PVG.L Regulatory News (PVG)

ARK THERAPEUTICS GROUP PLC

Completion of the dose ranging Phase I section of refractory angina clinical study

Enrolment into Phase IIa stage expected to begin Q3 2012

London, UK, 16 May 2012 - Ark Therapeutics Group plc (AKT: LSE) ("Ark" or "the Company") is pleased to announce completion of the dose ranging Phase I section of the academic study of Ark's VEGF-D adenoviral vector treatment for refractory angina. The study is being carried out in collaboration with the AIV Institute in Finland. The subsequent Phase IIa controlled efficacy stage will comprise 15 additional patients to be treated with the optimal dose identified from Phase I and will also compare with controls for indicators of both safety and efficacy. The Phase IIa stage is expected to enrol its first patient in Q3 2012.

Refractory angina is a consequence of insufficient blood supply to the areas of heart muscle damaged by a heart attack. Ark's adenoviral vector carrying a transgene for expression of pro-angiogenic human VEGF-D is designed to treat the condition by stimulating new blood vessel generation at the ischemic heart muscle to which it is directly administered. 

Professor Ylä-Herttuala, Consultant Director of Molecular Medicine at Ark commented:

"This is an important step in the development of this new local therapy for severe refractory angina and coronary heart disease patients. Ark's gene drug delivery is accomplished with a precision catheter system directly into myocardium thus lowering the required dose and targeting the vector directly to the ischemic area where it is needed."

Martyn Williams, Chief Executive of Ark commented:

"This important milestone is further evidence of progress in our portfolio of gene-based therapeutics using our established adenoviral delivery system to treat hitherto intractable conditions."

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Ark Therapeutics Group plc

Ark Therapeutics Group plc is an innovative gene-based medicine company with operations in the UK and Finland that seeks to capitalise through partnerships on its pipeline of programmes in high value areas of unmet medical need within vascular disease and cancer, and to exploit its unrivalled viral manufacturing capability based in Kuopio, Finland. Ark Therapeutics' biological manufacturing operations provide process development and manufacturing for a growing number of third party clients for a variety of stages of therapeutic development, as well as for its own internal programmes.

Ark's research is focused on discovering new approaches to gene delivery using viral vectors with particular emphasis on genes that control tissue vascularisation, especially VEGF, and is based on the work of its two world-leading research centres in Kuopio and London. The Finnish group is led by Professor Seppo Ylä-Herttuala and is expert in the exploitation of viral technology to address serious medical problems, while Professor John Martin leads a team in London who have complementary skills in the understanding of biological structures and the development of small molecule agonists and antagonists. This combination of skills has resulted in Ark identifying and bringing forward a number of attractive programmes in gene therapeutics and small molecules

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

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.