", "will", "can", "may", "anticipates", "would", "should", "could" or similar expressions or the negative thereof. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors beyond the Group's control that could cause the actual results, performance or achievements of the Group to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Such forward-looking statements are based on numerous assumptions regarding the Group's present and future business strategies and the environment in which the Group will operate in the future. Among the important factors that could cause the Group's actual results, performance or achievements to differ materially from those in forward-looking statements include those relating to Ark's funding requirements, regulatory approvals, clinical trials, reliance on third parties, intellectual property, key personnel and other factors. These forward-looking statements speak only as at the date of this announcement. The Group expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained in this announcement to reflect any change in the Group's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, readers are cautioned not to rely on any forward-looking statement.