PVG.L Regulatory News (PVG)

First Peripheral Vascular Disease patient treated with high dose VEGF-D

in Phase I/IIa trial

London, UK, 19 April 2010 - Ark Therapeutics Group plc ("Ark" or the "Company") announces today that the first patient has been treated in the high dose Phase I/IIa trial of adenoviral Vascular Endothelial Growth Factor-D ("VEGF-D") in patients with peripheral vascular disease ("PVD"). The trial is being undertaken in collaboration with the AI Virtanen Institute in Kuopio, Finland. The programme (EG016) uses the angiogenic VEGF-D gene (Ad-VEGF-D) in Ark's already successfully developed adenovirus platform.

The patient was given 1 X 1011viral particles of Ad-VEGF-D into lower leg muscles one day before femoropopliteal artery bypass surgery to restore the main arterial blood flow to the lower leg.

An estimated 300,0001 patients per annum in the US and Europe, have sufficiently impaired blood flow to the lower limb due to atherosclerosis to require an operation to bypass the blocked blood vessel. Patients with impaired lower limb circulation suffer pain on using their legs (claudication) and in more severe cases, the leg tissue below the blocked artery dies and the leg has to be amputated.

The bypass operation connects a length of healthy blood vessel (taken from elsewhere in the patient's body, or in some cases a synthetic vessel) between the femoral artery which has good blood flow in the upper leg and the popliteal artery further down the leg to bypass the blocked area. The extent to which this operation is successful relies both on the extent to which the main arterial flow to the lower leg is restored by the bypass operation and the extent to which the patient can re-grow small blood vessels (capillaries) within the leg tissues to carry new blood supply to the areas which have had insufficient blood (ischaemic) for a period of time. Adenoviral mediated VEGF has already been shown by researchers in Finland to significantly increase new capillary growth in the ischaemic leg (AdVEGF-A, n = 54 patients, p2

The Phase I/IIa trial is a controlled study in patients with peripheral vascular disease who require femoropopliteal bypass surgery. Initially this programme will compare different doses of VEGF D longform prior to moving to VEGF D∆N∆C (shortform VEGF-D). Patients will receive either 1x109, 1x1011 viral particles of Ad-VEGF-D, administered by multiple injection into the muscle downstream of the bypass site 1-2 days before the bypass operation, allowing time for the gene to start to work prior to the bypass operation. This pre-bypass treatment approach should allow some advance restoration of the peripheral circulation improving the success of the bypass operation.

The study has been approved by the Finnish National Agency for Medicines (NAM) and is being conducted by Professor Ylä-Herttuala of the AI Virtanen Institute in Kuopio and Dr. Kimmo Mäkinen and Dr. Ismo Vajanto of the Kuopio University Hospital. The study will assess the safety of EG016 as well as providing initial efficacy data.

Prof John Martin Chief Scientific Officer at Ark, commented: "Having already demonstrated success in PVD patients in an earlier study with VEGF-A, we are very optimistic about the success of this trial and we believe our decisions to use VEGF-D and provide EG016 treatment prior to the bypass operation will enhance the overall benefits and success of both treatments to patients."

Dr Nigel Parker Chief Executive Officer of Ark added: "This enrolment is an important milestone. The progress we continue to make at Ark is facilitated by the use of our established adenoviral platform and a successful co-operation between academia and industry. EG016 is a very exciting product opportunity in a large market with significant unmet clinical need and we look forward to announcing further trial progress as well as news on our other VEGF-D clinical candidates as the year progresses. Our angiogenic gene-based portfolio continues to grow in strength."

Refs.

1 Company estimates and various sources

2 Increased Vascularity Detected by Digital Subtraction Angiography after VEGF Gene Transfer to Human Lower Limb Artery: A Randomized, Placebo-Controlled, Double-Blinded Phase II Study. Kimmo Mäkinen, Hannu Manninen,Marja Hedman,Pekka Matsi,Hanna Mussalo,Esko Alhava and Seppo Ylä-Herttuala. Mol Ther 2002:6:127-133

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Notes to Editors

Ark Therapeutics Group plc

Ark Therapeutics Group plc is a specialist healthcare group (the "Group") addressing high value areas of unmet medical need within vascular disease, wound care and cancer. These are large and growing markets, where opportunities exist for effective new products to generate significant revenues. With six marketed devices, Kerraboot®, Kerraped®, Flaminal®, Neuropad®, KerraMax® and Kerraglove®and three further lead pharmaceutical products in late stage clinical development: Cerepro®, Vitor™, and Trinam®, the Group is transitioning from an R&D company to a commercial, revenue generating business.

Ark's own products are sourced from related but largely non-dependent technologies within the Group and have been selected both to enable them to be taken through development within the Group's own means and to benefit from Orphan Drug Status and/or Fast Track Designation, where appropriate. This strategy has allowed the Group to retain greater value and greater control of clinical development timelines, and to mitigate the risks of dependency on any one particular programme or development partner. Ark has secured patents or has patent applications pending for all its lead products in principal pharmaceutical markets.

Ark has its origins in businesses established in the mid-1990s by Professor John Martin and Mr Stephen Barker of University College London and Professor Seppo Ylä-Herttuala of the AI Virtanen Institute at the University of Kuopio, Finland, all of whom play leading roles in the Company's research and development programmes.

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.