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.”
Read more: http://www.pharmiweb.com/pressreleases/pressrel.asp?ROW_ID=14786#ixzz0ePd8hPcd
