Beursonline.nl

flosz 11 maart 2009 09:31

4

Trinam®
We continued to work closely with the US regulators to progress the SPA process through the first half of the year and this was formally awarded in June 2008. Concurrently, the Investigative New Drug ("IND") application reviewer requested that one of the battery of batch release assays be 'qualified' with further data. Work on qualification commenced immediately as did work with US investigator sites to enable enrolment of the first patient into the trial as soon as clearance of the assay was received.
A suitable assay was qualified late in the period in line with the revised draft guideline covering this area issued by the FDA in October. Post-period we have filed the requisite IND updates with the FDA and recruitment of the first patient is expected shortly.

SUMMARY AND OUTLOOK

In 2008 we continued to make solid progress in pioneering and building our specialist gene-based medicine products and capabilities. Not only have the Phase III leads moved successfully through key late-stage regulatory milestones, but we have strengthened the underlying pre-clinical pipeline to be in a position to take three more gene-based products into the Phase I/IIa trial stage in 2009. Our UK wound care sales are showing increasing strength and whilst sales are still relatively small we are optimistic for the growth of the wound care business towards break-even in 2009. Our manufacturing capabilities have been successfully expanded and we are now self-sufficient for our own needs and rapidly becoming recognised as the 'state-of-the-art' European site for production and fill of viral gene-based medicines and comparable advanced biologics. The new facility has already prompted a number of enquiries for third party manufacture.

During 2009 we expect to give the first annual update of the Cerepro® Phase III results, the read-out of the results for the VitorTM Phase III pilot study and to report on the progress of recruitment for the Phase III trial for Trinam®. As the year progresses we will report the outcome of the Cerepro® MAA and on our plans for commercialising the product in Europe and non-core territories. We also look forward to reporting on our activities to realise the value of our stroke patent. Finally, we expect to give periodic updates on progress of short-form VEGF-D based programmes in the Phase I/IIa trial stage.

We entered 2009 with cash and money market investments of £40.6m and in a period of global financial uncertainty, the Company will maintain its focus on managing its resources and cost base carefully and proactively to ensure that it can continue to meet its key value-generating objectives.

In summary we will continue to build and strengthen our position in the DNA-based medicine area and increase our commercial effectiveness to develop Ark into a sustainable advanced biomedicines provider.

Research and development expenses
Ark conducts research at its facilities in Kuopio, Finland, at University College London and through a specialist chemistry sub-contractor. Clinical studies are carried out by approved clinical research organisations within Europe and North America under the close supervision of senior project managers employed by the Group. Research and development expenditure in 2008 was £16.5m (2007: £14.6m), the increase reflecting additional expenditure on selected pre-clinical programmes and on manufacturing scale-up and support for Cerepro® and Trinam®. Research and development expenses comprise clinical development costs, manufacturing development costs and research costs and are detailed below.

Clinical development costs
Major expenditures during the year were to complete the Phase III study for Cerepro® and to prepare the Marketing Approval Authorisation Application (MAA) for submission to the EMEA, the commencement of recruitment into the Vitor™ Phase III pilot study and preparatory activities for the Trinam® Phase III study. It is anticipated that 2009 will see the completion of the Vitor™ Phase III pilot study, the commencement of recruitment into the Trinam® Phase III study and further expenditure on the late-stage pre-clinical programmes, including initial clinical work.

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flosz 7 april 2009 13:47

2

RNS Number : 2493Q
Ark Therapeutics Group PLC
07 April 2009

Cerepro® Phase III trial update

-Analyses strengthen as more patients reach endpoint-

London, UK, 7 April, 2009 - Ark Therapeutics Group plc (AKT:LSE) ("Ark" or "the Company") is pleased to announce that it has completed the first update of the results of its Cerepro® Phase III trial (Study 904) in accordance with reporting regulations. Cerepro®, Ark's novel gene-based medicine, is being developed as an Orphan Drug for the treatment of operable malignant glioma. The update showed the main results strengthening in Cerepro's® favour.

Study 904 was a multicentre, standard care controlled, pivotal trial in 236 patients. The study was designed to confirm the safety and efficacy of Cerepro® in patients with operable high grade glioma (brain cancer) against current standard care treatment options. Standard care was surgery and radiotherapy or surgery and radiotherapy followed approximately 40 days post-operatively by temozolomide, depending on the investigating centres' standard practice and patient suitability. Patients were randomised to either standard care plus Cerepro® (one administration by multiple injection into the healthy brain at the end of the tumour resection procedure) or standard care alone. The primary endpoint was survival, defined as time to death or re-intervention(1). At randomisation, the treatment groups were well matched in terms of demographics and the standard prognostic features (age, Karnofsky Score etc).

Results of the Phase III trial were first reported on 30 July 2008 when 53 patients had yet to reach a primary endpoint. In the latest update analysis, median survival and adverse event profile results are consistent with those previously reported. On the primary endpoint of death or re-intervention, Kaplan Meier curves have improved to show a clear sustained separation from around 4 months post surgery in favour of Cerepro® treatment. Significance levels associated with the main data have improved in the update analyses. Twenty nine patients have still to reach a primary endpoint event (versus 53 previously), of which 18 have been treated with Cerepro® and 11 received standard care.

In relation to secondary endpoints, Magnetic Resonance Image (MRI) assessment of the progression free survival time, accounting for pseudo-progression, are supportive of the primary endpoint results. The effect of Cerepro® on overall survival (all cause mortality) is, as expected, complicated by the number of crossover therapies used after reintervention. Data do however show increasing support for improved overall survival in patients receiving Cerepro® after about 500 days with 56 patients in the trial still alive.

A marketing approval application (MAA) for Cerepro® was filed with EMEA in Q4 2008 and regulatory review commenced early this year. An opinion from the CHMP is expected in Q4 of this year.

(1) Re-intervention is defined as any kind of treatment (surgery, chemotherapy or radiotherapy) given to prolong survival after tumour recurrence.

Dr. Nigel Parker, Chief Executive of Ark commented: 'We are pleased with the latest update of the study. The pattern we are seeing appears to be closely tracking our experiences with the previous Phase II studies where results strengthened in favour of Cerepro® treatment as the data on the longer surviving patients becomes available. The update will be provided to the regulators in accordance with standard process. Overall, our adenoviral platform and portfolio is making consistent progress and we look forward to providing the market with further updates on the portfolio in due course.''
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harvester 8 april 2009 06:44

0

ARK koers gisteren omhoog 46.75 p Change: + 4.75p
Last Trade: 7/4/2009 19:36

harvester 8 april 2009 21:42

0

koers weer omhoog vandaag van ARK

quote:
harvester schreef:
ARK koers gisteren omhoog 46.75 p Change: + 4.75p
Last Trade: 7/4/2009 19:36

49.25 p
Change: 2.50p
Last Trade: 8/4/2009 20:22
View share price data

flosz 17 april 2009 12:25

7

From The Times
April 14, 2009
Hope for women whose babies stop growing in womb
Pregnant women who face losing their unborn babies to a so-far incurable growth disorder are to be offered a pioneering gene therapy that could treat the condition in the womb, The Times has learnt.
The world’s first patient study of a gene-based drug designed for use in pregnancy could begin this year, after groundbreaking research by British scientists.
The treatment could offer hope to thousands of couples who lose their babies to stillbirth, miscarriage and enforced abortions because they stop growing in the womb.
The condition, known as severe foetal growth restriction (SFGR), occurs because of reduced blood flow to the placenta, and affects about 1 in 500 pregnancies, or more than 1,000 in Britain each year.
Doctors can attempt to prevent it but only when women know they are susceptible because they have lost a pregnancy before. Less serious forms affect one pregnancy in twenty, and can lead to prematurity, lifelong illness and learning difficulties.
The therapy, developed by researchers at University College London Hospitals and Ark Therapeutics, a biotechnology company, uses a genetically engineered virus to deliver extra copies of a gene that promotes blood flow to the mother’s uterine arteries.
The goal is to ensure that more blood reaches the placenta and the foetus, so it gets the nutrients it requires to start growing again and survives.
Experiments with pregnant sheep have had encouraging results, showing that the drug significantly increases blood flow to the placenta. The research team is conducting fresh studies with guinea pigs and expects to start patient trials at the end of this year or early in 2010.
Regulators have already indicated that an initial safety study should be cleared quickly. The viral vector that conveys the gene therapy is already approved for human use and, as the disorder has such a poor prognosis, the research does not raise serious issues about risk to the foetus.
Anna David, Senior Lecturer in Obstetrics and Maternal and Foetal Medicine at University College London Hospitals and the lead researcher, said that SGFR was among the most intractable and distressing conditions that affects pregnancy. “The mother seems fit and healthy, and the foetus has no chromosomal problems or structural abnormalities, like a heart defect, yet it stops growing around the mid-point of pregnancy,” she said.
“Once it’s detected, there is nothing very much you can do about it. At the moment the only options we can offer parents are to terminate the pregnancy, or to continue in the hope that the baby gets to 600g or 27 weeks, in which case it might just have a chance. But most babies don’t get that far and die.”
The drug was expected to improve blood flow only for a few weeks, but this could make all the difference, Dr David said. “At this stage of gestation, survival goes up by 2 per cent a day. A week of growth can improve survival by 15 per cent. When we’re talking about a baby that has only a small chance, that’s huge.”
She said that women who have experienced SFGR before can be given aspirin in subsequent pregnancies to improve blood flow. This must be done before 16 weeks, however, and it is not possible when a woman does not know she is at risk.
The patient study will be a new departure for gene therapy, which uses viruses to ferry new copies of genes into cells to improve their function, as it is the first such treatment targeted at pregnant women.
Gene therapy has already been used successfully against several serious conditions, including childhood immune deficiencies that are fatal if untreated, and a cause of blindness called Leber’s congenital amaurosis. Despite its promise, however, it is controversial because the viral vectors that are required have sometimes had fatal side-effects. The gene delivery system that is being used in the SFGR treatment is much safer than some methods. The vector is an adenovirus like the one that causes the common cold, which is not considered dangerous, and it is already being used safely in Cerepro, a drug developed by Ark Therapeutics to treat brain cancer.
The virus is engineered to carry a gene called VEGF-D, which is involved in blood vessel growth and blood flow, to the uterine arteries that supply the placenta with blood.
Nigel Parker, chief executive of Ark Therapeutics, said: “It’s a vector system that has already been through regulatory review. We think we’re getting close to the natural molecular biology of pregnancy and tuning it up, getting the blood vessels to expand and take more blood through to the placenta.
“This is a gene that is naturally there in the mother and the baby. It’s a virus that all pregnant women already get: the common cold virus. I can see a whole gene therapy world opening up.”
Dr David said that it remains important to complete animal studies to show that the drug is unlikely to be toxic to mothers, and that it does not appear to cross the placenta. The guinea pig experiments, which are funded by Action Research, should achieve this by the end of the year.
The initial clinical study will investigate whether the gene therapy is safe. If it succeeds, Dr David plans to conduct a larger trial to evaluate the effectiveness of the drug.
Janet Scott, of Sands, the stillbirth and neonatal death charity, said: “Foetal growth restriction is a very ignored area . . . It is very welcome that these scientists are paying attention to this problem: an in-utero treatment that improves growth would be a big advance
women.timesonline.co.uk/tol/life_and_...

flosz 17 april 2009 12:49

5

quote:
flosz schreef:
Severe foetal growth restriction (SFGR)

Trinam® Variantjes......

Trinam® Variant
(EG011) ->Refractory angina

Trinam® Variant
(EG012) ->Foetal growth restriction

Trinam® Variant
(EG013) -> CABG & angioplasty

Trinam® Variant
(EG014) ->Wound healing

P.21.
investors.arktherapeutics.com/ppt/Pre...

flosz 23 april 2009 09:15

3

quote:
flosz schreef:
Trinam® Variant
(EG011) ->Refractory angina

Trinam® Variant
(EG012) ->Foetal growth restriction

Trinam® Variant
(EG013) -> CABG & angioplasty

Trinam® Variant
(EG014) ->Wound healing

P.21.
investors.arktherapeutics.com/ppt/Pre...

Mmm, dit klopt niet helemaal imo.
EG012
P.4
investors.arktherapeutics.com/pdf/Pre...

EG013 is a TrinamÂ® variant VEGF based gene medicine under development for fetal growth restriction, an often terminal condition where insufficient blood supply via the placenta results in serious growth retardation, leading to premature
death or undesired termination of a baby in an otherwise healthy mother or long term neurological problems in surviving infants. The problem is usually first diagnosed about 20 weeks into pregnancy and at present there is no effective treatment.

Results from the first trial in a preclinical model of blood flow to the placenta have shown that a single treatment with EG013, given directly into the mother's uterine artery, increased blood flow to the placenta by 25%, an improvement that is
believed adequate to treat the condition. The latest results of the second set of experiments have shown that the significantly increased blood flow after treatment with EG013 is maintained out to 50 days. If confirmed in human studies, a therapy with
this magnitude and duration of effect could allow the fetus to grow satisfactorily to a stage where caesarean delivery of a healthy baby could be reliably performed. Preliminary biodistribution results using immunohistochemical techniques have indicated
that there is no transfer of the gene into the fetus
**************************

Results of Annual General Meeting
London, UK, 22 April 2009: At the Annual General Meeting of Ark Therapeutics Group plc (LSE: AKT) held today all resolutions were passed. A summary of the proxy voting will be published in the Investor Relations section of the Company's website at www.arktherapeutics.com

flosz 1 mei 2009 12:58

0

RNS Number : 4808R
Ark Therapeutics Group PLC
30 April 2009

Prestigious European R&D prize won by Ark founder

2009 InBev-Baillet Latour Health Prize awarded to Professor Seppo Ylä-Herttuala

London, UK, 30 April 2009 - Ark Therapeutics Group plc (AKT:LSE) ("Ark" or "the Company") is pleased to announce that Professor Seppo Ylä-Herttuala, Consultant Director of Molecular Medicine at Ark, has been awarded the prestigious 2009 InBev-Baillet Latour Health Prize together with Professor Kari Alitalo of Helsinki University. The Prize, which is presented in Belgium, is awarded to scientists for outstanding contribution to biomedical research and the benefits that their research has to human health.

The 2009 Health Prize, which focused on Cardiovascular Diseases, was awarded to Professors Ylä-Herttuala and Alitalo for their groundbreaking work in relation to the Vascular Endothelial Growth Factor (VEGF) family of genes. Their research has pioneered the delivery of VEGF genes in adenovirus to the vascular system and encompasses discovery, gene cloning, manufacturing and pre-clinical studies and more recently, clinical studies in coronary heart disease and peripheral vascular disease. The majority of their research has been done at the Universities of Kuopio and Helsinki in Finland.

Previous winners of the Health Prize have included Professor Robert A Weinberg in 2008 for his research into the origins of cancer and Sir James W Black in 1979 for his contribution to the decisive finalisation on drugs against high blood pressure and other cardiovascular diseases, as well as his discoveries in relation to the treatment of peptic ulcer and other gastro-intestinal infections.

Ark has become a world leader in developing the use of adenovirally mediated VEGF genes for the treatment of cardiovascular disease. The most advanced product, Trinam® is currently in Phase III development for the prevention of blockage in haemodialysis access grafts, and four more products are in earlier stages of development for the treatment of refractory angina, peripheral vascular disease, foetal growth retardation and wound healing. Rights to develop VEGF C and D genes in the vascular and lymphatic systems were acquired by Ark in January 2008 through the acquisition of Lymphatix Oy.

Dr Nigel Parker, Chief Executive of Ark commented: "On behalf of the Board and all staff at Ark I would like to congratulate both Professor Ylä-Herttuala and Professor Alitalo on this outstanding achievement. The whole area of VEGF biology has become increasingly important and this family of genes has wide-reaching applications in medicine. The Health Prize is an independent and robust validation of what we are doing at Ark to develop breakthrough medicines based on our deep understanding of VEGF, and we look forward to announcing further progress in this area in due course."
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flosz 5 mei 2009 16:51

9

Yeah baby Yeah.....

RNS Number : 6479R
Ark Therapeutics Group PLC
05 May 2009

Ark's Trinam® Awarded Fast Track Status by FDA

5 May 2009 - Ark Therapeutics Group plc ("Ark" or "the Company") today announces that Trinam® has been awarded Fast Track designation by the US Food and Drug Administration ("FDA"). Trinam® is Ark's novel gene-based medicine to prevent blood vessels blocking in kidney dialysis patients who have undergone vascular access graft surgery. This designation covers Trinam® as a treatment for the prevention of de novo stenosis at vascular surgical anastamoses.

Designation as a Fast Track product allows the FDA to take such actions as are appropriate to expedite the development and review of the application for marketing approval of the product. The FDA may also evaluate for filing and commence early review of portions of an application for marketing approval of a Fast Track product under certain conditions.

Trinam® is an adenovirus-mediated VEGF D gene delivered with a novel biodegradable local delivery device (EG001) and is currently undergoing Phase III development in the US under Special Protocol Assessment ("SPA"). Results from a Phase II open-label, non randomised, standard-care controlled trial of Trinam®, reported in March 2007, indicated that the access grafts of patients given Trinam® remained functional for dialysis, on average, up to three times longer than in untreated controls. Trinam® was well tolerated with no quantifiable systemic distribution of the product found and no serious side effects were exhibited other than those consistent with the nature of the operation and condition.

US regulatory review for the product comes under the responsibility of the Centre for Biologics Evaluation and Research ("CBER"), the specialist biologics division of the FDA. Trinam® has already been given Orphan Drug Status in the USA and in Europe. Ark intends to submit a rolling Biologic Licence Application (BLA) for sale and marketing approval in the US in due course.

Dr David Eckland, Research and Development Director at Ark, commented: "This is the next important milestone in the regulatory progress of Trinam®. The problem of vascular access blocking in kidney dialysis patients has been identified as one of the key medical issues to be resolved in the US and we look forward to working closely with the FDA to expedite the development and review of Trinam®."

Dr Nigel Parker, Chief Executive Officer of Ark, added: "We are very pleased that Trinam® has been designated as a Fast Track Product. Trinam® targets a $750 million market where there is a significant unmet therapeutic need and this news potentially accelerates the development of this important product."

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[verwijderd] 5 mei 2009 17:13

6

Kun jij niet gewoon , een aanvraag indienen voor 75% van het salaris van Oya .
Misschien is 100% , een terechte waardering.
Wat zijn het toch een oelewappers daaro.

josti5 5 mei 2009 17:19

6

quote:
wilb52 schreef:
Kun jij niet gewoon , een aanvraag indienen voor 75% van het salaris van Oya .
Misschien is 100% , een terechte waardering.
Wat zijn het toch een oelewappers daaro.

Hé schreeuwlelijk, het gaat om een anderman's produkt hoor!

maxen 5 mei 2009 17:38

0

quote:
wilb52 schreef:
Kun jij niet gewoon , een aanvraag indienen voor 75% van het salaris van Oya .
Misschien is 100% , een terechte waardering.
Wat zijn het toch een oelewappers daaro.

Hoe maak ik uit een positief bericht een negatief bericht?

Weer een bonuspunt! Gefeliciteerd sammie.

josti5 5 mei 2009 17:44

1

Nounou: hoe diep kan iemand vallen, om aldaar het eigen gelijk te vinden...

flosz 5 mei 2009 17:44

13

quote:
josti5 schreef:
het gaat om een anderman's produkt hoor!

Met PER.C6 inside.....komt morgen wel langs:
Ark Therapeutics, de eerste PER.C6 licentiehouder in Phase III:Trinam, Awarded Fast Track Status by FDA.

flosz 14 mei 2009 08:56

2

Ook leuk....

디지틀보사 - ‎6 hours ago‎
미국에서 영국 아크 쎄러퓨틱스(Ark Therapeutics)의 유전자 치료제인 ‘트리남’(Trinam)이 신속심사 대상으로 지정됐다.

트리남은 투석을 위해 접근혈관이식 수술을 받는 환자의 혈관협착을 예방하기 위한 목적으로, 아데노바이러스에 혈관내피성장인자 D(VEGF D)의 유전자를 실어 생분해성 콜라겐 전달기기인 ‘EG001’을 통해 국소적으로 투여한다.

이미 미국과 유럽에서 희귀약 지정을 받았으며 현재 3상 임상을 준비하고 있다.
Groot-Brittannië in de Verenigde Staten boog ssereopyutikseu (Ark Therapeutics) van de gentherapie Jane teurinam '(Trinam) werd aangewezen als een snel onderzoek. Tree voor de rest van de dialyse vasculaire toegang stenose in transplantatie patiënten om te voorkomen dat de bloedvaten in het kader van in de bloedvaten in de binnenste ahdeno virus groeifactor D (VEGF D) van biologisch afbreekbaar collageen genen die doorgegeven hem te wijten aan term "EG001" wordt gegeven door het lokaal. huigwiyak in de Verenigde Staten en Europa hebben al opdrachten voor de huidige 3-fase klinische gereed zijn.
www.bosa.co.kr/umap/sub.asp?news_pk=1...

flosz 15 mei 2009 17:02

0

Second European Country to Commence Cerepro® Treatment on Named Patient Basis

Named Patient Supply approved in Finland

London, 15 May 2009 - Ark Therapeutics Group plc (AKT:LSE) today announces that Named Patient Supply (NPS) for Cerepro® (sitimagene ceradenovec) has been approved in Finland by the National Agency for Medicines (NAM). The approval follows an application made by a neuro-surgeon in Finland for the use of Cerepro®.

Finland is the second country to approve NPS, the first being France which approved NPS in February 2009. NPS is used by clinicians when patients are faced with a terminal diagnosis and to allow the use of promising unapproved therapies after existing therapy has failed.

Cerepro®, Ark's novel gene-based medicine, is being developed as an Orphan Drug for the treatment of operable malignant glioma. The product has undergone four clinical trials and demonstrated significant efficacy benefits in patients with operable malignant glioma. A Marketing Authorisation Application (MAA) for Cerepro® is currently undergoing formal review at the European Medicines Agency (EMEA) via the centralised procedure which is the standard route for all advanced therapies.

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flosz 17 mei 2009 14:12

4

Adenovirus Vascular Endothelial Growth Factor (VEGF) Therapy in Vascular Access - Novel Trinam AGainst Control Evidence (AdV-VANTAGE)
This study is currently recruiting participants.
Verified by Ark Therapeutics Ltd, May 2009
First Received: May 7, 2009 Last Updated: May 8, 2009

Patients in renal failure on hemodialysis depend on adequate and sustained vascular access. This can be achieved by surgical placement of a synthetic polytetrafluoroethylene (PTFE) graft. These patients frequently experience graft complications arising from the development of smooth muscle cell (SMC) neointimal hyperplasia in the proximity of the graft-vein anastomosis. Such complications eventually lead to stenosis, access thrombosis and graft failure. Trinam® is being developed to prolong graft survival. It is a combination product consisting of a replication deficient Adenovirus containing the human Vascular Endothelial Growth Factor D (Ad-VEGF-D) gene and a biodegradable local delivery device (collar) made of collagen. At the end of the surgical procedure to insert the PTFE graft the collagen collar is applied around the anastomosis and sealed with a collagen surgical sealant. This procedure creates a reservoir between the site of anastomosis and the collagen collar. The adenoviral vector is then injected into this reservoir, localizing the expression of the transgene to the site of the anastomosis. Expression of VEGF-D has been shown to have a vascular protective role and inhibit SMC neointimal proliferation, therefore expression of VEGF-D should prolong graft survival.
clinicaltrials.gov/ct2/show/NCT00895479

Maternal and Fetal Medicine
The unifying aim of the research is to develop prenatal treatment of severe and life-threatening disorders using gene and cellular therapy, and to investigate the efficacy, safety and ethical issues of such treatment. This work is internationally competitive and only a few groups in the world are working in the area
Prenatal gene therapy for treatment of obstetric disorders
Fetal growth restriction and pre-eclampsia are major obstetric problems that cause substantial maternal and fetal morbidity and mortality; there is no current treatment. The underlying cause of these conditions is reduced utero-placental blood flow. In collaboration with Professors John Martin and Ian Zachary, Department of Cardio-vascular Medicine, UCL we have shown that adenovirus mediated over-expression of VEGF increases utero-placental blood flow, and increases vasorelaxation and reduces vasoconstriction in uterine vessels short term. This work was published in 2008.

We are now investigating the long term effect in normal pregnancy and evaluating safety in the mother and fetus. This work is being funded by an industrial collaboration with Ark Therapeutics Plc.

A 3 year study funded by Action Medical Research in a model of fetal growth restriction has begun. This will measure the effect on fetal growth and evaluate whether the therapy can rescue fetuses that are severely growth restricted.
Meer via:
www.instituteforwomenshealth.ucl.ac.uk/
AcademicResearch/MaternalNeonatalHealth/submenu/fetalcellandgenetherapy.html

flosz 18 mei 2009 08:39

2

Ark Therapeutics Group plc

Interim Management Statement

18 May 2009 - Ark Therapeutics Group plc ('Ark' or the 'Company') today publishes its interim management statement for the period from 1 January 2009 to date. The Company intends to report its results for the six months to 30 June 2009 on 26 August 2009.

Highlights

• Cerepro® MAA review commenced at the European Medicines Regulatory Agency ("EMEA")
• Cerepro® Named Patient Supply approved in France and Finland
• Cerepro® Phase III trial update shows results strengthening
• Trinam® awarded Fast Track status by the FDA
• Pre-clinical: multiple gene regulation technology patent filed and progress made in advancing new clinical trials

Following clearance by the FDA in the first quarter to start recruitment into the Trinam® Phase III study, the Company has been engaged in obtaining local regulatory clearances at the investigator sites and training the investigators. Patients have now entered screening and we hope to be able to report the first patient receiving treatment imminently. Earlier this month we announced that the FDA had awarded Fast Track designation to Trinam®, allowing them to work with the Company to expedite the development and review of this important product
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flosz 21 mei 2009 08:37

3

RNS Number : 6145S
Ark Therapeutics Group PLC
21 May 2009

Ark Therapeutics Group plc

Trinam® Phase III Study Enrols First Patient

London, UK, 21 May 2009 - Ark Therapeutics Group plc ('Ark' or the 'Company') announces today that the first patient has been enrolled into the US Phase III study for Trinam®. Trinam® is Ark's novel gene-based medicine to prevent blood vessels blocking in kidney dialysis patients who have undergone vascular access graft surgery. The product is an adenovirus-mediated VEGF D gene delivered with a novel biodegradeable local delivery device (EG001).

The Phase III study is a US multi-centre, randomised, controlled trial, in which the efficacy and safety of Trinam® will be investigated in patients with end-stage renal disease (ESRD) requiring vascular access for haemodialysis. Patients with ESRD will be randomised to receive either Trinam® in addition to standard care or standard care alone at the time of surgical placement of a synthetic PTFE graft for vascular access. Primary Unassisted Patency (time to any first intervention) will be the primary regulatory endpoint. Overall patency and a number of other important pre-defined clinical endpoints will also be measured.

The safety of the trial will be assessed by an independent Data and Safety Monitoring Board (DSMB) against a pre-specified set of stopping rules defined during the Special Protocol Assessment (SPA). The DSMB will also undertake a blinded 'sizing' analysis after 150 patients have been enrolled to determine the final trial size. This type of adaptive design assists groundbreaking drugs to ensure robust efficacy data are available to satisfy regulatory requirements as approval standards evolve.

Results from a Phase II open-label, non-randomised, standard-care controlled trial of Trinam®, reported in March 2007, indicated that the access grafts of patients given Trinam® remained functional for dialysis, on average, up to three times longer than in untreated controls. Trinam® was well tolerated with no quantifiable systemic distribution of the product found and no serious side effects were exhibited other than those consistent with the nature of the operation and underlying condition.

Trinam® was awarded Fast Track Status by the FDA earlier this month and has been granted Orphan Drug Status in both the US and Europe. US regulatory review for the product comes under the responsibility of the Centre for Biologics Evaluation and Research (CBER), the specialist biologics division of the FDA.

Dr David Eckland, Research and Development Director of Ark, commented: "We are very pleased to commence enrolment into the Phase III study for Trinam® which follows the Fast Track Status gained from the FDA earlier this month. There is a significant unmet therapeutic need in this indication and today's news brings us a step closer to gaining approval for a product which we believe will transform the prognosis for many patients suffering from kidney failure."

Dr Nigel Parker, CEO of Ark, added: "First patient enrolment is a significant milestone for this very important gene-based medicine and reflects the good progress we continue to make at Ark. Our whole portfolio is growing in strength and we look forward to announcing details of Trinam®'s continued progress in due course."
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flosz 17 juni 2009 15:51

0

Ark Therapeutics Group PLC
17 June 2009

Ark and AOTI sign international medical device sales collaboration on Kerraboot®

London 17 June 2009 - Ark Therapeutics Group Plc ("Ark" or "the Company") announces today that it has signed an agreement with the privately owned global woundcare company, AOTI Ltd. (AOTI), for the supply of Kerraboot® in conjunction with AOTI's new Topical Wound Oxygen Therapy, known as TWO2, for the treatment of problematic chronic wounds. The initial agreement under which AOTI will purchase Kerraboot® from Ark is for two years and includes projected sales numbers with minimum purchase commitments.

The new treatment regime combining TWO2 therapy with Kerraboot® will involve the application of AOTI's unique cyclical pressure topical oxygen therapy with the use of Ark's Kerraboot® between each treatment. TWO2 has been shown to completely heal complex wounds by correcting local tissue oxygen balance, stimulating angiogenic growth factors and the granulation of highly collagenous tissue and reducing bacterial bio-burden and peripheral oedema1. Kerraboot® provides an easy to apply and pain free interim wound management dressing. The agreement anticipates that Kerraboot® will be used extensively in lower limb wounds treated with TWO2.

Under the agreement, Ark has granted AOTI exclusive international rights to purchase Kerraboot® for use in this novel treatment approach which has demonstrated significant increases in healing rates for these problematic wounds.

The new combined TWO2-Kerraboot® regimen will be launched immediately, commencing in the US, Germany, France, Russia and the Middle East.
tinyurl.com/mfmyc2

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