28th Jan 2010 07:02
First Refractory Angina Patient treated with VEGF-D shortform (EG011)
in Phase I/IIa trial
London, UK, 28 January 2010 - Ark Therapeutics Group plc ("Ark" or the "Company") announces today that the first patient has been enrolled and treated in the Phase I/IIa trial of adenoviral short-form Vascular Endothelial Growth Factor-D ("VEGF-D") in patients with refractory angina. The trial is being undertaken in collaboration with the AI Virtanen Institute in Kuopio, Finland. The programme (EG011) uses the angiogenic VEGF-D∆N∆C short-form gene (Ad-VEGF-D), in Ark's already successfully developed adenovirus platform.
The patient was given a single dose of 1 X 109 viral particles of Ad-VEGF-D and has been moved from post operative critical care recovery to the general ward. The NOGA catheter procedure to administer EG011 was uneventful and no adverse events of concern beyond those expected in the standard surgical procedure had been observed at the day 2 recovery point.
After a heart attack and successful recovery, an estimated 200,0001 patients per annum in the US and Europe, despite being given all existing treatments, are left with a relatively stable heart condition in which chest pain occurs after mild exertion or even when resting (refractory angina). This is because the heart muscle, usually around the area that has died during the heart attack, has insufficient blood supply to oxygenate the muscle properly (ischaemic myocardium). EG011 treatment is expected to increase the blood supply to these areas, thereby improving heart function and subsequent patient mobility.
The Phase I/IIa trial is an ascending dose controlled study in up to 30 chronic angina patients who have already been treated unsuccessfully with available licensed approaches, usually stents and balloon angioplasty. Patients will receive a single dose of either 1x109, 1x1010 or 1x1011 viral particles of Ad-VEGF-D, administered via the NOGA catheter system after NOGA mapping of the wall of the myocardium to locate the ischaemic areas. Controls will receive only NOGA mapping and patients will be blinded to the treatment groups. 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 Professor Juha Hartikainen and Doctor Marja Hedman of the Kuopio University Hospital. The study will assess the safety of EG011 as well as providing initial efficacy data.
EG011 was manufactured at Ark's cGMP facility in Kuopio, Finland.
Ark announced in June 2008 that, in its second pre-clinical therapeutic proof-of-principle study, EG011 had demonstrated an ability to grow new blood vessels and restore heart function following a heart attack (myocardial infarction). EG011 induced a four-fold increase in capillaries, which were haemodynamically functional at 21 days. The amount of blood pumped from the ventricle where the heart attack occurred was restored from 60% to 90% of the level before the heart attack, a highly significant (p=0.0002) result. A non active 'marker' gene (lacZ) in the same adenoviral vector was used as a control. EG011 appeared well tolerated with no differences in serious adverse events observed between active and control groups.
Dr David Eckland, Research and Development Director of Ark, commented: "The shortform VEGF- D gene continues to show increasing promise as an angiogenic treatment agent and we are very pleased to see the first refractory angina patient treated. Today's news of the product being successfully and uneventfully administered by NOGA catheter, directly to the ischaemic heart muscle where increased blood flow is needed, is a major step forward both technically and in advanced biomedicine."
Dr Nigel Parker Chief Executive Officer of Ark added: "First patient enrolment is a significant milestone. The progress we continue to make at Ark is facilitated by the use of our established adenoviral platform and a successful co-operation of academia and industry. EG011 is a very exiting 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 is growing in strength."
Refs.
1 Company estimates and various sources
-Ends-
For further information:
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Ark Therapeutics Group plc |
Tel: + 44 (0)20 7388 7722 |
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Dr Nigel Parker, CEO |
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Martyn Williams, CFO |
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Financial Dynamics |
Tel: +44 (0)20 7831 3113 |
|
Ben Atwell |
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Susan Quigley |
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 five marketed devices, Kerraboot®, Kerraped®, Flaminal®, Neuropad® and KerraMax® 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.
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