Ark Therapeutics -- Ein Muss für jeden Biotechfan - 500 Beiträge pro Seite

[BrauchGeld]

Ark Therapeutics hat bereits drei Produkte auf dem Markt und drei weitere in Phase III Cerepro ,Trinam und Vitor .
Das am weitesten fortgeschrittene ist Cerepro das bei operablen Gehirntumor eingesetzt wird und bisher hervorragende Daten präsentiert hat .
Finale Phase III-Ergebnisse werden für Juli 08 erwartet falls positiv ist Kursfeuerwerk garantiert .
Cerepro ,Vitor und Trinam haben jeweils einen Umsatzpotential von 300 -400 Million GBP (~ 375 - 500 Million € ) .
Bin seit heute wieder mit 4000st (0,80 €)dabei ,bei aktuellen Kurs ist die Aktie fast geschenkt .

Hab leider nicht soviel Zeit werde aber bald mehr über Ark berichten .

Ark Therapeutics (AKT.L)

Marktkap : 130 Million GBP ( 162,2 Million € )
Cash : 65,1 Million GBP ( 81,2 Million € )
Kurs :63,50 p ( ~ 0,80€ )

Pipeline :
http://www.arktherapeutics.com/main/research_development.php…


Cerepro (malignant glioma) final Phase III resultat in Juli 08
Mehr über Cerepro
http://www.arktherapeutics.com/main/products.php?content=pro…

Trinam (haemodialysis access) start Phase III in 1H 08
Mehr über Trinam
http://www.arktherapeutics.com/main/products.php?content=pro…

Vitor (cachexia) start Phase III in 1H 08
Mehr über Vitor
http://www.arktherapeutics.com/main/products.php?content=pro…


Multicenter-Gentherapiestudie zu Glioblastomen soll nun „Machbarkeit und Sicherheit“ der präklinischen und klinischen Vorstudie bestätigen

An einer internationalen Phase-III-Gentherapiestudie zur Behandlung bösartiger Hirntumore, so genannter primärer Glioblastome, nimmt die Neurochirurgische Klinik des Frankfurter Uniklinikums unter der Leitung von Professor Dr. Volker Seifert teil. Sie ist eine von 40 Hirntumorzentren, die in Europa und Israel von einem Internationalen Beratergremium für diese Studie ausgewählt worden sind. Die Forscher erhoffen sich von dem Ansatz der Studie eine weitere Verbesserung der Prognose von Patienten mit einem Glioblastom, ein von den Gliazellen ausgehender bösartiger Hirntumor mit einer mittleren Überlebenszeit von acht bis zwölf Monaten.

In Europa werden pro Jahr etwa 29.000 Fälle mit Glioblastomen diagnostiziert. Bei 16.000 der Patienten ist der Tumor operabel. Die bisherige Therapie beruht auf einer weitestmöglichen Entfernung des Tumors. Daran schlossen sich bisher eine Radiotherapie und gegebenenfalls auch eine Chemotherapie an, die die insgesamt schlechte Prognose für die Patienten verbesserte.

Durch die seit wenigen Monaten zugelassene kombinierte Radiochemotherapie ist die mediane Überlebenszeit auf 12 bis 15 Monate verlängert worden. Auffallend ist auch eine Zunahme der Langzeitüberleber. Dennoch ist der Verlauf der Krankheit durch das Rezidivwachstum nach wie vor sehr ungünstig. Die jetzt laufende Phase-III-Studie ist ein viel versprechender Ansatz, die Prognose der Patienten weiter zu verbessern.

In dieser kontrollierten randomisierten Multicenter-Studie werden Patienten mit einem primären operablen Glioblastom eingeschlossen. Sie werden randomisiert in zwei Therapiearme. Den ersten Therapiearm bildet die Gentherapiegruppe, den zweiten die Kontrollgruppe (Operation und nachfolgende Radiochemotherapie). In der Gentherapiegruppe wird nach Abschluss der operativen Resektion in das Randgebiet des Tumors, in dem sich für den Operateur nicht erkennbar noch Tumorzellen befinden, die gentherapeutische Substanz Cerepro injiziert. Diese Substanz beinhaltet einen replikationsdefizienten adenoviralen Vektor, der das Herpes-simplex-Virus-Thymidinkinase-Gen enthält. Die verbliebenen Tumorzellen werden transfiziert und exprimieren dann das Thymidinkinasetransgen. Das Thymidinkinaseenzym phosphoryliert Ganciclovir, welches den Patienten von Tag 5 bis Tag 19 intravenös verabreicht wird. Dadurch wird ein zytotoxisches Nucleotid produziert, welches den Zelltod von aktiv in Teilung befindlichen Zellen verursacht. Danach erfolgt wie im Kontrollarm die Radiochemotherapie.

Präklinische und klinische Vorstudien haben die Machbarkeit und die Sicherheit der Therapie nachgewiesen. Zudem wurde eine signifikante Verlängerung der Überlebenszeit in der Gentherapiegruppe gegenüber der Kontrollgruppe erreicht. Um diese Ergebnisse an einer großen Anzahl von Patienten zu belegen, wurde die jetzt laufende Studie initiiert. Geplant ist der Einschluss von 250 Patienten. Endpunkte der Studie sind neben der Gesamtüberlebenszeit und der progressionsfreien Überlebenszeit auch die Überprüfung der Sicherheit, der Lebensqualität und des kernspintomographischen Progressionsnachweises.

[BrauchGeld]

Analysten sehen bei positiven Daten eine Verdreifachung des Kurses vom aktuellen Stand aus ,langfristig dürfte dann weitaus mehr drin sein .
Ich persönlich stufe die Chancen auf Erfolg für Cerepro höher ein als die 50/50 Chance vom Analyst .

Exciting times for Ark Therapeutics

Created:11 March 2008
Written by:Richard Hemming

The much anticipated data for Ark Therapeutics’ brain cancer drug, Cerepro, is due at the end of July and chief executive Nigel Parker knows what is at stake: “Once we get an approval of Cerepro the future of this company is assured.”

Nomura Code analyst Samir Devani puts the likelihood of success of the Phase III trial at 50 per cent. A failure would see a 50 per cent fall in the share price, but success is likely to see the share price north of 200p, he says.
Ark raised over £35.4m in a placing and open offer at 105p a share last November, and the company is building up a stronger early and late stage pipeline. But investors’ confidence will be increased by Dr Parker’s belief that the compelling results for Cerepro seen in Phase II - versus patients on standard treatment - will occur again in the bigger Phase III trials.

Elsewhere, Trinam, a treatment for blood vessel blockages in dialysis patients and Vitor, for cancer-related muscle wastage, are both entering Phase III trials this half.

Nomura Code expects a loss per share of 10.9p in 2008 and has a fair value of 130-140p on the shares.

[BrauchGeld]

Director Shareholdings

Notifier.......Holding.......Value*
Seppo Yla-Herttuala.......3,152,358.......£2,009,628
Nigel Parker.......2,894,579.......£1,845,294
Martyn Williams.......551,310.......£351,460
Peter Keen.......194,965.......£124,290
Dennis Turner.......155,026.......£98,829
David Prince.......16,486.......£10,510
Mark Richmond.......14,118.......£9,000


Major Shareholders

Aberforth Smaller Co's Tr 10.9%
Lansdowne Partners 9.81%
Standard Life Investments 9.41%
Invesco Asset Mgt 9.40%
GAM Int Mgmt 4.04%
Legal & General Grp 4.00%
J O Hambro Capital Group 3.57%

Shares in Issue : 205.1 million

[Popeye82]

[BrauchGeld]

Ark (gene-therapy) befindet sich in einer ähnlichen Lage wie Dendreon(cancer vaccine) beide Unternehmen könnten mit ihren Produkten die ersten im jeweiligen Markt sein .
Ark könnte aber bereits in Juli 08 einen riesigen Schritt richtung Zulassung machen wenn die finale Phase III resultate veröffentlicht werden .
Natürlich ist die Aktie risikoreich aber bei Erfolg sind satte Gewinne drin,auch im Verhältniss zu Dendreon steht Ark wesentlich besser da .

Kurs : 70p = 0,89 €


HIGHLIGHTS (März 2008)

Cerepro(R) * Phase III study completes recruitment

* Two successful Data Safety and Monitoring Board ("DSMB") <<< sehr positiv zu bewerten
meetings advise no major safety concerns and recommend
trial continuation

At the end of 2006 the DSMB had reviewed the first 133 patients
recruited into the Cerepro(R) Phase III corroborative study and recommended the
study continue as planned. In early Q2 2007 we completed recruitment of the full 250
patients and in July the DSMB again recommended continuation of the study.

* Clearance from the EMEA of historically difficult
technical barriers represents major breakthrough for
Cerepro(R) and the new gene-based therapeutic area
overall

Trinam(R) * Special Protocol Assistance (SPA) opened for Phase III
trial

* US Recombinant DNA Advisory Committee (RAC) gives early
clearance for Phase III trial, expected to commence in
H1 2008

VitorTM * Successful pre-Phase III FDA and EMEA scientific advice
meetings. Pilot Phase III trial expected to commence
H1 2008

Pre-clinical * Three gene-based products being prepared for Phase
I/IIa trials

* Ark Therapeutics-led consortium awarded Euro2.5m European
Commission grant for baculoviral vectors research

* Scavidin(R) demonstrates pre-clinical effectiveness in
third cancer model

Wound care * Wound care portfolio strengthened with the addition of
Kerraped(R)

Corporate/ * Formal grant of key patent for stroke in Europe

Commercial * Placing and Open Offer completed in November, raising
£35.4m net of expenses

* Cash and money market investments of £65.1m at 31
December 2007 (£48.4m at 31 December 2006)

Post-period events * January 2008 DSMB meeting confirms timing of preliminary
results from Phase III Cerepro(R) trial due Q3 2008

* Acquisition of Lymphatix Oy strengthens gene research
technology and secures licences for VEGF C and VEGF
D genes

* Finnish manufacturing facility completes validation
review to USA standards

* Neuropad(R) in-licensed and launched in the UK <<< Ark hat damit das 4. Produkt auf dem Markt
(see separate press release)


Summary and Outlook

In 2007 we made substantial progress. The pioneering work on regulatory
standards for gene therapy, progressing our other leads towards Phase III and
the grant of the European stroke patent are some of the most important
achievements in the history of the Company. This success, together with our
pre-clinical progress, catalysed the Placing and Open Offer which has allowed us
to strengthen considerably our balance sheet, thus securing the next stage of
the Company's development and building on our leading position in the gene
therapy area.

During 2008 we expect to maintain this momentum. Our manufacturing facility
recently achieved US production validation standards. Trinam(R) and VitorTM are
expected to enter Phase III studies and we will report the results of the
Cerepro(R) Phase III study. We already have the sales and marketing plan for
launch in place and key managers identified. 2008 should also bring further
developments in the commercialisation of our stroke patent and we expect to
introduce further wound care products to market in the UK. With the Lymphatix
acquisition and strong cash reserves we also expect to make significant progress
with the late stage pre-clinical programmes, moving them towards Phase I/IIa
development in consultation with regulators. We are very excited by our
achievements in 2007 and, whilst there are still some major challenges ahead, we
look forward to translating these plans into reality with confidence.

[BrauchGeld]

[BrauchGeld]

Die 80 cent Einstiegskurs hat sich bisher als perfekt erwiesen ...

[BrauchGeld]

Ab Juli wissen wir ob wir hier eine zweite Celgene oder ein Flop haben .

Gene therapy for high-grade glioma with an adenoviral vector containing the Herpes Simplex virus thymidine kinase gene (Cerepro™): From pre clinical studies to a randomised phase II survival study

Text
Objective
The aim of these studies was to evaluate the efficacy and safety of CereproTM (Herpes Simplex virus thymidine kinase in an adenoviral vector AdvHSV-tk) with intravenous Ganciclovir in pre clinical animal model as in patients with operable high grade glioma. Our randomised, controlled, phase II study involved 36 patients with operable primary or recurrent high-grade glioma.

Methods
Patients were randomised in phase II study either to receive CereproTM (3x1010 pfu) by local injection into the walls of the tumor cavity at the time of tumour resection, followed by intravenous ganciclovir, 5mg/kg twice daily for 14 days (n=17) or standard care consisting of radical excision (n=19). Patients in both groups with primary tumours received postoperative radiotherapy.

Results
In the phase II study, there was an increased mean survival from 39.0±19.7 (SD) in control group to 70.652.9 weeks in the treatment group (p=0.0095) following CereproTM therapy. Median survival increased from 37.7 to 62.4 weeks. The percentage increase in mean survival was 81% and median survival was 65%. This therapy was well tolerated according to adverse events, clinical chemistry, haematology and immunology. There was no evidence of any deterioration in quality of life or increased use of concomitant medications.

Conclusions
CereproTM (Herpes Simplex virus thymidine kinase in an adenoviral vector AdvHSV-tk) with ganciclovir is a novel, safe, promising therapy for operable malignant glioma.

[BrauchGeld]

Heute ist leider die Börse in London geschlossen .

[BrauchGeld]

Ich hab Adam Feuerstein von TheStreet.com eine mail bezüglich Ark Therapeutics geschickt ,ich bin gespannt ob er darauf antwortet .

[BrauchGeld]

Schöner Ausbruch nach oben

[BrauchGeld]

Es geht weiter aufwärts bis zum nächsten Widerstand(blau) .....

[BrauchGeld]

Ich hoffe das ist die vorfreude auf positive Daten ,falls positiv sind 1000p langfristig drin .

[BrauchGeld]

Ark scheint heute eine Pause einzulegen nächster Schritt wäre die 200-Tageslinie (91p) zu knacken .

[BrauchGeld]

update....

Ark Therapeutics Grp - Interim Management Statement
RNS Number : 5937U
Ark Therapeutics Group PLC
16 May 2008


Ark Therapeutics Group plc

Interim Management Statement

16 May 2008 Ark Therapeutics Group plc ('Ark' or the 'Company') today publishes its first interim management statement for the period 1 January 2008 to date. The Company intends to report its results for the six months to 30 June 2008 on 27 August
2008.

The overall performance of the business during the period has been in line with the Board's expectations.

Highlights

* Timing of Phase III Cerepro® preliminary results confirmed for Q3 2008
* Good progress made towards start of Phase III trials for Trinam® and VitorTM
* Acquisition of Lymphatix Oy strengthens gene technology research and secures access to VEGF C and VEGF D genes
* Positive opinion letter received from EMEA for Cerepro® Paediatric Investigation Plan
* Finnish manufacturing facility completes validation review to USA standards
* Ark products win inclusion on new NHS Advanced Woundcare Therapies Contract
* Neuropad® in-licensed and launched in the UK

Clinical Programmes
In Cerepro®, the major breakthroughs we achieved in 2007 with the key technical sections of the submission - CMC, pre-clinical and environmental - enable us to contemplate the filing of an application for a full licence once the results of
the Phase III corroborative study are available in Q3 2008. In the meantime, work on the Finnish expanded manufacturing facilities, commercial-scale production process and sales and marketing infrastructure have proceeded.

Discussions with the regulators during the period concerning the Phase III trials for Trinam® and VitorTM have remained positive and we anticipate being cleared to start both trials by mid-year.

Pre-clinical Programmes
The acquisition of Lymphatix Oy in January has enabled us to accelerate our plans for a number of VEGF D-based pre-clinical programmes for which clone selection and planning for toxicity studies are well-advanced.

Woundcare
The good growth seen in our woundcare sales in 2007 has been maintained in the opening months of 2008. The inclusion of Ark's products on the new NHS Advanced Woundcare Therapies Contract and the recent launch of Neuropad® give us further
confidence for the future success of this business.

Intellectual Property Portfolio
We have made continued progress in taking our key patents through the international prosecution process. Further progress has been made towards the commercialisation of the 'ACE Stroke' patent and the Company continues to receive enquiries concerning
licensing of other intellectual property in Ark's portfolio.

Cash
As we reported in our 2007 annual results announcement, the Company had £65.1m in cash and money market investments at 31 December 2007. Cash usage in the business in the opening months of 2008 has been in line with the Board's expectations
and Ark remains well-funded to build on its leading position in the gene therapy area. There have been no other significant changes in the position of the Company over the period since publication of the report and accounts for the year ended 31 December
2007.


Nigel Parker, CEO of Ark, commented:

'The progress achieved in our business in 2007 has continued in the opening months of this year. In our three late-stage clinical programmes, Cerepro® Phase III trial results have been confirmed for the third quarter and progress has been
made towards starting the Phase III trials for Trinam® and VitorTM. We have commenced work to bring a number of our pre-clinical programmes through the late stage pre-clinical work prior to taking three of them into Phase I trials. I am
delighted that the sales growth in our woundcare business reported in our 2007 annual results has been maintained in the period. With our broad range of products and strong cash position, we are well placed to continue meeting the objectives we have set.'

[BrauchGeld]

So die 200-Tageslinie(91p) haben wir hinter uns der weg ist nun frei .....

Viel Glück

[BrauchGeld]

Eine kleine Anregung :

- Bereits ende 2006 waren 130 Personen mit Cerepro behandelt worden
- Januar 2007 gabs ein Ok von der Data and Safety Monitoring Board (DSMB) die Studie wie gehabt weiter zu führen
- Im Juli 2007 waren die 250 Patienten komplett behandelt worden und erneut gabs ein Ok von der Data and Safety Monitoring Board (DSMB)
- Überlebenszeit mit herkömmlicher Standardbehandlung beträgt ca.8 Monate
- Im März 2008 zeigte sich der CEO optimistisch was Cerepro angeht

[BrauchGeld]

Ark makes significant advances with EG013 and EG014 preclinical programmes

19 May 2008 - Ark Therapeutics Group plc ("Ark" or the "Company") today provides an update on two of its preclinical programmes, EG013 and EG014. In November 2007, Ark raised £35.4 million net through a Placing and Open Offer to allow investment in a number of advanced preclinical programmes within its gene-based medicine portfolio that had promising results and the potential to move rapidly into the clinic.

EG013 is a Trinam® 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.

Fetal growth restriction, in its various forms, affects approximately 60,000 babies in the USA and Europe and is an extremely distressing condition. The work is being undertaken as a collaboration between Ark's scientists at University College, London (UCL) and the UCL Department of Obstetrics and Gynaecology. An abstract describing the work was recently presented at an American Society of Gynaecological Investigation where it won a President's Investigator award.

Commenting on the results, Professor Donald Peebles, Professor of Obstetrics and Fetal Medicine at UCL undertaking the work, said: "The results from this second set of experiments are again very encouraging. The robust science behind the gene-based product led us to believe we would see this effect but it is always exciting to have the theory confirmed. In common with many of the new types of advanced biologics treatments that are coming through, it looks as if we may be on the verge of a major treatment breakthrough in an extremely distressing medical condition."

EG014 is Ark's gene derived small molecule anti-cancer programme centred around the neuropilin 1 (NP1) receptor. Previously reported preclinical results from Ark's early leads have shown that blocking of the NP1 receptor has a triple effect, killing tumour cells, reducing blood flow to tumours and inhibiting metastatic spread of the cancer. Work this year using advanced crystallography and computational chemical modelling has led to the recent discovery and understanding of the precise NP1 receptor pocket structure and molecular binding site characteristics. Additionally Ark has completed development of novel fast screening assays, highly specific to the above mentioned receptor. These developments are significant advances which now direct Ark's chemistry to optimise the existing leads.

Commenting on this, Professor John Martin, Chief Scientific Officer at Ark, said: "The previous preclinical results with NP1 indicated its potential as a broad treatment for cancer. This precise finding had eluded us for a number of months and we are delighted to have made this discovery in such a precise and detailed manner. This allows us to continue what we believe is the last stage of our lead optimisation work in a controlled and systematic way to give us compounds with the right potency and binding specificity to take into the clinic."

Nigel Parker, CEO at Ark, added: "In the second half of last year we received strong support to progress a number of preclinical programmes and we are very pleased to report this steady and solid progress by our research groups in two of the projects. It is extremely exciting for us to see this breakthrough science move forward and the progress confirms our view that advanced molecular medicine has the potential to offer breakthrough treatments in areas of serious unmet clinical needs. We look forward to updating the market on progress with these and our other preclinical projects in due course."

[BrauchGeld]

Aberforth Partners LLP erhöht anteil von 11,3 million Aktien auf 20,8 million Aktien.........

http://moneyextra.uk-wire.com/cgi-bin/articles/2008052213270…

[BrauchGeld]

Hab mein Einsatz hier rausgeholt und in LifeCycle gesteckt , Gewinn (1000st) lasse ich weiterlaufen .

LifeCycle ist nicht so risikoreich wie Ark deshalb diese entscheidung .

[Bombenleger]

Ark Therapeutics Grp - Research Update
RNS Number : 5655V
Ark Therapeutics Group PLC
30 May 2008


Ark Commences Vitor Pilot Phase III Clinical Programme

30 May 2008 - Ark Therapeutics Group plc ('Ark' or the 'Company') today
announces that the UK and Hungarian authorities have given Clinical Trials and
Centralised Ethics Committee approvals to allow the Company to commence the
Pilot Phase III trial
(Study 208) with Vitor, Ark's product to treat cachexia (involuntary muscle
wasting) associated with cancer.

Study 208 is a blinded, randomised, placebo controlled, multicentre trial in
up to 64 patients. Recruitment is planned in five countries in Europe. The trial
will study the effect of Vitor on patients with non-small cell lung cancer who
are already
experiencing clinical signs of cachexia. Patients will be assessed for their
rate of muscle wasting during an initial blinded study run-in period of up to 6
weeks, and thereafter randomised to active or control treatment for a further 12
week period.
Total weight loss, lean body mass and other physical markers of cachexia will be
assessed using a variety of methodologies. The study results will provide data
to support the design of the final Phase III programme.

Vitor has been awarded Fast Track Status by the FDA reflecting the high
clinical need for an effective product to treat cachexia, which affects up to
70% of patients with solid tumours and is the most frequently reported cause of
death in these
patients. A Special Protocol Assessment (SPA) process was opened with the FDA in
2007. The Company is expected to enter full Phase III development in 2009
following completion of this pilot study.

A Phase II/III study of Vitor in 165 patients has already been completed in
the USA and Europe, where treatment showed a significant effect compared with
placebo in reducing the rate of daily weight loss in patients with small cell
lung and colon
cancer.

Nigel Parker, CEO at Ark, commented: 'The development of medicinal products
is a complex and difficult process, with requirements from the regulators
increasing every year. We are therefore pleased to report that we have succeeded
in meeting the
latest regulatory requirements and have received approvals to allow this
important trial to commence.'


Enquiries

Ark Therapeutics plc Tel: [phone]
Dr Nigel Parker, Chief Executive Officer
Martyn Williams, Chief Financial Officer

Financial Dynamics Tel: [phone]
David Yates / Sue Quigley


Notes to Editors

Vitor and cachexia in cancer
Vitor* is an oral small molecule therapy for the treatment of muscle wasting
(cachexia), a secondary, often fatal, condition commonly seen in patients with
cancer. The active ingredient was originally developed as a treatment for high
blood pressure
and is currently marketed in Japan and certain countries in Europe. Pre-clinical
work has shown Vitor* up-rates the ability of mitchondria to produce energy. In
addition, by working on the ubiquitin proteasome pathway, it prevents the
breakdown of muscle
proteins (actin and myosin) and reverses the impaired muscle protein production,
which both occur as a result of the action of chemicals secreted by the cancer
tumour and lead to weight loss. Ark estimates that 1.5 million new cases of
cancer cachexia
occur every year in the US and Europe yet few treatment options currently exist.


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 four marketed devices,
Kerraboot®, Kerraped®, Flaminal® and Neuropad®, 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 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, as 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 Yla-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.
This information is provided by RNS
The company news service from the London Stock Exchange

END

[Bombenleger]

Ark Therapeutics Grp - Regulatory Approval


RNS Number : 7004V
Ark Therapeutics Group PLC
02 June 2008


Ark Receives Special Protocol Assessment Approval from US FDA
for Phase III Pivotal Trial of Trinam®


2 June 2008 - Ark Therapeutics Group plc ('Ark' or the 'Company') today announces that, following full review by the US Food and Drug Administration (FDA), the application for Special Protocol Assessment (SPA) for its Trinam® Phase III trial,
filed in April 2007, has been successful and the FDA has formally given SPA approval. In parallel, the updated Investigative New Drug (IND) application for the trial has also been separately reviewed and approved by the FDA, subject to a requirement for
the Company to qualify one product release test relating to potency, prior to enrolling patients.

Trinam® is Ark's novel gene based medicine to prevent blood vessels blocking in kidney dialysis patients who have undergone vascular access graft surgery. Ark will now commence work to start the planned Phase III trial and, in addition, intends
to apply to the FDA for Fast Track Designation.

The SPA process allows Ark to work closely with the FDA to ensure the design and conduct of the Phase III development programme, including the definitive clinical objectives and data analyses, are appropriate to support a marketing licence application
(BLA). During the course of the SPA review, Ark has conducted a preclinical study and provided extra biodistribution data in an 'end-to-side' surgical procedure for placement of the graft. The results were in line with those seen previously, allowing the
Phase III trial to include this procedure alongside the existing 'end-to-end' placement procedure used in Phase II.

Trinam® is an adenovirus-mediated VEGF D gene delivered with a novel biodegradeable local delivery device (EG001). The product has already been given Orphan Drug Status in the USA and Europe. The US Recombinant Advisory Committee (RAC) gave
approval for a Phase III study in May 2007. 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.

The Phase III study will be 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® 4x1010 viral particles 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 end point and overall patency and a number of other important pre-defined clinical endpoints will also be measured. Safety will be assessed by an independent Data and Safety Monitoring Board (DSMB)
against a pre-specified set of stopping rules defined during the SPA. The DSMB will also undertake a 'sample sizing' analysis after 150 patients have been recruited to determine the final trial size. This type of adaptive design is relatively new and
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®, previously reported in March 2007, indicated that the access grafts of patients given the planned dose of Trinam® exhibited almost three times the
Primary Unassisted Patency compared with controls. Overall patency data from the Phase II study further showed Trinam® treatment resulted in grafts remaining functional for dialysis, on average, over 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.

Nigel Parker, CEO of Ark, commented: 'This is very good news at the end of what has been an extremely rigorous and detailed review by the FDA and we are delighted to have been successful in achieving SPA for this pioneering gene based medicine. The
FDA has provided constructive assistance to ensure we conduct the right study for a medical problem which is identified in the 2010 US Health Peoples Directive as of high clinical need. We will now get on with the test work alongside finalising
administration to commence the trial. We look forward to updating the market regarding Trinam®'s progress in due course.'


Enquiries

Ark Therapeutics plc Tel: [phone]
Dr Nigel Parker, Chief Executive Officer
Martyn Williams, Chief Financial Officer

Financial Dynamics Tel: [phone]
David Yates / Sue Quigley


Notes to Editors

Trinam®

Trinam® is a combination of a vascular endothelial growth factor gene in an adenoviral vector (Ad-VEGF-D) and Ark's biodegradable local delivery collagen collar device (EG001). At the end of the access graft surgery procedure, the collar is
fitted around the outside of the vein/graft join. The Ad-VEGF-D solution, which reduces the likelihood of blood clots and intimal hyperplasia, is then injected into the space between the wall of the collar and the blood vessel. This unique method of
administration of the gene localises its delivery to the target tissue site, maximising efficacy, avoiding systemic distribution and thus minimising the potential for side effects.

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 four marketed devices, Kerraboot®, Kerraped®, Flaminal® and Neuropad®, 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 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, as 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 Yla-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.

This information is provided by RNS
The company news service from the London Stock Exchange

END

[Bombenleger]

Ark Therapeutics Grp - Blocklisting Interim Review
RNS Number : 8271V
Ark Therapeutics Group PLC
03 June 2008


BLOCKLISTING SIX MONTHLY RETURN
1, Name of applicant
Ark Therapeutics Group plc
2. Name of scheme
Ark Therapeutics Group Unapproved Share Option Scheme
3. Period of return
From 3/12/2007 to 2/6/2008
4. Balance of unallotted securities under scheme from previous return
2,571,252
5. Plus: The amount by which the block scheme has been increased, if the
scheme has
been increased since the date of the last return (if any increase has been
applied
for)
Nil
6. Less: Number of securities issued/allotted under the scheme during
period
35,000
7. Equals: Balance under the scheme not yet issued/allotted at end of
period
2,536,252
Name of contact: Martyn Williams, Company Secretary
Telephone number of contact: 0207 388 7722

This information is provided by RNS
The company news service from the London Stock Exchange

END

[Bombenleger]

Ark Therapeutics - News Announcement
Ark Therapeutics Grp - Blocklisting Interim Review
RNS Number : 8273V
Ark Therapeutics Group PLC
03 June 2008


Ark Therapeutics Group plc
3 June 2008

BLOCKLISTING SIX MONTHLY RETURN
1. Name of applicant
Ark Therapeutics Group plc
2. Name of scheme
Ark Therapeutics Group Enterprise Management Incentive Share Option Plan
3. Period of return
From 3/12/2007 to 2/6/2008
4. Balance of unallotted securities under scheme from previous return
1,021,683
5. Plus: The amount by which the block scheme has been increased/ if the
scheme has
been increased since the date of the last return (if any increase has
been applied for)
Nil
6, Less: Number of securities issued/allotted under the scheme during
period
82,250
7. Equals; Balance under the scheme not yet issued/allotted at end of
period
939,433
Name of contact: Martyn Williams, Company Secretary

Telephone number of contact: 0207 388 7722


This information is provided by RNS
The company news service from the London Stock Exchange

END

[Bombenleger]

Ark Therapeutics Grp - Blocklisting Application
RNS Number : 1681W
Ark Therapeutics Group PLC
06 June 2008


Block Listing Application


London, 6 June 2008: Ark Therapeutics Group plc (LSE: AKT) announces that it has
made a block listing application for the admission of 2,000,000 ordinary shares
of 1 pence each (the 'Shares') to the Official List of the UK Listing Authority
and to
trading on the London Stock Exchange's market for listed securities.

It is expected that admission to listing of the Shares will take place on 9 June
2008.

The Shares will rank pari passu with the existing ordinary shares of 1 pence
each in the share capital of the Company and may be issued pursuant to the
following share option schemes:


Share option scheme Number of Shares

Ark Therapeutics Group 2005 Long Term Incentive Plan 1,000,000
Ark Therapeutics Group Approved Share Option Plan 1,000,000


Enquiries:

Ark Therapeutics Group plc
Martyn Williams, Company Secretary [phone]


This information is provided by RNS
The company news service from the London Stock Exchange

END

[Bombenleger]

RNS Number : 9473W
Ark Therapeutics Group PLC
18 June 2008


EG011 (refractory angina) demonstrates ability to grow new blood vessels and
restore heart function following heart attack


18 June 2008 - Ark Therapeutics Group plc ('Ark' or the 'Company') announces
today that EG011, its gene-based medicine being developed for refractory angina,
has demonstrated an ability to grow new blood vessels and restore heart function
following a
heart attack (myocardial infarction). This was achieved during the final
comparative gene selection work carried out by Ark's scientists in Finland in a
second preclinical therapeutic proof-of-principle study.

After a heart attack and successful recovery, an estimated 200,000 patients per
annum in the US and Europe are left with a stable heart condition but with chest
pain occurring after mild exertion or even when resting, despite being given all
existing
treatments (refractory angina). This is because heart muscle, usually around the
area that died during the heart attack, does not have sufficient blood supply to
oxygenate the muscle properly (ischaemic myocardium).

EG011, containing shortform Vascular Endothelial Growth Factor D (VEGF D*N*C),
induced a four fold increase in capillaries, which were haemodynamically
functional at 21 days with no regression. 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 occurred, a highly significant result.

Study details

The study (n=50) compared four different types of gene in Ark's established
adenoviral vector in an acute heart attack model. A non active 'marker' gene
(lacZ) in the same adenoviral vector was used as a control. Following infarction
of the left
ventricle wall, the ventricle was first electrically 'mapped' from inside the
heart to precisely identify the affected muscle area and the gene constructs
were then injected directly into the area of heart muscle around the infarct
which was deficient in
blood and had impaired function (ischaemic myocardium). The various genes, which
had all been shown previously to have some effect in either human or
experimental trials, were compared specifically in terms of ability to grow new
blood vessels
(angiogenesis), the functionality viability (perfusion), stability and
persistence of the new blood vessels and ability of the heart to pump blood
(ejection fraction).

VEGF D*N*C, which had been identified by Ark as promising in a healthy heart
model (August 2007), showed superiority to the other VEGF forms producing a four
fold increase (p=0.0001) in the mean capillary area adjacent to the infarct
within six days
of injection. This effect was maintained out to 21 days with no signs of
regression nor evidence of arteriole formation. A transient small increase (50%
lower than VEGF A) in accumulation of pericardial fluid was evident in the
treated area at day 6
following new capillary formation and this level had returned to control levels
by day 21. The left ventricle ejection fraction, which had dropped from nearly
70% before infarct to 46% after infarct, rose by over 16% (p=0.0002) with EG011
treatment,
representing restoration of nearly 90% of the ventricular function. This
compared favourably to a non significant rise of around 2% in marker gene
controls. EG011 appeared well tolerated with no differences in serious adverse
events observed between
active and control groups.

John Martin, Professor of Cardiovascular Medicine at University College London
and Consultant Chief Scientific Officer at Ark, commented: 'EG011's biology
indicates it is the right gene to be effective in refractory angina where we
need new functional
blood vessels. Safe transient expression through Ark's proven adenoviral vector
is also logical because we need short term angiogenesis. The improvement in the
heart's ability to pump blood with EG011 is many times better than that
published in the
results for successful stem cell trials where on average around a three percent
increase has been achieved. This early evidence suggests EG011 has the potential
to be a major advance in the treatment of angina and in aiding recovery from the
consequences
of a heart attack.'

Nigel Parker, CEO of Ark, added: 'Our first work was in healthy hearts and we
have now taken that work further in a heart attack model representative of the
disease and completed the gene comparisons. We could not have expected better
results at this
stage, which are consistent with the biology and will be published in a
peer-reviewed article in due course. We are now moving to final clone selection
and GMP production, so we can undertake the final toxicology work ahead of
entering Phase I human
studies.'

Enquiries

Ark Therapeutics Group plc Tel: [phone]
Dr Nigel Parker, Chief Executive Officer
Martyn Williams, Chief Financial Officer

Financial Dynamics Tel: [phone]
David Yates / Sue Quigley


Notes to Editors

Refractory angina and VEGF
Gene scientists, including those at Ark, have tried to grow new blood vessels
for refractory angina by putting genes (VEGF A and VEGF121, VEGF C, VEGF D
variants) into the coronary artery and heart muscle with some, but limited,
success so far. A new
catheter system which maps the function of the inside of the heart (NOGA system)
to locate the ischaemia is now commercially available and also allows direct
injection of a therapeutic locally into the problem area. This has allowed
testing of the
different VEGF gene variants by Ark scientists in models of myocardial ischaemia
and to supplement previous knowledge in models of peripheral limb ischaemia.
This work has shown that where previously tried VEGF variants can grow new blood
vessels, these
are not properly functional and leakage causing oedema occurs.

More recently work by Ark has resulted in EG011 being developed, which shows
significant prospects for the treatment of refractory angina in this system.
This has been achieved by optimising the receptor binding properties of the gene
to produce more
angiogenesis and minimal oedema. Sharing the same adenoviral delivery platform
as Trinam® and Cerepro®, the bulk of the key chemistry and
manufacturing development work is already established and shown to be acceptable
to regulators and
development into man by Ark is expected to be relatively rapid compared to
historical timeframes.

About Ark

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 four marketed devices,
Kerraboot®, Kerraped®, Flaminal® and Neuropad®, 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 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, as 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
Yla-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.


This information is provided by RNS
The company news service from the London Stock Exchange

[Bombenleger]

Ark Therapeutics Group plc




EMEA Gene Therapy Working Party gives positive feedback on EG013 for foetal growth restriction on pre-clinical toxicology and Phase 1 study




London , UK , 16 July 2008 - Ark Therapeutics Group plc (" Ark " or the "Company") today announces that it has received positive feedback from the EMEA Gene Therapy Working Party (GTWP) regarding the pre-clinical toxicology and Phase 1 trial requirements for EG013, an adenovirally mediated VEGF based product, being developed for foetal growth restriction. The GTWP commented on the nature of the pre-clinical models, toxicology and the design of a Phase 1 trial.




The GTWP clarified the indication (severe foetal growth restriction), the method of administration (imaging guided catheter introduced via the femoral vessels in the groin) and commented on a programme of in vivo model and in vitro tissue work incorporating biodistribution and germ line integration. The GTWP rapporteur did not have major concerns with regard to the Phase 1 trial proposed by Ark , with neonatal outcome being an efficacy endpoint.




Foetal growth restriction is an often terminal condition in which insufficient blood supply via the placenta results in serious growth retardation, leading to premature death or undesired termination of a baby 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 two trials of EG013 in a pre-clinical model of placental blood flow have shown that a single treatment with EG013, given directly into the mother's uterine artery, increased blood flow to the placenta by 25%, and that the effect is maintained for 50 days. Preliminary biodistribution results using immuno-histochemical techniques have indicated that there is no transfer of the gene into the foetus in the first days. If confirmed in human studies, a therapy with this magnitude and duration of effect could allow the foetus to grow satisfactorily to a stage where caesarean delivery of a healthy baby could be reliably performed. Ark is currently undertaking work to select the optimal VEGF gene variant for EG013 and expects to complete this in early Q4 prior to commencing final pre-clinical work.




Foetal growth restriction, in its various forms, affects approximately 60,000 babies in the USA and Europe . The work is being undertaken as a collaboration between Ark 's scientists at University College , London (UCL) and the UCL Department of Obstetrics and Gynaecology.




Commenting on the meeting with the GTWP, Dr David Eckland, Director of Research and Development at Ark , said: "Foetal growth restriction is a very distressing condition and EG013 has already shown early signs of promise. The response from the GTWP is encouraging and the guidance they have given us will be very helpful in finalising the pre-clinical development and Phase I human study."




Nigel Parker CEO at Ark added: "We are very pleased to receive this input from the GTWP. Their support is further validation of our gene-based medicine technology and expertise and we look forward to progressing this programme with our collaborators."




For further information:




Ark Therapeutics Group plc Tel: + 44 (0)20 7388 7722

Dr Nigel Parker, CEO

Martyn Williams, CFO




Financial Dynamics Tel: [phone]

David Yates

Susan Quigley




Notes to Editors




About 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 four marketed devices, Kerraboot®, Kerraped®, Flaminal® and Neuropad®, 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 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, as 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.








This information is provided by RNS
The company news service from the London Stock Exchange

[BrauchGeld]

Jawohlllllll endlich klappts mal yesssssssss

Ark Therapeutics Group PLC 30 July 2008

Preliminary Cerepro(R) Phase III results meet primary endpoint


Secondary endpoints yet to be established with 45% of patients still alive -
London, UK 30 July 2008 - Ark Therapeutics Group plc (AKT:LSE) today announces that the preliminary analysis of Study 904, a Phase III study of Cerepro(R), its novel gene-based therapy being developed as an Orphan Drug for the treatment of operable primary malignant glioma, demonstrates that the trial has met its primary endpoint. Cerepro(R) treatment resulted in significant improvements in median survival on the primary endpoint compared with various control groups. In the secondary endpoints, with 45% of patients still alive, benefits have yet to be established.

Study 904 was a multicentre, standard care controlled, pivotal trial in 236 patients designed, following advice from the EMEA, to confirm the safety and efficacy of Cerepro(R) in patients with operable high grade glioma (brain cancer) against current standard care treatment options. Patients were randomised to either standard care plus Cerepro(R) or standard care alone. Standard care was surgery and radiotherapy or surgery and radiotherapy followed by temozolomide, depending on the investigating centres' standard practice and patient suitability, giving four treatment groups. This allowed comparison of the efficacy of Cerepro(R) and temozolomide in the same trial without denying patients what physicians considered the appropriate established standard care. 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).

The overall combined controls primary endpoint analysis in the Intention to Treat (ITT) population (n=236) compared Cerepro(R) with and without temozolomide against controls with and without temozolomide. It showed a 42 day improvement in median survival (310 days vs 268 days) and the improvement over standard care reached significance (p<0.032). The analysis was performed approximately 14 months after completion of recruitment.

On the primary endpoint, the group given Cerepro(R) and temozolomide showed an improvement of 68% in median survival time compared with standard care surgery and radiotherapy controls (350 days vs 208 days). Against the same controls, treatment with Cerepro(R) alone showed an improved median survival trend approaching 50%, similar to those given treatment with temozolomide alone after surgery and radiotherapy (300 days and 307 days respectively vs 208 days with standard care). Improvements in the combined Cerepro(R) and temozolomide treatment group (n=58) and temozolomide alone group (n=76) were significant (p<0.05). In the smaller Cerepro(R) alone treatment group (n=61), the effect is approaching significance (p<0.065) with 16% still to report an event. Of the total 53 patients still to report an event, only 7 are in the surgery and radiotherapy control group and thus confidence intervals and statistical significance levels in all treatment groups might be expected to improve with time.

On the secondary endpoints, which include MRI based progression, all-cause mortality, safety and quality of life, the effects of Cerepro(R) treatment have yet to be established with around 45% of patients still alive. Data from a further time point analysis are needed to fully elucidate this.

Whilst increases were observed in hemiparesis, aphasia and pyrexia following therapy, the serious adverse event reports for Cerepro(R) were in line with those in previous studies, indicating that the product has an acceptable safety profile.

An updated analysis will be conducted in January 2009 according to the plan and all patients with be tracked until death in accordance with the gene therapy regulations.

The results of the study are expected to be presented at the European Association of Neuro-Oncology in Barcelona on 11-14 September 2008.

Commenting on the results Dr David Eckland, R&D Director at Ark, said: "We are very gratified that Cerepro has demonstrated efficacy in this multi-centre Phase III gene therapy study. This is in keeping with our experience and expectation of the product and we now have further evidence to show Cerepro(R) has an anti-cancer effect. Our next steps are to complete the full analysis and meet with our EMEA rapporteur to determine the way forward."

Dr Nigel Parker, CEO at Ark, added: "This is the first gene therapy product to successfully reach its primary endpoint in a major Phase III trial. With a number of patients in the trial still to report an event, there is a substantial amount of further information to come and we will update the analysis after the turn of the year in parallel with our regulatory activities. Malignant glioma is one of the most aggressive of all human diseases and to have seen a positive effect for Cerepro(R) in this disease area is very encouraging. Ark's adenoviral delivery technology has the potential to deliver a new era of gene-based therapies for acute and chronic human disease."

[Fruehrentner]

hört sich gut an!

Thread Lesezeichen

[Fruehrentner]

Antwort auf Beitrag Nr.: 34.630.916 von Fruehrentner am 01.08.08 13:31:15

Preliminary Cerepro Phase III Results Meet Primary Endpoint
31 Jul 2008

Secondary endpoints yet to be established with 45% of patients still alive

London, UK | July 30, 2008 | Ark Therapeutics Group plc (AKT:LSE) today announces that the preliminary analysis of Study 904, a Phase III study of Cerepro (R) , its novel gene-based therapy being developed as an Orphan Drug for the treatment of operable primary malignant glioma, demonstrates that the trial has met its primary endpoint. Cerepro (R) treatment resulted in significant improvements in median survival on the primary endpoint compared with various control groups. In the secondary endpoints, with 45% of patients still alive, benefits have yet to be established.

Study 904 was a multicentre, standard care controlled, pivotal trial in 236 patients designed, following advice from the EMEA, to confirm the safety and efficacy of Cerepro (R) in patients with operable high grade glioma (brain cancer) against current standard care treatment options. Patients were randomised to either standard care plus Cerepro (R) or standard care alone. Standard care was surgery and radiotherapy or surgery and radiotherapy followed by temozolomide, depending on the investigating centres' standard practice and patient suitability, giving four treatment groups. This allowed comparison of the efficacy of Cerepro (R) and temozolomide in the same trial without denying patients what physicians considered the appropriate established standard care. 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).

The overall combined controls primary endpoint analysis in the Intention to Treat (ITT) population (n=236) compared Cerepro (R) with and without temozolomide against controls with and without temozolomide. It showed a 42 day improvement in median survival (310 days vs 268 days) and the improvement over standard care reached significance (p<0.032). The analysis was performed approximately 14 months after completion of recruitment.

On the primary endpoint, the group given Cerepro (R) and temozolomide showed an improvement of 68% in median survival time compared with standard care surgery and radiotherapy controls (350 days vs 208 days). Against the same controls, treatment with Cerepro (R) alone showed an improved median survival trend approaching 50%, similar to those given treatment with temozolomide alone after surgery and radiotherapy (300 days and 307 days respectively vs 208 days with standard care). Improvements in the combined Cerepro (R) and temozolomide treatment group (n=58) and temozolomide alone group (n=76) were significant (p<0.05). In the smaller Cerepro (R) alone treatment group (n=61), the effect is approaching significance (p<0.065) with 16% still to report an event. Of the total 53 patients still to report an event, only 7 are in the surgery and radiotherapy control group and thus confidence intervals and statistical significance levels in all treatment groups might be expected to improve with time.

On the secondary endpoints, which include MRI based progression, all-cause mortality, safety and quality of life, the effects of Cerepro (R) treatment have yet to be established with around 45% of patients still alive. Data from a further time point analysis are needed to fully elucidate this.

Whilst increases were observed in hemiparesis, aphasia and pyrexia following therapy, the serious adverse event reports for Cerepro (R) were in line with those in previous studies, indicating that the product has an acceptable safety profile.

An updated analysis will be conducted in January 2009 according to the plan and all patients with be tracked until death in accordance with the gene therapy regulations.

The results of the study are expected to be presented at the European Association of Neuro-Oncology in Barcelona on 11-14 September 2008.

Commenting on the results Dr David Eckland, R&D Director at Ark , said: "We are very gratified that Cerepro has demonstrated efficacy in this multi-centre Phase III gene therapy study. This is in keeping with our experience and expectation of the product and we now have further evidence to show Cerepro (R) has an anti-cancer effect. Our next steps are to complete the full analysis and meet with our EMEA rapporteur to determine the way forward."

Dr Nigel Parker, CEO at Ark , added: "This is the first gene therapy product to successfully reach its primary endpoint in a major Phase III trial. With a number of patients in the trial still to report an event, there is a substantial amount of further information to come and we will update the analysis after the turn of the year in parallel with our regulatory activities. Malignant glioma is one of the most aggressive of all human diseases and to have seen a positive effect for Cerepro (R) in this disease area is very encouraging. Ark 's adenoviral delivery technology has the potential to deliver a new era of gene-based therapies for acute and chronic human disease."

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

High grade glioma

High grade glioma (malignant glioma) is a devastating and fatal form of tumour that is usually confined to the brain. The current standard therapy involves surgically removing the solid tumour mass (when possible) and initiating radiotherapy and/or chemotherapy. Even with the latest approved treatments, most patients die within 12-15 months of diagnosis. Little therapeutic progress has been made in recent years and the prognosis for malignant glioma patients is poor. A high unmet clinical need exists for new treatments that prolong life in this devastating disease. It is estimated that there are approximately 16,000 cases of malignant glioma in the EU which are operable.



Cerepro (R)

Cerepro (R) is an adenoviral mediated gene based medicine (ad.HSV tk) given by multiple injections into the healthy brain tissue of patients following surgical removal of the solid tumour mass. In the following days ganciclovir is given intravenously. Once treated, healthy brain cells surrounding the site where the tumour was removed express the enzyme thymidine kinase. This converts the ganciclovir to a substance which specifically kills dividing cells. The healthy neurones surrounding the tumour in the brain are non-dividing and are therefore not susceptible to this substance. In this way Cerepro (R) harnesses healthy brain cells to help prevent a new tumour from growing.

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 four marketed devices, Kerraboot (R) , Kerraped (R) , Flaminal (R) and Neuropad (R) , and three further lead pharmaceutical products in late stage clinical development: Cerepro (R) , Vitor (TM) , and Trinam (R) , 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 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, as 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 Yla-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.

SOURCE: Ark Therapeutics Group plc

[MaatMod]

Für eine aktuelle Diskussion enthistorisiert.

MfG MaatMOD

[Fruehrentner]

Antwort auf Beitrag Nr.: 36.985.706 von MaatMod am 17.04.09 08:45:37

danke.

[Fruehrentner]

Bei ARK scheint sich was zu rühren, Talsohle beim Kursverlauf könnte hinter uns liegen. Dazu passt folgende Meldung vom 07.04.


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.'

http://investors.arktherapeutics.com/servlet/HsPublic?contex…

[BrauchGeld]

Diese super Nachricht hatte ich noch gar nicht gepostet Cerepro(Hirnkrebs) wird inzwischen per "NAMED PATIENT" verkauft damit steigen auch die Chancen enorm für eine EU-Zulassung im 4Q 2009 .

Umsatzpotential für EU liegt bei min 300-500 Mio€

Ark Therapeutics (AKT.L)
Marktkap: 114 Mio€ <<< Ziemlich günstig
Cash : 45 Mio€


France gives first approval for Named Patient Supply of Cerepro®

London, UK 16 February 2009 - Ark Therapeutics Group plc ("Ark" or the "Company") (AKT:LSE) today announces that the first Named Patient Supply (NPS) for Cerepro® has been approved by the French Medicines Control Agency (AFSSAPS) following a 'nominative' ATU application (Autorisation Temporaire d'Utilisation) made by a neuro-surgeon in France. Cerepro® (sitimagene ceradenovec), Ark's novel gene-based medicine, is being developed as an Orphan Drug for the treatment of operable malignant glioma.

Named Patient Supply through the ATU process in France is granted on an exceptional and temporary basis, for the use of a medicinal product without a marketing authorisation in the treatment, prevention or diagnosis of serious or rare diseases where no suitable therapeutic alternative exists and when the benefit/risk ratio of the medicinal product is presumed positive.

An earlier application to make Cerepro® available through the ATU process was denied in France in 2007. Since then Ark has completed Phase III development and has also filed a Marketing Authorisation Application (MAA) with the European Healthcare and Medicines Evaluation Agency (EMEA).

The Phase III study of Cerepro®, which completed in July 2008, showed that treatment with Cerepro® resulted in a significant therapeutic benefit, supporting the results of the previous Phase II clinical studies.

The MAA for Cerepro® was filed by Ark in late 2008 and the Company recently announced it had cleared the validation stage. The MAA is now undergoing formal review via the centralised procedure which is the standard route for all advanced therapies.

Dr David Eckland, R&D Director of Ark commented: "Cerepro® consistently demonstrates clinical benefits in trials and represents a much needed treatment for operable glioma. Ark is now receiving an increasing number of requests to treat patients with Cerepro® and we are delighted that this first approval has been given in France. The decision to approve on a Named Patient Supply demonstrates the increasing recognition of the utility of the product as well as the confidence amongst the neuro-surgeon community to use it."

Dr Nigel Parker, CEO of Ark, said: "We are very pleased with this initiative. There remains a significant unmet need in patients with malignant glioma and approval on a named patient basis is a logical step to making the product more widely available. This is an important milestone and another first for Ark as we believe it is the first time a gene medicine has been approved for use in a Named Patient Supply programme in Europe."

[BrauchGeld]

Ich sags nochmal Ark Therapeutics schreibt mit der Zulassung im 4Q 2009 geschichte , die werden das erste Unternehmen in Europa sein die Gen-Medizin für Krebskranke verkaufen .
Noch ist AKT ein Schnäppchen ...

Kurs aktuell bei 52p ..Nomura gibt einen fairen Kurs zwischen 130p -140p !!!!!!!

07:43GMT 7April2009-Ark Therapeutics up on drug hopes
-----------------------------------------------------

Shares in Ark Therapeutics jump 15 percent to 48.25 pence as the biotech company gives a positive update on results from a Phase III study with its key gene-based medicine Cerepro for brain cancer.


"Importantly, the company has highlighted that significance levels of the data have improved," says Nomura Code analyst Samir Devani, reiterating a "buy" recommendation on the stock with a fair value range of 130-140 pence.

[asics01]

Antwort auf Beitrag Nr.: 37.061.932 von BrauchGeld am 29.04.09 13:50:13

Ich sags nochmal Ark Therapeutics schreibt mit der Zulassung im 4Q 2009 geschichte
sofern sie die zulassung erhalten

[BrauchGeld]

Antwort auf Beitrag Nr.: 37.061.971 von asics01 am 29.04.09 13:54:15

Warum sollten die es nicht tun ?????

Frankreich hat ja schon den ersten schritt getan lies mal die Nachricht oben .
EMEA hat bereits bestätigt das wenn die Daten positiv sind die dann auch die Zulassung erhalten .
Die Daten sind Positiv und Cerepro ist auch wesentlich besser als die Standart-Therapie .


Präsentation März 2009
http://investors.arktherapeutics.com/pdf/Prelims_Results_200…

Und hier noch die fette Pipeline
http://www.arktherapeutics.com/main/research_development.php…

[Fruehrentner]

Auch chartmäßig sieht es nach einer abgeschlossenen Bodenbildung aus, es riecht durchaus nach einer bevorstehenden V-förmigen Kursbewegung.

ARK werd' ich mal genauer unter die Lupe nehmen.


P.S. Alles ohne Gewähr! Aktien können steigen oder fallen und zum Totalverlust führen!

[BrauchGeld]

Erhält Ark die Zulassung im 2.Halbjahr (danach sieht es aus) bedeutet das Ark es endgültig geschafft hat dann sind auch Kurse bis 10€ möglich .
Also wer den Einstieg bei Dendreon verpasst hat kann hier sein Glück versuchen wobei ich persönlich Ark für das bessere Investment halte ..

Ark Therapeutics (AKT.L)
Marktkap: 114 Mio€
Cash : 45 Mio€

Newsflow 2009

Cerepro® << 300 - 500 Mio€ potential

• MAA decision 3Q - 4Q 2009
• EU commercial launch strategy
finalised
• International deals

Trinam® << 700 Mio US$ + potential

• Phase III trial enrolment starts
• Fast-track designation
• Phase III update
• Prepare rolling NDA application

VitorTM << 500 Mio US$ + potential

• Phase III pilot trial initial results read
out
• Determine Phase III strategy

[BrauchGeld]

Fast track status für Trinam das ist eine sehr gute nachricht ...
Wenn alles gut geht dürfte Trinam nächstes Jahr am Markt erhältlich sein ...

Noch ist Ark billig .....


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."

[Fruehrentner]

Und jeden Tag gehts seit dem Kurstief ein kleines bisschen stetig nach oben. Spricht wohl für einen V-förmigen Kursverlauf.

PS: Bin (noch) nicht investiert.

[BrauchGeld]

Antwort auf Beitrag Nr.: 37.097.030 von Fruehrentner am 05.05.09 11:06:03

4 Produkte am Markt plus 3 weitere in PIII und zusätzlich ist Ark Therapeutics führend in sachen Gentechnik .

Cerepro (hirnkrebs) steht vor der Zulassung in Europa(3Q oder anfang 4Q) das wäre ein durchbruch für Ark .

Ark Therapeutics (AKT.L)
Marktkap: 114 Mio€
Cash : 45 Mio€

[Fruehrentner]

Antwort auf Beitrag Nr.: 37.105.457 von BrauchGeld am 06.05.09 10:08:41

@BrauchGeld,

orderst Du ARK in Deutschland oder an der Heimatbörse?

[BrauchGeld]

Nach Frankreich gibt jetzt auch Finnland das OK für Cerepro ...

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.


Dr Nigel Parker, CEO at Ark, said: 'We are very pleased to report this second NPS approval. It is encouraging to see surgeons who have experience of the drug in clinical trials wanting to use the product in normal clinical practice. Glioma is a terrible disease with a poor prognosis and as such is an area of medicine where new treatments are much needed.'

[Fruehrentner]

schaut euch mal an, wie XOMA heut abgeht, nachdem letzte Nacht die FDA-Zulassung für Cimzia gegen Rheumatoide Arthritis gab!

[BrauchGeld]

Nur die eine erforderliche PIII Studie für Trinam hat nun begonnen und bereits zum Jahresende beginnt Ark dank "Fast Track" den Zulassungsantrag einzureichen .

Ausblick 2009

Cerepro (Hirnkrebs) EU-Zulassung im 3Q oder anfang 4Q 2009
Vitor (Kachexie) Pilot-PIII resultat im 2H 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."

[buy-out]

Ark ist meiner Meinung nach eine der Top-Stories im 2. Halbjahr.
An einer Zulassung von Cerepro zweifelt wohl kaum jemand, nachdem
Frankreich und Finnland schon den ersten Schritt mit der Zulassung
auf named patient basis getan haben. Bleibt nur die Frage, ob Ark nach der
Zulassung noch unter oder schon über 100 pence notieren wird.

[buy-out]

Gestern und heute sind die Umsätze in London in die Höhe geschnellt.
Vielleicht deutet dies auf eine kommende Nachricht...

[Fruehrentner]

Gibts was Neues zu ARK?

[buy-out]

Ark receives positive feedback from MHRA scientific advice meeting on EG013 for foetal growth restriction

London, UK, 4 September 2009 - Ark Therapeutics Group plc ("Ark" or the "Company") today announces that it has received positive feedback from a formal scientific advice meeting with the Medicines and Healthcare products Regulatory Agency ("MHRA") regarding the pre-clinical toxicology and Phase I trial requirements for EG013, an adenovirally mediated VEGF based product being developed to treat severe foetal growth restriction ("FGR"). The MHRA commented on the nature of the pre-clinical models, toxicology programme and the design of a Phase I trial.

The MHRA concluded that the choice of species and overall design of the toxicology programme, including a series of in vitro studies using human placenta, are suitable to support a Phase I study. The nature and quality of the proposed vector are also suitable, and the release characteristics for the vector were clarified. The outline design of the Phase I study was considered suitable for a first-in-man study, and the entry criteria were clarified.

Severe foetal growth restriction is often a terminal condition in which insufficient blood supply to the placenta results in serious growth retardation, leading to premature death or undesired termination of a baby or long term neurological problems in surviving infants. The problem is usually first diagnosed around 20 weeks into pregnancy and at present there is no effective treatment.

Results from the first two trials of EG013 in a pre-clinical model of placental blood flow have shown that a single treatment with EG013, given directly into the mother's uterine artery, increased blood flow to the placenta by 25%, and that the effect was maintained for 50 days. Biodistribution data have shown no long term presence of the vector in the foetal tissues, as is essential for this form of gene therapy. If this efficacy is confirmed in human studies, a therapy with this magnitude and duration of effect could allow the foetus to grow satisfactorily to a stage where caesarean delivery of a healthy baby could be reliably performed. Ark has chosen the short form of VEGF-D as the most suitable agent to be used in FGR. The gene for this agent will be delivered using the standard Ark adenoviral platform, as developed in the Company's Kuopio centre. Work on this project is continuing in both Finland and the UK.

Foetal growth restriction, in its various forms, affects approximately 60,000 babies in the USA and Europe. The work is being undertaken as a collaboration between Ark's scientists at University College London (UCL) and the UCL Department of Obstetrics and Gynaecology. In addition, Ark has formed a collaboration with the Department of Maternal and Foetal Medicine at the University of Manchester, to utilise their expertise in assessing the effect of EG013 on human placenta in vitro.

Commenting on the meeting with the MHRA, Dr David Eckland, Director of Research and Development at Ark, said: "Foetal growth restriction is a very distressing condition and EG013 has already shown early signs of promise. The meeting with the MHRA is very encouraging and allows us confidently to continue the development of EG013 through the pre-clinical stage to a Phase I human study."

Dr Nigel Parker, CEO of Ark, added: "We are very pleased to receive this input from the MHRA. Their support is further validation of our gene-based medicine technology and expertise and we look forward to progressing this programme with our collaborators."

[buy-out]

Barclays hat aufgestockt und hat die 5%-Schwelle überschritten.
Und das kurz vor der Cerepro-Entscheidung. Gute Wahl!

[buy-out]

Ark announces further Cerepro® Phase III results to be presented by Investigator at Society of Neuro-Oncology Conference in New Orleans


London, UK, 14 October 2009 - Ark Therapeutics Group plc ("Ark" or the "Company") today announces that further results from its Phase III study (ASPECT) of Cerepro®, the Company's novel gene-based therapy for the treatment of malignant glioma, will be presented at the American Society of Neuro-Oncology Conference in New Orleans on 22 October 2009.

The results update will be presented by Professor Zvi Ram, of the Tel Aviv Medical Centre, Israel, one of the principal investigators for the ASPECT Study, at the Top Scoring Abstracts Session of the Conference between 2.45pm and 3.00pm CDT. Ark will also sponsor a satellite symposium for healthcare professionals at the Conference later in the day entitled, "Future Treatment of High Grade Glioma (HGG)" chaired by Professor Manfred Westphal, of University Hospital, Hamburg. Professor Manfred Westphal will also present an update on the Cerepro® clinical programme. Other scheduled speakers include Professor Martin van den Bent, of Erasmus MC, Rotterdam and Professor Zvi Ram who will review the current and future management of HGG.

Data from the conference will be available on the Company website at the end of the abstract presentation.

[BrauchGeld]

EU-Zulassung ist nur noch wenisge Tage entfernt .Credit Suisse scheint auch Positiv für Cerepro zu sein die geben ein Kursziel von 212p an <<< aktueller Kurs liegt gerade mal bei 36p !!!!!!!!!!!!!!


936 GMT [Dow Jones] Credit Suisse cuts Ark Therapeutics (AKT.LN) price target to 212p from 235p after overhauling its financial modeling and omitting potential intellectual property revenues. That said, thinks a positive outcome regarding the European approval of Cerepro could be an upcoming trigger and the risk/reward is positive here. Overall has a positive view of Cerepro's phase III data although admits this is based on only having seen a limited amount of the data. Says the implied probability of approval by the capital markets is 15%. Keeps at outperform.

[BrauchGeld]

Die letzten Tage in 2009 werden sehr spannend ,uns erwartet noch abgesehen von der möglichen EU-Zulassung für Cerepro auch Phase III Interim-Daten von Vitor(cachexia) .

Positiv ist auch das der Aktienanteil der Intis von Anfang 2009 bis jetzt von ca 50% auf über 70% gestiegen ist .

Marktkap liegt bei 86 Mio€ das ist für so eine Pipeline und erst recht wenn die Zulassung für Cerepro kommt,das ca bis zu 500M€ Jahresumsatz sorgen könnte ,Superbillig .

http://arktherapeutics.hemscott.com/servlet/HsPublic?context…

11 November 2009
Ark Therapeutics Group plc


Interim Management Statement


11 November 2009 - Ark Therapeutics Group plc ('Ark' or the 'Company') today publishes its interim management statement for the period from 1 July 2009 to date, including an update of the Company's operations since the interim results announced on 26 August 2009.


Highlights

*
Further Cerepro® Phase III results presented by investigator on 22 October at the Society of Neuro-Oncologists' Conference in New Orleans
*
Commencement of contract manufacturing for Oy LX Therapies Ltd VEGF-C gene medicine programme
*
Positive feedback received from MHRA scientific advice meeting on EG013 for foetal growth restriction
*
Commencement of Phase I/IIa refractory angina trial with AIV Institute
*
Kerraglove® woundcare device for burns on the hand launched


Key Programmes

On 22 October further Cerepro® Phase III results were presented by one of the principal investigators for the study at the Society of Neuro-oncologists in New Orleans. There was considerable interest from medical professionals attending the conference with more than 200 attending Ark's satellite symposium. The EMEA's review of the Company's Marketing Authorisation Application has continued in the period and an opinion is still expected by the end of the year.


Late in the first half of the year we reported the recruitment of the first patient into the Trinam® US Phase III study. Following clearance of a technical manufacturing issue, efforts have been concentrated on site initiations and training of investigators in the procedure. With the recent regulatory clearance of the key opinion leader and Principal Investigator's site for patient recruitment and an increased number of sites now open, it is anticipated that enrolment will accelerate.


Recruitment of patients into the VitorTM Phase III pilot study in cachexia associated with cancer continues and, as stated at the time of the half-year results' announcement, despite a slower rate of recruitment than planned, an interim report on the study is expected before the end of the year.


Following the approval in late August from the Finnish National Agency for Medicines to start a Phase I/IIa trial in refractory angina (EG011) in collaboration with the AIV Institute in Finland, preparations for patient recruitment have progressed well and a number of patients are now in screening.


Woundcare

Sales of Ark's woundcare products have continued the period on period growth reported in the half-year results and, with Kerraglove® now launched, we look forward to maintaining this growth towards sustainable profitability for these products.



Intellectual Property Portfolio

We have continued to progress the realisation of value from our stroke patent in Europe with the clarification of the timetable for legal resolution. Pivotal hearings are now scheduled for next year. In the USA, no office actions are outstanding and we understand the grant of the ACE stroke patent is only delayed by the current general processing difficulties in the US Patent Office.


Manufacturing

Validation of the new manufacturing facility in Kuopio has proceeded according to plan. At the same time the initial phase of the manufacturing contract with Oy LX Therapies Ltd has been completed successfully and the Company is in late stage contract discussions with two further gene medicine companies which have approached Ark with a view to our undertaking their GMP manufacturing.


Cash

We reported in our half-year results' announcement on 26 August 2009 that the Company had £28.6m in cash and money market investments at 30 June 2009. Since that date cash consumption in the business has been in line with the Board's expectations as the Company continues to manage its resources and cost base carefully. The Board reviews detailed cash forecasts on a regular basis, which take into account a number of scenarios associated with product development and commercialisation, and remains satisfied with the current financial position of the Company. There have been no other significant changes in the position of the Company over the period since publication of the results for the six months ended 30 June 2009.


Nigel Parker, CEO of Ark, commented:


"The theme of our half-year results' announcement was 'Pioneering essential biomedicines'. Progress in the period since then has served to reinforce this statement not only with the positive response by clinicians to the latest published Cerepro® data but also in all other areas of our business. We continue to maintain our focus to advance the clinical development of products for serious unmet clinical need where DNA-based biologics offer the most logical treatment solution."

[BrauchGeld]

Wer gerne was riskiert sollte jetzt bei Ark einsteigen die meißten rechnen mit einem Kurssprung bis zu 400% sollte Ark die Zulassung erhalten wenn nicht sollte jedem klar sein das sich die Aktie eventuell halbiert .


http://www.epvantage.com/Universal/View.aspx?type=Story&id=1…



As far as binary events go they do not come much bigger, in relative terms, as the impending opinion of the European Committee for Advanced Therapies (CAT) over Ark Therapeutics’ application to approve Cerepro, a gene therapy product for the post-surgical treatment of high-grade malignant glioma, a particularly aggressive form of brain cancer.

Ark remains confident that a decision will be announced by the end of the year, and with the next meetings of CAT scheduled for November 12-13 and December 3-4, the company and its investors do not have long to wait. Given Cerepro’s novelty, it could become the first gene therapy to be approved in Europe, opinions on its chances of success are naturally divided. A positive opinion and Ark’s shares could literally take off and gain 400%, whereas a negative outcome could cause a 70% decline to trade close to current cash levels.

[BrauchGeld]

Antwort auf Beitrag Nr.: 38.437.108 von BrauchGeld am 23.11.09 13:26:16

Zwischen 3-4 Dezember wird über eine mögliche Zulassung entschieden !!

12:15 36.25p 400 £145 Buy
12:15 36.25p 400 £145 Buy
12:15 36.25p 1,000 £362 Buy
11:29 36.01p 264,444 £95,228 Buy

[Jano57]

http://www.investegate.co.uk/Article.aspx?id=200911241604340…

[BrauchGeld]

Antwort auf Beitrag Nr.: 38.447.389 von Jano57 am 24.11.09 18:50:39

L&G hat seinen Anteil um über 50000 st auf 8,62 Mio Aktien erhöht .

Es spricht einiges für eine Zulassung z.b. wurde Cerepro unter "Named-Patient-Programm" in Finnland und Frankreich bereits Zugelassen und auch stehen die Chancen gut weil Gehirnkrebs eine tödliche Krnakheit ist und es sehr wenige Therpiemöglichkeiten gibt .

[buy-out]

Antwort auf Beitrag Nr.: 38.448.784 von BrauchGeld am 24.11.09 21:43:18

Warum könnte die Entscheidung am 03. oder 04.12. fallen? Der Antrag
wurde doch beim CHMP-Gremium eingereicht und dieses tagt erst wieder
Mitte Dezember.

[Fruehrentner]

Warum kackt die Aktie im Vorfeld der möglichen Zulassung so ab?

Wissen da einige mehr?

Und warum haben wir nicht längst ein anderes, viel höheres Kursniveau erreicht,angesichts der Tatsache, dass das Studienziel der Phase-III erreicht wurde.

[buy-out]

Antwort auf Beitrag Nr.: 38.451.158 von Fruehrentner am 25.11.09 11:17:08

Ganz einfach, niemand weiß wann die Entscheidung getroffen wird.
Es könnte auch sein, dass die Zulassung erst im Januar erfolgt.
Ungewissheit ist für keine Aktie zuträglich. Sollte entsprechend
positiver Newsflow aufkommen, dann beschließen wir das Jahr bestimmt
auf einem neuen Jahreshoch. Das Abbröckeln des Kurses geschieht mit
einem relativ geringen Volumen, deshalb glaube ich nicht, dass hier
große Jungs (Insider) aussteigen.

Im Moment ist Geduld angesagt...

[Fruehrentner]

Antwort auf Beitrag Nr.: 38.451.853 von buy-out am 25.11.09 12:37:34

Cerepro® Phase III results presented by investigator on 22 October at the Society of Neuro-Oncologists' Conference in New Orleans


Dennoch, warum gabs keinen Kurssprung nach den positiven P-III Ergebnissen Ende Oktober?

[BrauchGeld]

Antwort auf Beitrag Nr.: 38.451.853 von buy-out am 25.11.09 12:37:34

@ buy-out

Der CEO und einige Analysten haben erst vor ein paar tagen erwähnt das eine Entscheidung noch vor Jahresende erwartet wird.

Die schlechte Performance hat glaube ich eher mit "Tax-Loos-Selling" zu tun ist um diese Zeit üblich :
http://books.google.de/books?id=F0tRr3U66GgC&pg=PA559&lpg=PA…


@ Fruehrentner

Es gab einen kleinen Kurssprung über 50p aber am nächsten Tag gings wieder abwärts ..

[Fruehrentner]

Antwort auf Beitrag Nr.: 38.452.472 von BrauchGeld am 25.11.09 13:54:06

Es gab einen kleinen Kurssprung über 50p aber am nächsten Tag gings wieder abwärts ...


Ja und genau das verstehe ich nicht, warum es danach wieder abgebröckelt ist. Gibt es vielleicht doch noch irgendwelche Bedenken gegenüber Cerepro®?

Wie hoch werden eigentlich die peal sales von Cerepro® erwartet und für wann werden diese erwartet?

[buy-out]

Das war heute ein beeindruckendes Volumen. Zwar wieder im Minus
geschlossen, aber um die 32p wurde alles aufgefangen.

Könnte der Boden gewesen sein...

[buy-out]

Wieder mal über 200.000 Stück bei 32,5 p im Bid. Da wird gesammelt...

[Fruehrentner]

[BrauchGeld]

Es gibt nichts was gegen Cerepro spricht die Daten bisher sind alle Positiv gewesen .

The clinical data presented so far for Cerepro, from four clinical trials in phases I, IIa, IIb and III, have mainly been encouraging although many commentators remain wary and some even angry that the company has not released the full details of the phase III trials.


Cerepro könnte (falls das OK kommt) sich langfristig zu einem Blockbuster entwickeln der einzige konkurrent ist Temodar von Merck dessen Patent in 2014 abläuft !

Growth driver

The huge disconnect between Ark’s market value and the potential value of Cerepro alone also highlights the significant upside should approval be granted in Europe, and even the US within the next couple of years.

Given the niche market for Cerepro, within Europe a sales force of just 20-30 reps could successfully commercialise the product. Analysts currently expect a launch by the middle of next year and for worldwide sales to ultimately reach $266m by 2014. This would value the product at over $1bn according to EvaluatePharma’s NPV Analyzer.

As a benchmark, Merck & Co’s Temodar is currently the gold standard treatment for brain cancer and global sales last year exceeded $1bn. Temodar’s patent protection will expire in 2014.

[Fruehrentner]

Antwort auf Beitrag Nr.: 38.460.897 von BrauchGeld am 26.11.09 13:49:58

Umso mehr verstehe ich deshalb nicht, warum der Kurs nicht längst angesprungen ist.

Die Zulassung scheint ja demzufolge fast nur noch eine Formsache zu sein.

[Fruehrentner]

Antwort auf Beitrag Nr.: 38.460.897 von BrauchGeld am 26.11.09 13:49:58

Übrigens, die Patent- bzw. SPC-Laufzeit von Temodar ist bereits abgelaufen.

Da die Datenschutzfrist für Temodar bis Januar 2009 lief, kommen die ersten Generika ca. 1 Jahr später, also Anfang 2010.

[Fruehrentner]

Antwort auf Beitrag Nr.: 38.461.583 von Fruehrentner am 26.11.09 15:22:31

Diese Info bezieht sich auf Europa.

In USA kann es anders aussehen!

[BrauchGeld]

Über 8% gehts heute rauf ....Nur noch wenige tage bis zur Entscheidung und Phase 3 Daten stehen auch noch diesen Monat an !

[Bombenleger]

RNS Number : 3816E
Ark Therapeutics Group PLC
18 December 2009



European Medicines Agency recommendation on Cerepro®




Ark to appeal EMEA opinion on Cerepro® for malignant brain cancer







London, UK, 18 December 2009 - Ark Therapeutics Group plc (AKT: LSE) ("Ark" or "the Company"), announces that it has received notice from the European Medicines Agency (EMEA) that the European Committee for Medicinal Products for Human Use (CHMP) has adopted a negative opinion for Ark's marketing authorization application (MAA) for Cerepro®, Ark's novel gene-based therapy for operable malignant glioma (brain cancer). The filing was based on results from the "904" phase III trial and Ark intends to provide data to support re-examination through the standard appeal procedure.




EMEA opinion

The MAA application for Cerepro® was filed in November 2008 and has undergone formal review via the centralised procedure.




The main underlying objection from the regulator which had not been resolved concerns specifically whether or not patients treated with Cerepro® might for some reason, have been left longer by surgeons prior to re-intervention than those who did not receive Cerepro®. As time to re-intervention is the main efficacy measure in the primary endpoint, the assessors determined that they could not recommend approval based on the data presented by Ark so far. The CHMP has thus adopted a negative opinion as Ark had not at that point in time provided trial evidence beyond doubt that Cerepro® has demonstrated adequate efficacy. Significantly, all issues relating to the other elements of the regulatory package, notably the key Chemistry and Manufacturing Controls (CMC), Pre-clinical and Environmental Dossiers were cleared by the assessors and were thus deemed 'approvable'.




Cerepro® has Orphan Drug Status in both Europe and the USA and is manufactured by Ark in Finland.




Professor Seppo Ylä-Herttuala, Consultant Director of Molecular Medicine at Ark commented: "Cerepro® has produced good safety and efficacy data in a difficult to treat disease where new treatments are much needed. It has the potential to be the first gene-based medicine to be approved and, as such, is navigating uncharted waters from a regulatory perspective. It is perhaps unsurprising therefore that the approval process is taking longer than patients would hope for, but it is significant that the adenovirus platform technology has no outstanding issues and I believe it is a matter of time before the product gains approval."




Nigel Parker, CEO at Ark, added: "We are naturally very disappointed with this opinion. We have a considerable body of evidence from the study which we believe will address the main objection with respect to re-intervention. We are planning to file for re-assessment in a matter of days and expect the appeal process to take about four months. Despite this setback, we are pleased that Ark's underlying adenovirus platform has cleared all other barriers to a full approval. This is a major milestone both for Ark and the industry and gives us the confidence to progress development of our complete adenovirus portfolio."



Re-intervention

Study 904 was an open label study and as with any open study where it is not ethical to administer a placebo, there is always the potential for bias. The regulator's main objection was that the primary endpoint re-intervention decision may have contained elements of physician subjectivity which might have favoured the Cerepro® treated patients. Ark had provided, as part of the last review stage, data which showed that recurrent tumour volumes at the pre-reintervention MRI scan and the time elapsed thereafter to actual re-intervention were similar in active and control groups. The data indicated no bias on these important physical re-intervention related parameters. The precise subjectivity concern was discussed during questions in the last presentation by Ark to the regulator and as yet remains unresolved.




Ark believes it has substantial data from the main trial with which to address this issue. The trial endpoints and analyses used in Study 904 reflect the latest published recommendations from international expert working groups reviewing glioma trial design.




Whilst overall survival was consistently in Cerepro®'s favour in Study 904, with hazard ratios showing a 16%-29% benefit from Cerepro®, these data were not considered adequate as improvements were not statistically significant across all study analyses. On this basis, the regulator determined the Phase III trial has, so far, failed to prove efficacy and the range of positive analyses, including MGMT status results, may have been chance findings.




Next steps

Ark expects to close the financial year with over £20m of cash. While Ark remains confident that it has strong data to support the re-examination in early 2010, the delay which the appeal process introduces means that the Company believes that it is prudent to undertake actions now to reduce its cost base. Ark's wound care business has continued to show growth in excess of 70% year to date and is approaching sustainable profitability. In addition to the contract already announced with Oy Lx Therapies Ltd, Ark has recently signed a further agreement to commence manufacturing process development for a second company and will continue to respond to enquiries in its specific areas of expertise.




For further information:




Ark Therapeutics Group plc

Dr Nigel Parker, CEO

Martyn Williams, CFO
Tel: [phone]






Financial Dynamics

Ben Atwell

Susan Quigley
Tel: [phone]








Notes to Editors




Malignant glioma

Malignant glioma is a devastating and fatal form of brain tumour that is usually confined to the brain. The current standard therapy involves surgically removing the solid tumour mass (when possible) and initiating radiotherapy and/or chemotherapy. Even with the latest approved treatments, many patients die within one year of diagnosis, with average survival being about fourteen months. Little therapeutic progress has been made in recent years and the prognosis for malignant glioma patients is poor. A high unmet clinical need exists for new treatments that prolong life in this devastating disease. There are approximately 16,000 cases of malignant glioma in the EU which are operable.




Cerepro®

Cerepro® is an adenoviral mediated gene-based medicine (ad.HSV tk) given by multiple injections into the healthy brain tissue of patients following surgical removal of the solid tumour mass. In the following days, ganciclovir, is given intravenously. Once treated, healthy brain cells surrounding the site where the tumour was removed express the enzyme thymidine kinase. This converts the ganciclovir to a substance which specifically kills dividing cells. The healthy neurones surrounding the tumour in the brain are non-dividing and are therefore not susceptible to this substance. In this way Cerepro® harnesses healthy brain cells to help prevent a new tumour from growing.




About 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®, three further lead pharmaceutical products in late stage clinical development: Cerepro®, Vitor™, and Trinam® and two in Phase I/IIa trials, EG011 and EG016 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 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, as 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.





This information is provided by RNS
The company news service from the London Stock Exchange



RNS news service provided by Hemscott Group Limited.

[Bombenleger]

Wie schätzt Ihr die weitere Entwicklung ein?

[Fruehrentner]

Ark Therapeutics Treats First Patient In Phase I/IIa Refractory Angina Trial

Published: 28-Jan-2010

Ark Therapeutics (Ark) has enrolled and treated the first patient 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).

The company reported that 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.

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 Yla-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 provide initial efficacy data.

Earlier in June 2008, in the 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.