Ark Therapeutics - 500 Beiträge pro Seite

[BrauchGeld]

Hallo

Ein wirklich tolles Unternehmen das mir auf anhieb gut gefallen hat.
Die haben bereits ein produkt(Kerraboot)auf den markt und weitere in fortgeschrittenen testphasen.
Ark ist mit rund 113mio pfund bewertet und haben mit knapp 50mio pfund reichlich geld auf der Bank.
Ist auch in Deutschland gelistet aber noch 0 umsatz wird sich aber bestimmt bald ändern.

Produkte:



Cerepro™ (EG009) - a treatment for malignant brain tumours – Phase IIb completed



Vitor™ (EG006) - a treatment for cancer related muscle wasting (cachexia) in Phase III


Trinam® (EG004) - a product to prevent blood vessels blocking after vascular graft surgery, in Phase II


Kerraboot® (EG008) - a dressing device for the treatment of leg ulcers, launched in the UK and approved for marketing in the US



EG005 - a treatment for the fat metabolism problem (lipodystrophy syndrome) associated with the most common therapy for HIV positive patients, in Phase II



EG001 - a bio-degradable device placed around the outside of blood vessels for the localised delivery of therapeutic agents, currently in development as part of the Trinam® project



EG010 - Ox-LDL diagnostic kit in CE Mark Development

www.arktherapeutics.com

[BrauchGeld]

Die Zahlen von 10.März

http://moneyextra.uk-wire.com/cgi-bin/articles/2005031007002…

Ark Therapeutics Group PLC
10 March 2005

Ark Therapeutics Group plc

Preliminary results for the year ended 31 December 2004

A YEAR OF SUBSTANTIAL PROGRESS AND ACHIEVEMENT

London, UK, 10 March 2005 - Ark Therapeutics Group plc today announces its
preliminary results for the year ended 31 December 2004.

HIGHLIGHTS

• Listing on London Stock Exchange raised £55 million
• Kerraboot(R) received UK Drug Tariff Listing at a reimbursement price
of £14
• Kerraboot(R) UK sales showed steady upward trend in first six months
of primary care promotion
• Second safety and efficacy study for Cerepro(TM) showed mean patient
survival time increased by 80% in malignant glioma
• Trinam(R) received Orphan Drug Designation in the EU
• First international out-licensing deal signed with Teva Medical for
Kerraboot(R) in Israel
• EG005 Phase II in lipodystrophy completed enrolment
• Finnish manufacturing facility received Good Manufacturing Practice
certification (cGMP)
• Named patient supplies of Vitor(TM) made available at request of
investigators for patients completing Phase III study
• Cash of £47 million at 31 December 2004

POST YEAR-END EVENTS

• Patent for Trinam(R) granted by European Patent Office


Dr Nigel Parker, CEO of Ark, commented:

`We made substantial progress in all aspects of our business in 2004 and
demonstrated that we are delivering on key milestones during our first year as a
publicly quoted company. Our progress to date supports our belief that we are
well placed to achieve our goal of becoming one of a successful new breed of
diversified healthcare companies servicing areas of high clinical need in
hospital and specialist medicine.`

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
Lucy Briggs


Notes to Editors

Ark Therapeutics Group plc

Ark is a specialist healthcare group (the `Group`) with one marketed product and
three further lead products in late stage clinical development. Capitalising on
over ten years of research in vascular biology and gene-based medicine, Ark has
a balanced product portfolio targeted at specific unmet clinical needs within
vascular disease and cancer. These are large and growing markets, where
opportunities exist for effective new products to generate significant revenues.

Ark`s 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 Company`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 continue to play leading roles in the Company`s research
and development programmes.

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 (other than pursuant to the Listing
Rules of the UKLA) 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, prospective investors are cautioned not to rely on any
forward-looking statement.



Chairman`s and Chief Executive`s review

2004 - a year of substantial progress and achievement

We are very pleased to report that 2004 was a most successful year for the Ark
Group. In the first quarter, we completed our initial public offering on the
London Stock Exchange, raising £55 million and we have gone on to achieve some
very notable milestones during the rest of the year. For example, we brought
our first product, Kerraboot(R), to the primary care market in the UK and
completed our first international out-licensing deal for that product. We
achieved certification of our biologics manufacturing facility in Finland, as
well as progressing all our other lead products in later stage clinical
development. We were also pleased to introduce named patient supplies in
response to investigator requests in our Vitor(TM) Phase III study (cancer-
related cachexia) and our EG005 Phase II programme (lipodystrophy syndrome), to
allow patients completing those trials to continue on active therapy. Our
follow-on clinical portfolio has continued to show good progress, as have our
research teams working on the earlier stage baculoviral and Scavidin(R)
programmes.

Overall, we have made substantial progress in all aspects of our business and
finished the year with strong cash reserves (£47 million), having demonstrated
that we are delivering on key milestones in this, our first year as a public
company. The results for the year reinforce our belief that we are well placed
to achieve our goal of becoming one of the successful new breed of diversified
healthcare companies servicing areas of high clinical need in hospital and
specialist medicine.

Kerraboot(R) - a novel device for the management of leg and foot ulcers

Launched in the UK and international commercialisation commenced

Early in the year, we were encouraged to see initial orders being placed
directly by hospitals through PASA, the NHS Purchasing and Supply Agency. UK
Drug Tariff Listing, enabling the product to be prescribed in primary care, was
achieved in May at a price above analysts` expectations, and in June our
newly-recruited sales force commenced selling into hospitals and primary care.
Since then, UK sales and market share have shown a steady upward trend, despite
some anticipated seasonal slowing over the Christmas holiday period. Sales
doubled between the third and fourth quarter.

We also completed a primary care-based post-marketing comparative study with
results showing that the product met its primary endpoint of healthcare worker
and patient acceptability, with the significant additional finding that the
overall healing profile of ulcers was better with Kerraboot(R) than with the
standard care dressing. Company sales representatives report a high level of
interest in this novel product with clinical successes in all types of ulcers,
including some of the most difficult cases.

We achieved our goal of all three of the main UK wholesalers stocking the
product by the end of 2004. We were also pleased to report that following the
2004 tendering initiative in the UK, Kerraboot(R) was selected for inclusion in
the new NHS Framework Agreement (Framework Agreements, established by the NHS
Purchasing and Supply Agency (PASA) which acts for the NHS Logistics Authority,
are aimed at reducing costs in high expenditure categories in the NHS.) for the
provision of Advanced Wound Care Products to hospitals throughout England
without price modification.

In response to market feedback, the Company plans to introduce three new
versions of the product during 2005: an extra large size, a non-see through boot
and a super-absorbent version for high exudate cases. Internationally, we will
build on our first out-licensing success, the agreement with Teva for Israel,
and negotiations are progressing well with potential licensees in other major
markets. We are excited by the sales potential and value to the Company of this
innovative product.

Cerepro(TM) for operable malignant brain cancer

Moving forward with this pioneering treatment

We presented the full results of the second safety and efficacy study of
Cerepro(TM) in malignant glioma in June. Results showed an almost doubling of
mean survival time, confirming the findings of the previous Phase II safety and
efficacy study. In the third quarter we completed the `top up` toxicology
study agreed during our ongoing discussions with the EMEA, enabling us to update
the pre-clinical dossier. Other milestones included approvals for the further
development of Cerepro(TM) from both national agency and gene therapy advisory
committees in seven of the nine countries participating in the next study. This
is enhancing confidence in Ark`s handling of the complex regulatory pathway for
the development of gene-based medicines.

Certification in November of our manufacturing facility by the Finnish National
Agency of Medicines was a very significant achievement. Amongst other things,
this allows us to produce clinical supplies of Cerepro(TM) for the corroborative
study and to start finalising the chemistry and manufacturing dossier for the
EMEA. This is required as part of our expected submission in the first half of
2005 for Cerepro(TM) to be considered for approval under exceptional
circumstances in Europe.

With the progress made in 2004, we believe that Cerepro(TM) remains on track to
become one of the world`s first commercially available gene-based medicines.

Vitor(TM) for cachexia of cancer

Interesting new mode of action data: enrolment in Phase III trial nears
completion

Enrolment into the Phase III study accelerated markedly in the second half of
the year after we opened further centres in Eastern Europe. Completion of
enrolment is expected around the end of this quarter. The Drug Safety
Monitoring Board continued to advise that no side effects had been reported that
might give rise to concern as to the safety of the product.

Furthermore, the research elucidating the way Vitor(TM) works in preventing muscle
cell breakdown in cachexia received recognition at the 2004 Multi-National
Association of Supportive Care in Cancer (MASCC) conference in the USA, where
our research collaborators (Professor Tisdale and his team at Aston University,
Birmingham) won one of the Investigator of the Year Awards.

The Company also announced in December its agreement to supply Vitor(TM) to named
patients at the request of Canadian, US and UK investigators, so that patients
completing the trial could continue on active therapy.

Trinam(R) treatment to prevent haemodialysis access surgery complications

`First time into man` approval and first patients successfully treated in Phase
II study

In the first half of 2004, Trinam(R) achieved a milestone Ethics Committee
approval in the US, clearing the `first-time into man` hurdle and, consequently,
we were able to open the Phase II study for patient recruitment. The first
treatment of a patient with Trinam(R) took place in May and at the end of 2004
five patients had been treated at Duke University, with four going on to
successful haemodialysis and the other having a successful kidney transplant.
Further centres have now been opened in Miami, where the first patient is
awaiting treatment and Norfolk, Virginia where screening has commenced. To date
no safety issues of concern have arisen. The Company expects to report initial
results around the end of 2005.

Trinam(R) received EU Orphan Medicinal Product Designation in June, in addition
to the US Orphan Designation previously granted and we announced recently that
the European Patent Office has granted the patent.

FOLLOW ON PRODUCTS

EG005 - full enrolment of the EG005 Phase II study in HIV positive-related
lipodystrophy syndrome occurred in November and we remain encouraged that the
majority of patients completing the blinded three month placebo controlled phase
of the study elected to go into the one year open label extension phase. Almost
all patients completing the one-year extension have requested to continue
treatment on a named-patient basis and we were pleased to respond to those
requests and make the product available. If the Phase II results expected in
the first half of 2005 are favourable, the Company intends to move the product
into its lead portfolio.

EG010 is a diagnostic test measuring oxidised low density lipoproteins present
in blood as a marker to assess a patient`s risk of having a heart attack.
Trials to date have shown high prediction levels. The product is currently
undergoing stability testing and is likely to be one of the first tests to
comply with the latest European `equivocal zone` regulations, having its own
internal controls to increase its accuracy. CE-marking is expected in the first
half of 2005.

Pre-clinical

The business model employed by Ark for sourcing pre-clinical candidates,
combines academia and industry in a way which is proving highly cost-effective.
We have made good progress with both our versatile baculoviral vector and
functional genomics programmes, as well as with Scavidin(R), our targeted drug
delivery platform. We also have interesting early evidence that our Neuropilin
1 antagonist programme inhibits migration of tumour cells. Given the results we
have achieved to date, we intend to continue to employ this successful and
cost-effective approach to primary research both to advance our existing
programmes and to make new discoveries.

Manufacturing - on track

During the first half of 2004 we completed the structural work to upgrade our
Finnish manufacturing facility to Phase III/commercial supply. Validation
continued throughout the second half of 2004 and we achieved our principal goal
of certification of the facility in November. The Company intends to continue
to invest in its manufacturing capabilities for CereproTM and Trinam(R)
production.

Board and management - strengthening

David Prince, the former CFO of Cable and Wireless, joined the Board in May as a
Non-Executive director and took up the position of Chairman of the Audit
Committee. David is an experienced Director who, with his strong track record
in financial management, is making a valuable contribution to the business. The
Company is currently interviewing for an additional Non-Executive Director with
international biotech/pharmaceutical experience.

In April, Nick Plummer joined us from the law firm Ashurst as Legal Counsel and
Company Secretary, further strengthening our senior team.

Simultaneous with the IPO, Professor John Martin and Dr Kalevi Kurkijarvi
resigned from our Board as part of the restructuring in connection with becoming
a public company. John Martin remains deeply involved in the business as Chief
Scientific Officer and a member of the executive team. Both gave generously of
their time and on behalf of the Board and our shareholders we thank them for
their significant Board contributions to our success to date.

Strengthened finances

Following the Company`s IPO in March, cash and liquid resources at 31 December
2004 totalled £47.3 million (2003: £9.2 million), a level of funding which will
enable the Group to progress with confidence its lead products through the final
stages of development and support the continued roll-out of Kerraboot(R).

Operating expenses in the year were £16.1 million compared with £9.2 million in
2003, principally as a result of the progression of our lead products though the
clinical development process, together with increased investment in the Group`s
advanced biologics manufacturing facilities and in the Kerraboot(R) sales and
marketing structure.

Research and development expenditure in 2004 rose to £9.1 million from £5.4
million in 2003, reflecting the progress made in the Vitor(TM) Phase III study,
the commencement of the Trinam(R) Phase II study and initiation costs for the
Cerepro(TM) corroborative study. Increased investment in the Finnish
manufacturing facility was also made in the year, culminating in certification
by the Finnish National Agency for Medicines.

Sales and marketing costs at £1.3 million (2003: £0.3 million) related to the UK
launch of Kerraboot(R), including recruitment and ongoing costs of the sales
force and marketing expenses.

Administrative expenses in the period rose to £5.7 million from £3.6 million,
reflecting the general increase in Group activities and the additional
managerial and administrative support for the growing research and development
and sales activities.

Prospects

The year ahead of us will be an exciting one. We expect to build on the
significant progress we have made since the IPO as we continue the transition
from a company focused on research and development to a commercial,
revenue-generating business. In particular, we intend to continue to develop
the UK sales and international commercialisation of Kerraboot(R) and we expect
to report whether or not the EMEA is prepared to consider Cerepro(TM) as a
candidate for approval under exceptional circumstances. We anticipate reaching
key clinical milestones in all our lead products.

All those involved in the Company, both in the UK and Finland, have put in a
tremendous effort over the last year. As a result, we have achieved some of the
most significant milestones in the history of the Company, whilst at the same
time Ark has made the transition to a public company. We are most grateful to
all of our staff for their dedication and accomplishments.

Much has also been achieved in furthering the strategic shift towards effective
product exploitation. This, combined with Ark`s significant strength in research
and development, underpins our confidence in the Company`s potential in 2005 and
beyond.

[BrauchGeld]

Aktuell steht Ark bei 97 pence nächste woche fällt hoffentlich die 100er marke .

Ark Therapeutics Group: Outperform

Die Analysten der Credit Suisse First Boston stufen im Rahmen ihres am 13. Januar veröffentlichten Berichts "Biotechnology and Biopharmaceuticals Sector Overview" die Aktie des britischen Biotech- und Pharmaunternehmens Ark Therapeutics Group (Nachrichten) mit "Outerpform" ein. Das Kursziel beträgt 144 Pence.

Der größte Teil des Unternehmenswerts basiere aus Sicht der Analysten auf dem führenden Medikament zur Behandlung von Gehirntumoren, Cerepro, und dem Wundheilungspräparat Kerraboot. Der kurzfristige Fokus dürfte weiterhin bei Cerepro bleiben, das eine neuartige gentechnische Therapie bei operierbaren Gehirntumoren darstelle. Nach der EMEA-Zulassung und der Errichtung einer Produktionsstätte im November werde das Produkt im ersten Halbjahr 2005 in die Phase III eintreten.

[BrauchGeld]

Hi

Super gleich heute schon die 100 pence geknackt hätte ich nicht erwartet aktuell 104,5p oder über 7% kursplus.
Weitere Kursgewinne sind zu erwarten da immer noch niedrig bewertet.

Go Ark Go Ark Go Ark

[BrauchGeld]

Ark Granted Patent in Europe for Trinam(R)


Ark Therapeutics Group plc today announces that
it has been issued with a patent by the European Patent Office for Trinam(R),
its novel therapy to prevent blood vessels blocking after vascular graft access
surgery. Subject to the payment of renewal fees, this patent can be maintained
until at least 2016.

Trinam(R), which is one of Ark`s four lead products, is a combination of a
Vascular Endothelial Growth Factor (VEGF) gene in an adenoviral vector and Ark`s
biodegradable collagen collar local delivery device (EG001). The initial target
market for Trinam(R) is haemodialysis access graft surgery, a treatment for
kidney failure patients where a plastic tube is grafted between blood vessels in
the forearm to enable regular blood filtration. At the end of the access graft
surgery procedure, the EG001 delivery device is fitted around the outside of the
vein where it had been joined to the access graft. The VEGF gene in solution is
then injected into the reservoir formed between the delivery device and the
blood vessel, from where it passes into the blood vessel wall, transfecting the
smooth muscles cells in the wall - a process known as adventitial transfection.
This unique method of administration allows Trinam(R) to be localised to the
target site where the therapy is needed.

In the US and Europe, there are an estimated 150,000 cases a year where
Trinam(R) might be used. In patients with haemodialysis access grafts, up to
60% of the grafts block within a year of being inserted, and repeat surgery
shows more rapid failure rates. Trinam(R) is expected to extend the useful
life of access grafts and reduce costly repeat procedures. There are currently
no approved drug therapies to reduce the failure rates of access graft
procedures for haemodialysis patients.

Preclinical studies have demonstrated a significant effect in preventing intimal
hyperplasia and successful adventitial gene transfer. Trinam(R) is currently
in Phase II clinical trials in the USA. The Phase II ascending dose study in up
to 20 patients is designed to examine the efficacy and safety of Trinam(R) in
patients undergoing haemodialysis access graft surgery.

Dr Alan Boyd, Research and Development Director of Ark, commented; `Using
Trinam(R) to prevent the problem of access graft blockage is a novel concept
that was developed through a collaboration between our research groups in the UK
and Finland. As such, the granting of this patent is an important validation of
our research ideas and science.`

[BrauchGeld]

Super wie die aktie steigt aktuell 7,5% plus auf 114,50p
und das ohne nachrichten.

Go Baby

[BrauchGeld]

Schliesst auf tageshoch bei 118,50p über 11% plus.

21.05.2005
Director Shareholding

http://moneyextra.uk-wire.com/cgi-bin/articles/2005032116291…

http://moneyextra.uk-wire.com/cgi-bin/articles/2005032116215…

[BrauchGeld]

Hi

Ark schliesst wieder im plus 119,50p.
Tagesrange:116-122

[BrauchGeld]

Hi

Ark steigt und steigt aktuell 124,50p wunderbar.

News

Ark Therapeutics Group plc

Regulatory Update on Cerepro(TM) and Vitor(TM)

23 March 2005: Ark Therapeutics Group plc (`Ark` or the `Company`) today
announces regulatory progress for its two lead products, Cerepro(TM) and
Vitor(TM).

EMEA appoints Rapporteurs for Cerepro(TM)

Ark announces that as part of ongoing discussions with the EMEA concerning its
product Cerepro(TM), a novel therapy for operable malignant glioma, the EMEA has
formally appointed a Rapporteur and Co-Rapporteur for the product. The role of
the Rapporteurs is to manage the application for marketing authorisation, which
Ark intends to file under the exceptional circumstances provisions, through the
centralised regulatory process. Ark further announces that it has now met with
both the Rapporteur and the Co-Rapporteur together with their country
representatives and both have indicated their willingness to perform this
function.

Ark has performed three clinical studies to date with Cerepro(TM), a Phase I
study establishing safety and posology (dosing and method of administration) and
two safety and efficacy studies, both showing Cerepro(TM) produced an average
extension of 7 months` survival in a disease where most patients will live for
around eight months. Cerepro(TM) has Orphan Drug Status in Europe and the USA
and is manufactured by Ark in Finland.

Dr Alan Boyd, Director of Research & Development at Ark, said, `We are pleased
to have cleared this next step with the EMEA. The results observed in the
trials for Cerepro(TM) to date represent a large clinical benefit to patients in
this devastating disease where new effective treatments are urgently needed. We
are now continuing with the development and manufacturing work necessary for
filing.`

Vitor(TM) submission via Decentralised Procedure advised as appropriate
regulatory route

Ark also announces that it has attended a pre-submission meeting with the
Medicines and Healthcare products Regulatory Agency (MHRA) to discuss the
regulatory position for Vitor(TM). The Agency advised during the meeting that
should the Phase III study results in cancer cachexia, due in H2 2005, show
relevant and significant clinical benefits in the treatment`s favour, with an
acceptable safety profile, then submission via the new decentralised procedure,
which comes into effect later this year, would be appropriate.

Vitor(TM) is a small molecule in Phase III development in the USA, Canada and
Europe. Ark expects to complete enrolment in the study in the next few weeks,
giving a target date for initial results to be available of Q3 2005. Vitor(TM)
works by enhancing mitochondrial activity and both reducing protein breakdown
and enhancing protein synthesis in muscle cells via the ubiquitin-proteasome
pathway.

Dr Alan Boyd, Director of Research and Development at Ark, said: `Given the
status of the Phase III trial with Vitor(TM), now was the appropriate time to
start discussions with the Regulatory Authorities. We are pleased to have
established the appropriate regulatory pathway for the product and that the
route is in line with our internal plans.`

[BrauchGeld]

Hallo

Ark Therapeutics Group PLC
1 April 2005



Ark Grants Licence to Boehringer Ingelheim
for Access to Key Technology



1 April 2005 - Ark Therapeutics Group plc today announces that it has signed an
agreement with the German pharmaceutical company, Boehringer Ingelheim
International GmbH, granting Boehringer Ingelheim exclusive rights to Ark`s
intellectual property in relation to certain Boehringer Ingelheim therapies
affecting the renin-angiotensin system. Although detailed financial terms of
the agreement were not disclosed, Ark receives a material upfront payment on
signing and several multi million Euro payments expected over the next few years
on the achievement of certain pre-defined milestones. In addition, Ark will
receive royalties on sales of a Boehringer Ingelheim product for the treatment
of patients in certain cardiovascular related indication areas for which Ark is
able to secure and maintain a valid patent.


There is increasing interest in the use of drugs which affect the
renin-angiotensin system (a natural hormone cascade) in treating vascular
related conditions. Ongoing clinical studies such as Boehringer Ingelheim`s
PROFESS(R) and ONTARGET(TM)/ TRANSCEND trial program (1) are being performed in
order to accumulate clinical evidence about their effectiveness in reducing the
incidence of such conditions. Market research data suggest the sales of these
compounds is likely to increase significantly in the future as physicians switch
to newer therapies in this growing market, driven by population aging and an
increasing prevalence of vascular disease-related events.


Ark`s intellectual property encompasses a fundamental discovery that chemicals
within the body`s renin-angiotensin system play a significant role in
determining the ability of mitochondria (2) to generate the energy for cells to
survive. The scope of Ark`s intellectual property covers the use of all agents
which affect the renin-angiotensin system for the treatment of complex
vascular-related and metabolic disorders.


Dr Nigel Parker, Chief Executive of Ark Therapeutics, commented: `The novel
work of Ark`s scientists and collaborators has contributed to a wider
understanding of the potential utility of this class of drugs in a range of
disorders. Whilst Boehringer Ingelheim is the first to acknowledge the
importance of Ark`s discoveries in these areas, Ark may grant further licences
in the future to other companies.`


Paul Higham, Director of Commercial Development at Ark, commented: `We are
pleased to have finalised this agreement with Boehringer Ingelheim in this very
significant indication. We look forward to what we all hope will be the
successful completion of their clinical studies and to the registration of
Boehringer Ingelheim`s products in these important areas of unmet need.`




1.PROFESS(R): PReventiOn regimen For Effectively avoiding Second Stroke

ONTARGET(TM): ONgoing Telmisartan Alone and in combination with Ramipril Global
Endpoint Trial

TRANSCEND: Telmisartan Randomized AssessmeNt Study in aCE iNtolerant subjects
with cardiovascular Disease



2. Mitochondria are cellular substructures considered to be the power station of
the cell




Ark Therapeutics Group plc [phone]
Dr Nigel Parker, CEO
Paul Higham Director of Commercial Development





Financial Dynamics [phone]
David Yates
Lucy Briggs




Ark Therapeutics Group plc


Ark is an emerging specialist healthcare group (the `Group`) with one marketed
product and four further lead products in late stage clinical development.
Capitalising on over ten years of research in vascular biology and gene-based
medicine, Ark has a balanced portfolio of proprietary healthcare products
targeted at specific unmet clinical needs predominantly with within vascular
disease and cancer. These are large and growing markets, where opportunities
exist for effective new products to generate significant revenues.


Ark`s products are sourced from related but largely non-dependent technologies
within the Group and have been selected to enable Ark to take each product
through development and to benefit from Orphan Drug Status and/or Fast Track
Designation, as appropriate. The Group generally retains ownership of its
product candidates throughout clinical development and intends to conduct it`s
own sales and marketing in certain territories as well as securing marketing
partners in others.


The Group has operations in London, UK and Kuopio, Finland.


Ark`s shares are traded on the London Stock Exchange (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, prospective investors are
cautioned not to rely on any forward-looking statement.



Boehringer Ingelheim


The Boehringer Ingelheim group is one of the world`s 20 leading pharmaceutical
companies. Headquartered in Ingelheim, Germany, it operates globally with 152
affiliates in 45 countries and more than 34,000 employees. Since it was founded
in 1885, the family-owned company has been committed to researching, developing,
manufacturing and marketing novel products of high therapeutic value for human
and veterinary medicine.

In 2003, Boehringer Ingelheim posted net sales of 7.4 billion euro while
spending more than one fifth of net sales in its largest business segment
Prescription Medicines on research and development.


For more information please visit
www.boehringer-ingelheim.com

[BrauchGeld]

Hi

Ark Therapeutics Group PLC
07 April 2005



ARK THERAPEUTICS PLC STRENGHTENS R&D MANAGEMENT TEAM

APPOINTMENT OF Dr DAVID ECKLAND


7 April 2005, London UK: Ark Therapeutics Group plc (`Ark` or the `Company`),
the emerging healthcare group, today announces the appointment of Dr David
Eckland as Head of Research and Drug development. Dr Eckland`s appointment
follows Dr Alan Boyd`s decision to move to a part-time role in Ark Therapeutics
focusing on the strategic regulatory and drug approvals, with immediate effect.

David has spent the last 8 years at Takeda Europe, a new European development
centre in London for Takeda, one of Japan`s largest pharmaceutical companies.
He was until recently Managing Director of Takeda Europe R&D Centre, a position
he took up in 2002. In this role, David was responsible for over 70 staff, and
the clinical and regulatory development of approximately 15 products. Prior to
this David was European Development Director for Takeda and created a Clinical
Development Organisation to support the regulatory process in Europe.

Before joining Takeda, David spent 7 years at GlaxoWellcome holding the
positions of International Director of Metabolic Diseases Clinical Research, and
Head of the Clinical Pharmacology Unit and Head of Department of Clinical
Pharmaco Dynamics. His work focused on both the pre-clinical, clinical science
and the regulatory orientated clinical trials. David holds a PhD in
Endocrinology and, as a physician, specialised in Endocrinology, Diabetes and
General Internal Medicine.

Commenting on his appointment, Dr Nigel Parker, CEO of Ark, said: `I am
delighted to welcome David and that Alan has decided to retain a part-time role
at Ark Therapeutics. As our lead products progress through late stage trials
and the regulatory processes, the recruitment of world class R&D management is
key to the Company`s continued success. David`s extensive medical and R&D
experience will be invaluable to Ark as we further progress our pipeline. Alan
will continue to provide key input for the R&D department on an ongoing basis.`



ENDS



Enquiries:

Ark Therapeutics Tel: [phone]
Nigel Parker, CEO
Financial Dynamics Tel: [phone]
Lucy Briggs



Ark Therapeutics Group plc

Ark is an emerging specialist healthcare group (the `Group`) with one marketed
product and four further lead products in late stage clinical development.
Capitalising on over ten years of research in vascular biology and gene-based
medicine, Ark has a balanced portfolio of proprietary healthcare products
targeted at specific unmet clinical needs predominantly with within vascular
disease and cancer. These are large and growing markets, where opportunities
exist for effective new products to generate significant revenues.

Ark`s products are sourced from related but largely non-dependent technologies
within the Group and have been selected to enable Ark to take each product
through development and to benefit from Orphan Drug Status and/or Fast Track
Designation, as appropriate. The Group generally retains ownership of its
product candidates throughout clinical development and intends to conduct it`s
own sales and marketing in certain territories as well as securing marketing
partners in others.

The Group has operations in London, UK and Kuopio, Finland.

Ark`s shares are traded on the London Stock Exchange (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, prospective investors 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]

Hi

Ark erreicht neues jahreshoch gefällt mir wirklich gut wie sich diese aktie entwickelt.

Kurs:125,75p +2,8%

[BrauchGeld]

Hallo

Kurzziel erhöht auf 163p (vorher144p) BUY

Schlusskurs: 125,25p

[BrauchGeld]

Hallo

Hier gibts mehr informationen zu den produkten der Finnischen Firma:

http://www.arktherapeutics.com/pdf/Ark%20Analyst%20presentat…

[BrauchGeld]

Hi

News

Ark Therapeutics Group PLC
14 April 2005


ARK THERAPEUTICS ANNOUNCES FAVOURABLE TRENDS IN INITIAL PHASE II RESULTS FOR
EG005 IN LIPODYSTROPHY


14 April 2005, London UK: Ark Therapeutics Group plc (`Ark` or the `Company`)
today announces initial results from its recently completed exploratory Phase II
study of EG005 for the treatment of lipodystrophy in HIV positive patients.
Preliminary analysis of the results to date has revealed encouraging trends in a
number of clinically important measures that are consistent with EG005 producing
an improvement in the underlying condition. Following completion of the initial
three month study period, a voluntary one year open label extension phase was
available. The majority of patients have elected to continue on active treatment
during this period, with some encouraging initial trends also observed in those
patients who have so far completed this extension phase. Assuming the full
analysis of the results to date and the subsequent results from patients
completing the extension phase are consistent with the beneficial trends seen in
these initial results, Ark anticipates that a Phase III study may be initiated
in 2006.

Lipodystrophy is a serious problem that develops in HIV positive patients on
triple anti-retroviral therapy, one of the most common treatments used in such
patients. It is characterised by an increased, and potentially harmful,
deposition of body fat centrally and the development of unsightly `buffalo hump`
and `pot belly` appearance. Increased central fat deposition is a risk factor
for cardiovascular disease. In certain cases, lipodystrophy is associated with
sudden and unpredictable death through lacticacidosis.

Ark`s exploratory study is a randomised, double-blinded, placebo-controlled
study investigating a range of metabolic, morphological and disease assessment
parameters. A total of 50 patients were enrolled into the trial, with a total
of 46 patients successfully completing the initial three month study period. To
date, 12 of these patients have also completed the one year extension phase.

Physician assessments of the overall status of the condition were carried out
using the Chelsea and Westminster score of lipodystrophy, a validated series of
nineteen assessments. These assessments showed that the mean improvement in
lipodystrophy score after three months in patients treated with EG005 was
approximately twice that seen in patients receiving placebo, with a mean
reduction of 17% from baseline scores for EG005 patients versus 8.6% in those
receiving placebo. Metabolic profiles, including lipids and insulin, showed
changes consistent with the hypothesis of increased metabolism of fat by
increasing mitochondrial efficiency. In both study arms, similar numbers of
patients showed increases and decreases in central body fat. However, DEXA
scans indicated that where central fat reserves increased by more than 5% from
baseline, the potentially harmful increases were lower in EG005-treated
patients. Similarly, where central fat reserves decreased by more than 5% from
baseline, EG005-treated patients had greater reductions. In addition, skin
thickness in the `buffalo hump` area decreased from baseline by 3% in
EG005-treated patients in contrast to a 7% increase in the placebo group.

As part of the study, lean body mass (muscle and bone), as well as body fat, was
assessed after three months to determine whether any signs of muscle wasting/
loss occurred. As a group, patients treated with EG005 on average maintained
their lean body mass, whereas those receiving placebo lost an amount approaching
1%. Unintentional reductions in lean body mass of 3-4% are generally considered
to amount to clinical cachexia.

The overall adverse event profile in both groups was similar and gave no cause
for concern, indicating an acceptable safety profile for EG005.

Commenting on these initial results, Professor John Martin, Ark`s Chief
Scientific Officer, said: `To date, research has not provided effective
therapies for patients suffering from lipodystrophy and we are still
investigating the various parameters that would constitute clinically-relevant
treatment effects. The morphological and clinical chemistry changes we have
observed at three months, albeit in a small number of patients, are in the areas
of concern in lipodystrophy, and beneficial differences have been seen between
the control and treatment groups in favour of EG005. We now need to complete
the full analysis of the three month data and await the data from the rest of
the patients in the one year extension phase.`

Nigel Parker, Chief Executive Officer of Ark, added: `On the results to date,
EG005 could offer valuable clinical benefits to patients as a treatment for
lipodystrophy. Overall, we expect to gather data from approximately 35
patients from the extension phase and will know during the course of this year
how the trends continue and, as a result, what would be required from any Phase
III program. Assuming that the potential for a clinical role for EG005 is
confirmed by this further data, a Phase III study may be initiated during 2006.`

[BrauchGeld]

Hi

Ark Therapeutics Group plc announces today that it
will be holding its Annual General Meeting on 28 April 2005 at 11.30 am at the
offices of Ashurst, Broadwalk House, 5 Appold Street, London EC2A 2HA.

[BrauchGeld]

Moin

Die Intressiert sind sollten sich diese presentation durchlesen.

http://www.arktherapeutics.com/pdf/ark_final_results.pdf

[BrauchGeld]

Hi

Lansdowne kauft 350.000 aktien .

Ark Therapeutics Group PLC
03 May 2005


Ark Therapeutics Group plc
3 May 2005

Notification of Major Interests in Shares


1. Name of Company:

Ark Therapeutics Group plc


2. Name of shareholder having a major interest:

Lansdowne Partners Limited Partnership


3. Please state whether notification indicates that it is in respect of
holding of the shareholder named in 2 above or in respect of a
non-beneficial interest:

As in paragraph 2 above


4. Name of registered holder:

n/a


5. Number of shares acquired:

350,000


6. Percentage of issued class:

0.28%


7. Number of shares disposed:

n/a


8. Percentage of issued class:

n/a


9. Class of Security:

Ordinary shares


10. Date of transaction:

29 April 2005


11. Date Company informed:

3 May 2005


12. Total holding following this notification:

8,928,500


13. Total percentage holding of issued class following this notification:

7.06%


14. Name of contact and telephone number for queries:

Nick Plummer - [phone]


15. Name of company official responsible for making this notification:

Nick Plummer - General Counsel and Company Secretary


16. Date of notification:

3 May 2005

[BrauchGeld]

Ark Therapeutics Group PLC
04 May 2005

Ark Therapeutics Group plc

Ark strengthens international patent position on leading products

London, UK, 4th May 2005: Ark Therapeutics Group plc (`Ark` and the `Company`),
today announces that it has been issued with several new patents for its
products Vitor(TM) in Europe and also Central Africa, Cerepro(TM) in China, and
Trinam(R) in Hungary.

Vitor(TM), an oral therapy for the treatment of muscle wasting (cachexia) that
occurs in patients with cancer, has been granted patent protection in Europe and
also in the ARIPO countries (Kenya, Malawi, Uganda and Zimbabwe), which can be
both be maintained until 2018. Vitor(TM) is a small molecule in Phase III
development in the USA, Canada and Europe. Ark expects to complete enrolment of
the Phase III imminently, giving a target date for initial results to be
available end of Q3 2005. Vitor(TM) works by enhancing mitochondrial activity
and both reducing protein breakdown and enhancing protein synthesis in muscle
cells via the ubiquitin-proteasome pathway. The MHRA recently advised that
should the Phase III study results in cancer cachexia, due in H2 2005, show
relevant and significant clinical benefits in the treatment`s favour, with an
acceptable safety profile, then submission via the new decentralised procedure,
which comes into effect later this year, would be appropriate.

Cerepro(TM), a product for the treatment of patients with operable malignant
glioma, has been awarded a patent in China which can be maintained until 2019.
The 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, is currently in late stage clinical development.
Cerepro(TM) is suitable for patients with operable gliomas, of which there are
approximately 38,000 (1) cases each year in Europe and the USA, and currently
9,000 cases estimated in China. With the progress made to date, Cerepro(TM)
remains on track to become one of the world`s first commercially available
gene-based medicines, following the first gene therapy licensing of P53 in China
earlier this year.

Trinam(R), a novel therapy to prevent blood vessels blocking after vascular
graft access surgery, has been granted a patent in Hungary which can be
maintained until 2017. Trinam(R) is currently in Phase II trials designed to
examine the efficacy and safety of Trinam(R) in patients undergoing
haemodialysis access graft surgery. In the US and Europe, there are an
estimated 150,000 cases a year where Trinam(R) might be used. In patients with
haemodialysis access grafts, up to 60% of the grafts block within a year of
being inserted, and repeat surgery shows more rapid failure rates. Trinam(R)
is expected to extend the useful life of access grafts and reduce costly repeat
procedures. There are currently no approved drug therapies to reduce the
failure rates of access graft procedures for haemodialysis patients.

Dr Nigel Parker, CEO of Ark, said, `We continue to make steady progress with the
granting of our key product patents. Our strategy has been to ensure we secure
patent protection in both traditional and less traditional key pharmaceutical
markets. As the latter countries develop they are expected to provide a
significant business opportunity.`

[BrauchGeld]

Hallo

Ark Therapeutics Group PLC
19 May 2005


Ark signs marketing deal for Kerraboot(R) in Ireland

19 May 2005, London UK: Ark Therapeutics Group plc today announces that it has
signed an exclusive marketing agreement granting BellPharma Limited, the Irish
distributor of healthcare products, the sales and marketing rights to Kerraboot
(R) for the Irish market. Kerraboot(R) is Ark`s novel wound care device for the
management of leg and foot ulcers.

Under the terms of the agreement, Ark will receive an undisclosed upfront
payment and an ongoing royalty of 19% on sales in return for the marketing
rights to Kerraboot(R). BellPharma will also purchase the manufactured product
from Ark and be responsible for marketing to all sectors of the healthcare
community in Ireland, as well as achieving product reimbursement from the
General Medical Scheme.

Lower leg and foot ulceration affects around 1% of the adult population in the
developed world1 and is particularly prevalent amongst the diabetic population
where the ulcers can develop rapidly and are particularly difficult to heal.
Kerraboot(R) provides a new approach to their management in the form of a novel,
non pressurized, boot-like dressing device, which is simple, quick and pain free
to change. Kerraboot(R) facilitates the draining and isolation of exudates such
as matrix metalloproteases, which inhibit angiogenesis, from the ulcer. This
allows natural growth factors, such as Vascular Endothelial Growth Factors
(VEGF), to stimulate healing.

In clinical studies of ulcers managed with Kerraboot(R), reductions in ulcer
sizes of up to 60% have been observed over the four week study period, with both
healthcare professionals and patients expressing a strong preference for
Kerraboot(R) over existing treatments. UK based studies have also shown that
management of ulcers with Kerraboot(R), which does not involve any additional
dressings, can be extremely cost effective.

Mr Paul Higham, Commercial Director of Ark, commented: `We are pleased to
announce this second licensing deal for Kerraboot(R). With its extensive sales
and marketing experience and an in depth understanding of what is required to
make products a success in the Irish market, BellPharma is the ideal partner for
Kerraboot(R) in Ireland. We expect to further progress our international
commercialisation strategy for Kerraboot(R) during 2005.`

For further information please contact:
Ark Therapeutics [phone]
Dr Nigel Parker, Chief Executive
Paul Higham, Director of Commercial Development

Financial Dynamics [phone]
David Yates
Lucy Briggs

Sources:

1 Briggs M, Nelson EA: Topical agents or dressings for pain in venous leg
ulcers; The Cochrane Library, Issue 1, 2002

Notes to Editors

Ark Therapeutics Group plc

Ark is an emerging healthcare group (the `Group`) with one marketed product and
three further lead products in late stage clinical development. Capitalising on
over ten years of research in vascular biology and gene-based medicine, Ark has
a balanced product portfolio targeted at specific unmet clinical needs within
vascular disease and cancer. These are large and growing markets, where
opportunities exist for effective new products to generate significant revenues.

Ark`s 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 Company`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
Yl(TM)-Herttuala of the AI Virtanen Institute at the University of Kuopio,
Finland, all of whom continue to play leading roles in the Company`s research
and development programmes.

BellPharma Limited

BellPharma is a privately owned Irish pharmaceutical company, established in
June 2003, with the aim of providing the Irish market with quality & affordable
medicines and healthcare products.

BellPharma`s product focus is in three main areas; niche patent controlled
medicines, affordable medicines (generics), and specialist hospital products
(wound care). The company is currently focussing its efforts on sales and
marketing rather than development, and in-licenses products exclusively for the
Irish market.

BellPharma`s management team has extensive experience in the pharmaceutical/
healthcare business both within Ireland and abroad, and a thorough understanding
of the dynamics of the Irish pharmaceutical market, which differs considerably
from other European countries.

BellPharma plans to capitalise on the opportunity for significant growth in the
generic market in Ireland, which is still relatively underdeveloped, as well as
providing the Irish consumer with innovative & niche healthcare products.

[BrauchGeld]

Nabend


Hansa Trust PLC kauft weitere 500.000 aktien.

Ark Therapeutics Group PLC
7 June 2005

SCHEDULE 10

NOTIFICATION OF MAJOR INTERESTS IN SHARES


1) NAME OF COMPANY

Ark Therapeutics Group PLC

2) NAME OF SHAREHOLDER HAVING A MAJOR INTEREST

Hansa Trust PLC

3) Please state whether notification indicates that it is in respect of
holding of the Shareholder named in 2 above or in respect of a
non-beneficial interest or in the case of an individual holder if it is a
holding of that person`s spouse or children under the age of 18

As in paragraph 2 above

4) Name of the registered holder(s) and, if more than one holder, the
number of shares held by each of them.

n/a

5) Number of shares/amount of stock acquired.

500,000

6) Percentage of issued Class

0.39%

7) Number of shares/amount of stock disposed

n/a

8) Percentage of issued Class

n/a

9) Class of security

Ordinary shares


10) Date of transaction

3 June 2005


11) Date company informed

6 June 2005


12) Total holding following this notification

4,000,000


13) Total percentage holding of issued class following this notification

3.16%


14) Any additional information

Nick Plummer - [phone]


15) Name of contact and telephone number for queries

Nick Plummer - Company Secretary

16) Name and signature of authorised company official responsible for
making this notification

[BrauchGeld]

Ark Therapeutics Group PLC
14 June 2005


Ark signs marketing deal for Kerraboot(R) in South Korea

14th June 2005, London UK: Ark Therapeutics Group plc today announces that it
has signed an exclusive marketing agreement granting BL&H Co Ltd, a South Korean
distributor of healthcare products, sales and marketing rights to Kerraboot(R)
for the South Korean market. Kerraboot(R) is Ark`s novel wound care device for
the management of leg and foot ulcers.

Under the terms of the agreement, Ark will receive a double digit royalty on net
sales in return for the marketing rights to Kerraboot(R). BL&H will purchase the
manufactured product from Ark and be responsible for marketing to all sectors of
the healthcare community in South Korea, as well as achieving product
reimbursement from the Korean regulatory authority.

Lower leg and foot ulceration affects around 1% of the adult population in the
developed world(1) and is particularly prevalent amongst the diabetic population
where the ulcers can develop rapidly and are particularly difficult to heal.
There are an estimated two million diabetics in South Korea, 15% of whom would
be expected to have a leg/foot ulcer at any one time.

Kerraboot(R) provides a new approach to the management of these ulcers, in the
form of a novel, non pressurized, boot-like dressing device, which is simple,
quick and pain free to change. Kerraboot(R) facilitates the draining and
isolation of exudates such as matrix metalloproteases, which inhibit
angiogenesis, from the ulcer. This allows natural growth factors, such as
Vascular Endothelial Growth Factors (VEGF), to stimulate healing. In clinical
studies of ulcers managed with Kerraboot(R), reductions in ulcer sizes of up to
60% have been observed over the four-week study period, with both healthcare
professionals and patients expressing a strong preference for Kerraboot(R) over
existing treatments. UK based studies have also shown that management of ulcers
with Kerraboot(R), which does not involve any additional dressings, can be
extremely cost effective.

M Paul Higham, Commercial Director of Ark, commented: `This is our third
licensing deal for Kerraboot(R), and our first in the Asian market. BL&H has a
strong healthcare product distribution capability in South Korea and we look
forward to working with them under the terms of this agreement. As we roll out
our international commercialisation strategy for Kerraboot(R), we expect to
announce further licensing deals in 2005.`

[BrauchGeld]

Ark Therapeutics Group PLC
21 June 2005



Ark completes patient enrolment for VitorTM Phase III study
in cancer cachexia



London, UK, 21 June 2005: Ark Therapeutics Group plc (`Ark` and the `Company`),
the specialist healthcare group, today announces that patient enrolment for the
Phase III study of VitorTM, for the treatment of muscle wasting in cancer
(cachexia), has been completed. The company expects preliminary results to be
available towards the end of 2005.



The Phase III study is a blinded, placebo controlled, three month study in
patients with solid tumours (colon, pancreas, non small cell lung) exhibiting
clinical cachexia, defined as involuntary loss of 5% or more of body weight.
Ark originally planned to recruit around 160 patients. However a final review by
the steering committee found `in trial` cancer deaths, unrelated to the study,
were greater than the original estimate had planned for. The Company therefore
extended enrolment to 200 patients to adjust for this. The study is being
conducted in North America and Europe.



VitorTM is an oral therapy being developed for the treatment of cachexia (muscle
wasting) in cancer, a secondary, often fatal, condition commonly seen in
patients with cancer. Between 40 to 90 percent of all cancer patients with
solid tumours experience cachexia, and it is particularly prevalent in the
common cancers such a lung, stomach and colon cancer. It is estimated that
there will be over three million new cases of cancer in Europe and the US in
2005 of which a large majority will involve solid tumours. There are no
pharmaceutical products currently approved specifically for the treatment of
muscle wasting in cancer and VitorTM has been awarded Fast Track Designation by
the FDA.



Dr. David Eckland, Research and Development Director at Ark, commented: `We are
pleased with the progress of the Phase III programme for VitorTM and with the
way recruitment has been finalised with the protocol extension. We look forward
to seeing the preliminary results towards the end of the year.`

[BrauchGeld]

Hi

Ark Therapeutics Group PLC
07 July 2005

Ark Therapeutics Plc

Board Appointment



07 July 2005, London UK: Ark Therapeutics Group plc (`Ark` or the `Company`),
the specialist healthcare group, today announces the appointment of Dr. Bruce
Carter as a non-executive director and member of Ark`s remuneration committee
with immediate effect.



Dr Carter, who has over 25 years of pharmaceutical experience, is currently
President and Chief Executive Officer of ZymoGenetics Inc (`ZymoGenetics`), the
$1 billion NASDAQ-listed biopharmaceutical company focused on the discovery,
development and commercialisation of protein-based therapeutics for the
prevention or treatment of human diseases. In 1988 ZymoGenetics was acquired by
Novo Nordisk and operated as a wholly owned subsidiary until late 2000, when the
company regained its independence through a spinout transaction, which Dr Carter
led. Prior to his role as CEO of ZymoGenetics, Dr Carter was Corporate
Executive VP and CSO of Novo Nordisk, and was responsible for over 2000
employees and a budget of $300 million.



Dr Carter has extensive experience at board level. He was on the Board of
Management of Novo Nordisk from 1988 to 2000. He is currently on a number of
biopharmaceutical boards including Renovis, a biopharmaceutical company
developing drugs to treat neurological diseases and disorders and Epigemomics, a
company listed on the Deutsche Borse that focuses on improving the prognosis of
patients with cancer and other common diseases.



Commenting on this appointment, Dennis Turner, Chairman of Ark, said: `We are
delighted to welcome Bruce to Ark. He has an established reputation and is
well respected within the international biopharmaceutical industry. His
expertise in America will add a significant new dimension to the Board and he
will be a great asset to Ark as we advance our pipeline towards
commercialisation.`

[BrauchGeld]

Hallo



Ark Therapeutics Group PLC
21 July 2005


Trinam(R) Successfully Completes First Stage of Phase II Study


Preliminary data to be presented at ACS in October 2005 - Abstract awarded
`Exceptional Merit`


London, UK, 21 July 2005: Ark Therapeutics Group plc (`Ark` and the `Company`),
the emerging healthcare group, today announces that it has completed patient
enrolment for the low dose arm of its Phase II study for Trinam(R) (EG004) and
has received approval to move to the higher dose. Trinam(R) is Ark`s novel
therapy to prevent blood vessels blocking (intimal hyperplasia) after vascular
graft access surgery in kidney failure patients.

The preliminary results of the first stage will be presented at the annual
meeting of the American College of Surgeons (ACS) in San Francisco, October 16 -
20 2005. The abstract is one of twelve selected from the 309 abstracts
initially submitted to have been awarded `Exceptional Merit`, and one of only
two in the vascular category.

The Phase II study in up to 20 patients, is taking place at three centres in the
USA and is an open label ascending dose study, designed to examine the effects
and safety of Trinam(R) in intimal hyperplasia prevention compared with standard
care. Six patients were entered into the low dose stage and following review of
the data, the company has been given clearance by the Data Safety Monitoring
Board to proceed to the higher dose. The FDA has also given notification that
six patients are adequate for the low dose stage. Earlier Phase I and
pre-clinical studies with Trinam(R) have respectively demonstrated the first
ever successful adventitial (from outside the blood vessel) gene transfer in
humans and a significant effect in preventing intimal hyperplasia.

Trinam(R) is a combination of a Vascular Endothelial Growth Factor (VEGF) gene
in an adenoviral vector and Ark`s biodegradable collagen collar local delivery
device (EG001). Trinam(R) is placed by the surgeon, at the end of surgery,
around the join of the access graft and the vein, where blockages usually occur.
The initial target market for Trinam(R) is haemodialysis graft access surgery,
a treatment for kidney failure patients in which a plastic tube is grafted
between blood vessels in the forearm to enable regular blood filtration. In the
US and EU there are an estimated 150,000 cases a year where Trinam(R) might be
used. Trinam(R) has been granted Orphan Drug Status by both the FDA and EMEA.

Dr Jeff Lawson, Principal Investigator, Duke University Medical Centre,
commented: `We are through the first learning curve in using this novel product
and the results to date look very interesting. If Trinam(R) is proven to help
prolong the patency of haemodialysis access grafts, it would significantly
improve the quality of life for these very sick and difficult to manage
patients.`

Dr Nigel Parker, CEO of Ark, commented: `We are pleased to have achieved this
first trial milestone for Trinam(R) and we will now press on and enrol the
second stage of the study. We look forward to presenting the data at the ACS
meeting and are encouraged that the Phase I and main preclinical and
bio-distribution studies were also accepted for presentation.`

[BrauchGeld]

Ark Therapeutics` Trinam Backs Strong Buy

Thursday, July 21, 2005 3:36:48 AM ET
Dow Jones Newswires



0730 GMT [Dow Jones] Ark Therapeutics (AKT.LN) completion of the low dose phase of Trinam phase II trial and news it has started to recruit patients for the phase III trial back a strong buy recommendation, says Nomura. "This news is supportive evidence that the Trinam may already be demonstrating some efficacy at keeping the vascular access shunts patent in haemodialysis patients," it says. Feels investors will also have to ascribe value to Trinam, which has been relatively ignored to date. Trades unchanged at 97p.

[BrauchGeld]

Hallo

Calivet Limited kauft 4 millionen aktien .

Ark Therapeutics Group plc

NOTIFICATION OF MAJOR INTERESTS IN SHARES


London, UK, 29 July 2005: Ark Therapeutics Group plc (the `Company`) was
informed today by Calivet Limited (`Calivet`) that Calivet had, on 21 July 2005,
acquired 4,000,010 ordinary shares of 1 pence each in the Company, representing
approximately 3.14 per cent of the shares currently in issue. Calivet has
informed the Company that these are the only shares it holds in the Company.

[BrauchGeld]

Ark Therapeutics Group PLC
05 August 2005

Ark makes breakthrough in targeted gene therapy delivery

Avoids harmful consequences of therapeutic gene being inserted in wrong place



5 August 2005: Ark Therapeutics Group plc (`Ark`) announces today that its
scientists in Finland have discovered a novel gene therapy delivery technology
which selectively inserts DNA into the specific therapeutic site in the genome
(targeted integration). This technology is the subject of an Ark PCT filing.



The existing generation of integrating vectors in clinical trials, based mostly
on retroviral, adeno-associated virus and lentiviral technologies, are not
site-specific and carry the risk of a random gene insertion into an undesired
and potentially harmful position on the chromosomes. The risks associated with
non-specific integrating vectors became apparent in the X-linked severe combined
immune deficiency disease (X-SCID) gene therapy trial, in 2002. The trial used
a retrovirus, which was found to have inserted next to the leukaemia inducing
oncogene, as a vector. Although the treatment was beneficial, three out of
eleven patients treated in the study developed a leukaemia-like disease as a
result of undesired random insertion. Ark`s novel technology could herald a
breakthrough in molecular medicine because it removes the potentially harmful
consequences of a beneficial therapeutic gene being inserted into the wrong
place, and could thus greatly improve the predictability and safety of gene
therapy.



The technology is based on a fusion protein that catalyses the targeted
integration of the treatment gene into a benign site on the human chromosomes.
The process whereby the DNA carrying vector inserts the treatment gene in the
chromosome is achieved by a specific DNA-binding nuclease-integrase fusion
protein. The fusion protein breaks the DNA chain specifically in the benign
locus of 28s ribosomal RNA gene (28s rDNA) and inserts the therapeutic gene at
this site. Controlling the site where the insertion occurs has been so far very
difficult, even with hybrid vectors or designed zinc finger proteins. Ark`s
novel vector technology removes the risk of such potentially harmful random
insertions by this molecular chromosome locus targeting approach.



Commenting on this discovery, Professor Seppo Yla-Herttuala, Consultant
Director of Molecular Medicine in Finland, said: `This is potentially a highly
significant step forward in gene therapy, enabling us to deliver therapeutic DNA
precisely in a way that it will provide the medical benefit. Gene therapy has
always offered the possibility of great therapeutic benefit but has been
hampered by the difficulty of inserting the beneficial gene in the right place.
Whilst we have further work to do, the ability potentially to overcome this
problem is a vital breakthrough, improving the overall efficiency and safety in
an area of medicine that we expect to become increasingly important in the near
future.`

[BrauchGeld]

Ark Therapeutics Worth Backing - Numis

Friday, August 05, 2005 4:07:20 AM ET
Dow Jones Newswires



0755 GMT [Dow Jones] Ark Therapeutics (AKT.LN) is becoming a scientific powerhouse, exploiting its scientific intellectual capital to maximize its earnings potential in the medium term, says Numis. Says Ark has recently made a number of positive strides and has ample programs to succeed in at least some areas. It has perhaps one of the fullest and more mature pipelines of many of its European peers and at these levels is worth backing. Keeps buy recommendation with a 145p target price.

[BrauchGeld]

Hallo

Ark Therapeutics ist eines der solidesten Biotechs die ich im Depot habe ,das Unternehmen überzeugt durch ständig positive news.
In U.K. ist der Biotechsektor etwas unter die räder gekommen auch Ark konnte sich nicht der schlechten performance entziehen wobei die aktie sich relativ gut gehalten hat.
Bei Ark wird man nichts finden was gegen ein investment spricht.
Diese Aktie wird defenitiv zu den gewinnern gehören.

Marktkap:185mio€
Cash:59,5mio€

Hab diesen Thread etwas vernachlässigt hier die vergangenen News:

Ark Therapeutics Group PLC
05 October 2005

Ark completes development of oxLDL diagnostic kit for prediction of heart attack
risk

Product now CE-marked in preparation for commercialisation


London, UK, 5 October 2005: Ark Therapeutics Group plc (`Ark`), today announces
that it has completed the development and European CE marking of its oxidised
low density lipoprotein antibody testing kit, oxLDL. The diagnostic kit will be
used to predict whether an individual is at risk of having a heart attack.

Patients with cardiovascular disease exhibit a build up of fats and abnormal
tissue, known as atherosclerotic plaques, on the inside of their blood vessels.
Whilst plaques can lay dormant with minimal risk to the patient, they can become
active and unstable, eventually rupturing and releasing fragments of plaque into
the bloodstream. This `breakaway` plaque is circulated by the blood and can
lodge in the coronary artery causing a heart attack, or in the blood vessels
supplying the brain causing a stroke.

As plaque becomes active, it releases a specific chemical, an oxidised form of
low density lipoprotein (oxLDL), into the blood stream in amounts that reflect
the level of the plaque`s instability. As such, oxLDL has become increasingly
recognised as a key marker of heart attack risk(1), as the higher its level in
the blood, the more likelihood there is of the plaque breaking away and causing
a serious cardiovascular event.

Attempts to produce a reliable and easy to use test to measure oxLDL have not
been successful to date, as the oxLDL molecule only exists for a very short time
in the blood. However, as oxLDL is released into the blood, it rapidly produces
an antibody response. Ark`s test, the first of its kind, is a highly sensitive
measure of the level of antibodies that are produced in response to oxLDL. The
test also contains a control chemical to check whether a positive result is real
or false.

Clinical results to date using Ark`s test have shown that the test is applicable
to approximately 75% of people and is highly predictive. In a study of patients
with chest pain entering hospital for investigation, 81% of the patients who
tested positive using Ark`s kit were subsequently confirmed as having a serious
cardiovascular problem (heart attack or unstable angina). The test was even
more accurate where heart attack occurred. C-reactive protein (CRP), one of the
current `gold standards` in predicting risk of cardiovascular problems, was
predictive in only 29% of the cases in the same study.

Professor John Martin, Chair of Cardiovascular Medicine at University College
London and Chief Scientific Officer at Ark, commented: `This new diagnostic is
highly predictive and has the potential to save many lives. It should prove a
very useful addition to the overall cardiovascular risk testing approach.`

Dr Nigel Parker, Chief Executive of Ark, added: `This is the second product that
Ark has taken all the way through the development process to CE marking. We
shall now be seeking specialist diagnostic partners to help us market the
product and ensure that it realises its full commercial potential.`

[BrauchGeld]

Ark Therapeutics Group PLC
18 October 2005


18 October 2005

Ark Therapeutics Group plc


Positive Results of Trinam(R) Gene Therapy Presented at American College of
Surgeons Congress

- Breakthrough treatment for kidney failure patients -

- Access grafts remain functional three times longer than previous procedures-


Ark Therapeutics Group plc (`Ark`) today announces the publication of positive
results from an ongoing Phase II trial of Trinam(R), its novel gene therapy to
prevent blood vessels blocking in kidney dialysis patients who have undergone
vascular access graft surgery. The data to date, which will be presented later
today at the 2005 Annual Clinical Congress of the American College of Surgeons
in San Francisco, show that access grafts continue to remain functional three
times longer than previous procedures, with no systemic distribution of the
inserted gene being found.

Patients in renal failure depend on good vascular access for haemodialysis,
which removes blood from the body, cleans it and returns it, three times a week.
Without dialysis these patients would die. A common method of gaining access
to the circulatory system is via an artificial blood vessel (vascular access
graft) sewn between an artery and a vein in the forearm. However, in a majority
of patients, the grafts become blocked due to overgrowth of muscle tissue inside
the blood vessel (intimal hyperplasia) and this requires further complex surgery
to allow dialysis to take place.

Trinam(R) 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 VEGF gene
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.

The Phase II trial of Trinam(R) is an ongoing, open-label, standard
care-controlled clinical trial that primarily assesses safety, with efficacy as
a secondary measure. In the study, six patients with end-stage renal disease
dependent on regular haemodialysis for kidney function received one dose of 4 x
10 (9) particles at the time they underwent surgery either to implant a first
vascular access graft or to insert a new graft in a different location after
failure of a previous access procedure.

After as long as a year of follow-up, none of the patients exhibited serious
side effects, other than those consistent with the nature of the operation and
condition and no systemic distribution of Trinam(R) was evident. The VEGF gene
was not detected outside the specific vein area treated by the surgeon. Whilst
one patient had to be withdrawn from the trial because of an infection believed
to have been contracted at the time of surgery, the remaining five patients had
encouraging prolonged graft patency. Four patients ongoing in the trial had
previously had multiple failed access procedures prior to the trial. The mean
patency of previous access procedures in these patients was 4.5 months. Using
Trinam(R), the mean patency has been extended so far to 14 months and in all of
these patients the grafts continue to remain patent and functional for dialysis.

The study remains ongoing with a higher dose of VEGF (4 x 10 (10)) particles and
is being conducted at Duke University, The University of Miami and Vascular and
Transplant Specialists in Norfolk, Virginia.

In the US and Europe, there are an estimated 150,000 cases each year where
Trinam(R) might be used. In patients fitted with haemodialysis access grafts,
up to 60% of the grafts block within a year of being inserted and repeat surgery
shows more rapid failure rates(1). There are currently no approved drug
therapies to reduce failure rates of haemodialysis access graft procedures. The
clinical need for an effective treatment is such that the National Institutes of
Health in the US has highlighted it as a priority requiring a solution in the
Healthy People Directive 2010.

Commenting on the results, Dr Jeffrey Lawson, Associate Professor of Surgery and
Pathology at Duke University, North Carolina and lead investigator in the trial,
said:

`Instead of having the majority of vascular access grafts re-operated on within
a year, sometimes each two or three times, this treatment preserves the graft`s
functionality for a longer period, so patients can go about their lives normally
and have fewer surgical interventions and complications. By delaying the rate
of failure of dialysis access grafts, the treatment may also save healthcare
systems some $15,000 to $20,000 for each intervention. This kind of technology
is very exciting and some day will be in general use.`


Nigel Parker, Chief Executive of Ark, added:

`These are extremely encouraging results, representing a breakthrough in
targeted gene medicine and demonstrating Ark`s expertise and leadership in this
emerging field. We had planned to establish primarily safety and systemic
distribution in this low dose group and to get human proof-of-principle results
of this magnitude exceeds our expectation. We are particularly pleased to see
that patients` grafts continue to remain open after a period far beyond what
might be expected. If validated during the remainder of the development
programme, Trinam(R) has the potential to save many lives, to bring substantial
improvement to the quality of life of chronic renal failure patients undergoing
haemodialysis, and to save significant healthcare costs.`

[BrauchGeld]

Ark Therapeutics Group PLC
20 October 2005


Ark receives licence to manufacture first gene medicine for commercial supply


London, UK, 20 October 2005: Ark Therapeutics Group plc (`Ark`) announces today
that, following an inspection by the Finnish National Agency for Medicines, on
behalf of the European Medicines Agency (EMEA), its facility in Kuopio, Finland
has received Good Manufacturing Practice (GMP) Certification to manufacture
commercial supplies of its adenoviral-based gene medicine CereproTM, a gene
based medicine for the treatment of brain cancer.

Ark`s facility, in Kuopio, Finland is believed to be the only facility outside
of China to have been licensed to manufacture gene based medicines for
commercial supply.

Nigel Parker, CEO of Ark, commented: `This is a tremendous achievement by the
Company. A number of years of meticulous planning and work have gone into
achieving this certification and it endorses our leadership position in this
upcoming area of molecular medicine.`

[BrauchGeld]

Ark Therapeutics Group PLC
28 October 2005


Ark Commences CereproTM Corroborative Study


28 October 2005: Ark Therapeutics Group plc (`Ark`) today announces that,
following approval of its manufacturing facility in Finland and subsequent batch
release of clinical trial materials, it has commenced the corroborative study
(Study 904) of its novel gene-based medicine CereproTM for the treatment of
operable malignant glioma (brain cancer). Study 904 will take place in
approximately 40 centres in Europe and Israel and aims to recruit up to 250
patients.



CereproTM has already shown highly significant results in two clinical efficacy
and safety studies, almost doubling mean survival times and was well tolerated
with an acceptable safety profile. CereproTM, a European and US Orphan Drug,
is manufactured in Ark`s facility in Kuopio, Finland which has recently received
the world`s first commercial licence for gene medicine production1. The Company
has also announced today, in a separate press release, that its filing for
Marketing Authorisation Approval in Europe has been accepted by the European
medicines regulatory authority, the EMEA, as valid and the formal review is now
able to commence.



Dr David Eckland, Research and Development Director at Ark, commented: `Ark is a
pioneer in the field of gene therapy and CereproTM is potentially the first gene
therapy product1 that could be approved in this fast emerging area. We have been
very pleased with the helpful and constructive approach taken by the various
European regulatory agencies and have recently finalised the important
manufacturing aspects. Results from the first two efficacy and safety studies
have been extremely encouraging and with the good quality of life seen in the
extended survival period, CereproTM offers hope for patients who suffer from
this dreadful disease.`



Dr Nigel Parker, Chief Executive Officer of Ark, commented: `Ark has made
tremendous progress in all its key gene-based medicine programmes this year. As
the results come through, it is becoming clear that DNA-based medicines are
coming of age, offering large clinical benefits with good safety profiles in
hitherto difficult to treat diseases. Ark is working diligently to take up its
leadership position in this new medical area.`

[BrauchGeld]

Ark Therapeutics Group PLC
28 October 2005


Preliminary Results of VitorTM Study Show

Clear Therapeutic Effect in Cancer Cachexia


28 October 2005 - Ark Therapeutics Group plc (`Ark`) announces today that the
preliminary results of the VitorTM study in 200 patients with cancer cachexia
indicate that the product changes the pattern of weight loss in the three types
of cancer (colorectal, lung and pancreatic) in the study.


Patients entering this study were all terminal cancer patients and had already
lost an average of 15% of their body weight. A positive treatment effect with
VitorTM was observed across the treatment group, irrespective of cancer type.
Whilst initially continuing to lose weight over the first four weeks of the
study, colorectal and lung cancer patients then gained weight over the next
eight weeks to study end (week 12) whereas placebo patients lost weight (VitorTM
daily rate of change +0.025lbs vs placebo -0.022lbs). Pancreatic cancer
patients (the more aggressive of the cancers studied), whilst not gaining weight
after the first four weeks of the study, exhibited a marked reduction in the
daily rate of weight loss compared with placebo (VitorTM -0.02lbs per day vs
placebo -0.06lbs per day) over the remainder of the study. The positive effects
of VitorTM treatment were also evident in the initial analysis of hand grip
strength.


The initial results from this study, which is the first time VitorTM has been
tested in humans in this disease, demonstrate a proof of principle in humans
consistent with that previously found in pre-clinical models and the novel mode
of action reported in late 2004.


Professor John Martin, Chief Scientific Officer at Ark, said: `The positive
effects observed in this study of VitorTM would offer cancer patients a very
relevant clinical benefit as weight loss and the associated weakness are some of
the most distressing and dangerous aspects of late stage cancer.`


Nigel Parker, Chief Executive Officer, said `This first data cut looks very
interesting and we look forward to completing the full study analysis to
determine what further activities may be required for regulatory filing. This
has been a tremendous two weeks at Ark. With Trinam(R)`s low dose results
showing a tripling of haemodialysis access graft patency, our Finnish
manufacturing facility receiving the world`s first(1) licence to produce a gene
medicine for commercial supply, the EMEA accepting the CereproTM marketing
authorisation application for review and finally these first proof of principle
VitorTM results, we have ended this intense period of newsflow in exceptional
shape.`

[BrauchGeld]

Ark Therapeutics Group PLC
28 October 2005


CereproTM Marketing Authorisation Application

Review Commences in Europe

- Dossier for potentially the world`s first gene therapy product 1 accepted by
EMEA as `valid` -


28 October 2005: Ark Therapeutics Group plc (`Ark`) today announces that its
Marketing Authorisation Application (MAA) for CereproTM, a novel gene-based
therapy for operable malignant glioma (brain cancer), has been filed with the
European medicines regulatory authority, the EMEA, and that the application has
been accepted for review.


The application for CereproTM, a designated Orphan Drug, has met the submission
requirements of the important validation stage, and formal review by the
regulators has commenced. Earlier in the year, the Company announced that the
EMEA had appointed Rapporteurs to review the MAA via the centralised regulatory
process, which is the standard route for all biologics, and more recently Ark
has announced that its Finnish manufacturing facility had received a licence to
manufacture CereproTM for commercial supply. The Company is also announcing in
a separate press release today that it has commenced a corroborative study of
CereproTM, Study 904, in up to 250 patients.


CereproTM, a novel gene-based medicine, has undergone three clinical studies
during its development to date, a Phase I study establishing safety and posology
(dosing and method of administration) and two safety and efficacy studies. In
these studies CereproTM treatment produced an average extension of 7.5 months of
life, giving around 15.5 months survival in a disease where most patients
currently only live for around 8 months. CereproTM has Orphan Drug Status in
Europe and the USA and is manufactured by Ark in Finland.


Dr David Eckland, Research and Development Director at Ark, said: `We are
working in a breakthrough area of medicine, and acceptance of the CereproTM file
by the regulatory authorities in Europe is an enormous achievement and the key
milestone that we have been seeking for this product. The regulatory
authorities have been extremely supportive throughout this process and we look
forward to working with them during the review.`


Dr Nigel Parker, CEO of Ark, commented: `If the review by the EMEA is
successful, CereproTM will be the world`s first gene therapy product1. An
increasing body of evidence suggests that gene therapy has the potential to
deliver solutions for many diseases that are untreatable today and Ark is
rapidly becoming recognised as the world leader in this frontier area of
medicine.`

[BrauchGeld]

Auch die Analysten sind alle positiv gestimmt.

http://www.citywire.co.uk/News/NewsArticle.aspx?VersionID=77…

BrainsTrust News: Ark Therapeutics floats higher on Cerepro progress

Shares in BrainsTrust Small Cap stock and Citywire tip Ark Therapeutics are up by 4% on news of strong progress for two of its most promising drugs, giving a lift to Framlington`s Roger Whiteoak.

Ark has filed a marketing authorisation application for its Cerepro gene-base therapy for malignant glioma or brain cancer. It has been filed and accepted by Emea, Europe`s medicines regulatory authority.

Cerepro has been designated orphan status and Ark`s Finnish manufacturing facility has received a licence to manufacture it for commercial supply. So far Cerepro has undergone clinical studies and extended the life of terminal patients by 7.5 months on average, giving survival rates of 15.5 months as opposed to the previous standard of 8 months.

The acceptance of Cerepro by the European regulatory authorities is a breakthrough as it is the world`s first gene therapy product.

On top of this Ark has announced the commencement of a corroborative study for Cerepro with up to 250 patients. It has also revealed positive results from its Vitor study using 200 patients suffering cancer-related weight loss. Irrespective of cancer type all patients experience positive effects, a boon for its first trial in humans.
A spate of positive newsflow from the company recently has helped its share price steady itself after a fall from 127p to less than 100p recently. It is now up 3.75p at 99.75p. Citywire tipped Ark at 119p in April on the back of buying by Whiteoak, Citywire AAA-rated for his management of Framlington UK All Companies (Framlington UK Smaller Companies Acc), and Jamie Allsopp, manager of New Star Hidden Value (New Star Hidden Value A).

Gene-based therapy has been something of a holy grail in recent years as the decoding of the human genome creating a great deal of hope for a flood of gene-based treatments for various ailments which has not yet materialised.

Broker comment has been positive with Numis rating it a buy: `It seems pretty good news, the trend seems to be going in the right direction.`

House broker Nomura is even more enthusiastic with a buy and a 355p share price target. Nomura said: `We think that as Ark has sufficient cash to take all of these products through registration to approval, the share price should start to more realistically reflect the portfolio`s worth.`

At the last analysis of Citywire`s BrainsTrust Small Cap index Ark rose four places to 23rd. The BrainsTrust reflects the favourite stocks of the UK`s top performing smaller companies managers according to how overweight they are in stocks.

[BrauchGeld]

Tuesday - Business

The Times October 18, 2005

New treatment could boost Ark
By Richard Irving



A NEW drug based on one of the oldest gases in the universe can help to prolong the life of patients suffering severe kidney failure by more than a year, tests to be released today will show.
Ark Therapeutics, the London-listed drugs maker, will publish new results proving that a treatment based on nitric oxide can stop blood vessels blocking in patients undergoing kidney dialysis.



The findings, which will be presented at the annual clinical congress of the American College of Surgeons in San Francisco, will bolster analysts’ expectations that the medicine, called Trinam, could eventually be worth several hundred million pounds a year to Ark.

Patients in renal failure typically need dialysis up to three times a week. Over time, their blood vessels badly scar and need replacing with articial grafts. However, these tubes eventually block and require expensive and painful surgery. With each intervention, the failure rate escalates and the patient’s life expectancy drops.

It is estimated that about 160,000 patients a year have operations to renew skin grafts. The proceedure costs about $20,000 (£11,000) and lasts on average less than six months.

Ark has developed a new gene that protects blood vessels from blocking by slowly releasing nitric oxide into the affected area. In tests on patients, the grafts have lasted up to 14 months without requiring further surgery.

Nigel Parker, Ark’s chief executive last night told The Times: “This is a breakthrough in targeted gene therapy. If validated during the rest of the trial, Trinam has the potential to save many lives and to substantially improve the quality of life among patients suffering chronic renal failure.”

[BrauchGeld]

Moin

Ich Liebe meine Britischen Biotechs sie machen mich Glücklich.
Auch hier wird bald die Post abgehen.

Aktueller Kurs:107p

Nomura has a strong buy on Ark Therapeutics (LSE: AKT.L - news) (raising the present value estimate to 359p from 249p).

[BrauchGeld]

Ark Therapeutics ist ein langfrist Investment 1.klasse.



Ark Therapeutics Group PLC
03 November 2005

Ark Therapeutics receives €2.19 million grant for new manufacturing facility Finland



Largest ever grant awarded to biotechnology company by TE-Centre



London, UK, 3 November 2005: Ark Therapeutics Group plc (`Ark`) announces today
that it has been awarded a grant of €2.19 million to support the Company`s
investment in a new GMP manufacturing facility (MT4) in Kuopio, Finland. The
grant is from The Employment and Economic Development Centre of Finland (`
TE-Centre`) and is believed to be the largest awarded to the Biotech-Pharma
Industry by the TE-Centre since its foundation in 2000.



Ark currently has a unique cGMP facility in Kuopio which is currently being
prepared for commercial-scale manufacture of Cerepro(TM)(gene-based medicine for
treatment of brain cancer). The new MT4 facility will significantly increase
Ark`s manufacturing capacity and scope in the gene-based medicines where the
Company is one of the world`s leaders. The expanded capabilities will allow Ark
to produce commercial-scale cGMP medicines for Cerepro(TM)and its other lead
gene-based medicine Trinam(R) (haemodialysis access graft surgery), and also to
manufacture trials supplies for its earlier pipeline opportunities as they move
from preclinical into Phase I human trials in compliance with the new 2005
European pharmaceutical legislation.



Work on MT4 has already commenced and the Company expects it to be operational
for validation to commence towards the end of 2007. The TE-Centre has a
successful track record in promoting the development of key sectors in Finland,
working with the European Union, which will contribute 50% of the grant awarded
to Ark from the European Regional Development Fund.



Dr Nigel Parker, Chief Executive Officer of Ark, commented: `We have a very
constructive relationship with the national authorities in Finland who fully
understand our commitment to the sector and to developing this unique expertise
in Finland. We are very pleased to have been awarded this significant grant.`

[BrauchGeld]

Auch hier ist Charttechnisch der weg frei nach oben.

http://finance.yahoo.com/q?s=akt.l

[BrauchGeld]

Hier könnt Ihr über das Potential von Ark nachlesen:

http://www.arktherapeutics.com/pdf/interim05.pdf

Freue mich schon auf die nächste Woche.

[BrauchGeld]

Moin

Der Britische Biotechsektor scheint endlich die negative performance hiter sich zuhaben.

Und weiter gehts nach oben:
http://finance.yahoo.com/q?s=akt.l

[BrauchGeld]

Ark ist auf dem weg neue höhen zu erklimmen.

http://finance.yahoo.com/q?s=akt.l

[BrauchGeld]

Hallo

Ark Therapeutics eine Topaktie und das in jeder hinsicht.

Will the investors who boarded Ark Therapeutics at the start of the voyage see profits flood in? City writer Ken Clay reports
Searching for a drug to meet a clear, unmet need is an attractive proposition. For the company that gets it right and secures regulatory approval, the reward is likely to be a clear run at the market with no need to displace existing treatments. Financial rewards aside, there’s also the bonus of having done something for humanity.

The attractions to the potential investor are clear. But there are risks too as a lot more hopefuls fall by the wayside than actually make it to the market.

Ark Therapeutics, which came to the Stock Exchange earlier this year offering shares at 133p, looks for areas of clear, unmet medical need in vascular disease and cancer. There, Ark points out, effective new products can generate significant revenues without having to displace existing treatments. It also focuses on specialist areas of medicine where it says development and marketing costs are generally lower and which can benefit from Orphan Drug and Fast Track regulatory procedures to minimise dependency on pharmaceutical partners.

The company, part British, part Finnish, combines a London-based group researching the biology of the vascular system and its diseases with a group based in Finland focusing on gene-based medicine and the development of new vectors and delivery systems. Its founding scientists, Professor John Martin and Dr Stephen Barker of University College, London, and Professor Seppo Ylä-Herttuala, of the University of Kuopio, Finland, continue to have leading roles in the group’s research programmes. The commercial drive comes from the chief executive officer Dr Nigel Parker who, prior to joining Ark, had been involved in the launch of more than 20 drugs.

This year’s public offer, which was more than three times oversubscribed, raised around £55 million, valuing the company at £168m. Altogether, the company has raised £88.6m since the beginning and now has in the region of £50m cash available. Last year it spent almost £7m, but it will probably nearly double that figure this year as it brings its main clinical trial programmes on stream and expenses mount.

Ark came to the Stock Exchange with one product being marketed and a clutch of others in various stages of development, three of them in late stage. On the market, ie, being introduced to UK hospitals and approved to be prescribed on the NHS for patients in the community, but still waiting for a marketing partner for the bigger US market to be announced, is Kerraboot. This is a novel wound dressing for leg and foot ulcers and is claimed to reduce nursing costs and time significantly. The market for leg ulcer dressings, taking the US and Europe combined, is put at $2.7 billion annually with 1.2 million new patients coming in each year, but it is too early to assess how much of the market the company could pick up. One outside estimate suggests it could achieve maximum sales of £300m. A US marketing partner could be announced this year.

The next most important product is Cerepro, a gene-based medicine being developed for treating patients with operable high-grade glioma, a fatal form of brain tumour. Even with the latest approved treatments, most patients die within a year of diagnosis. Recently announced results from a second Phase II efficacy and safety trial confirmed earlier trial results, suggesting that Cerepro, which harnesses healthy brain cells to help prevent a new tumour from growing, gave a significant improvement in survival time after surgical removal of the solid tumour mass. It also appears to be well tolerated and not to bring any deterioration in the quality of life.

Although the extra time gained by the patient is measured in months rather than years, animal testing has suggested repeat doses could offer further benefits. Around 38,000 cases occur each year in Europe and the US.

Commenting on the latest results, Dr Parker said they “support our decision to progress Cerepro’s development to market”, adding: “The study also demonstrates and confirms that first generation vectors can deliver significant therapeutic effects.”
Manufacturing facilities at Kuopio are being expanded and are intended to meet all US and European regulatory requirements. A Phase III trial for Cerepro is expected to start in Europe early next year. Depending on regulatory approval, a launch could come in 2007.

A second late-stage drug is Trinam, a novel gene-based therapy to prevent blood vessels blocking after vascular graft access surgery. The initial target market is haemodialysis access graft surgery for kidney failure patients where a plastic tube is grafted to allow regular blood filtration. Phase II clinical trials are currently under way in America and a report is expected later this year. Trinam is intended to extend the useful life of access grafts and reduce costly repeat procedures. Currently, up to 60 per cent of grafts block within a year of insertion and repeat surgery shows more rapid failure rates. In the US and Europe, Trinam could be useful in an estimated 150,000 cases a year. The company recently announced that Trinam had been granted Orphan Medicinal Product Designation for Europe which would give it marketing exclusivity for ten years after approval. It already had Orphan Designation in the US which would qualify it for a seven year exclusivity period.

Dr Alan Boyd, R&D director for Ark, said the use of Trinam was a novel
concept and the granting of Orphan status was “an important validation of our
science”.

Among its other projects, Ark has Vitor which is being investigated for treatment of severe muscle-wasting weight loss (cachexia) often seen in patients with illnesses such as cancer. Also known as EG006, it could be in Phase III trial this year and, if successful, there could be a European filing in 2005 and marketing in 2006. The US may, it is thought, require a further Phase III trial with possible marketing in 2007. Cachexia is said to affect half of all 3.5 million newly diagnosed cancer cases seen each year in US and European markets. One estimate suggests that Vitor could generate sales of up to £500m.

Also at trial stage are EG005, an oral treatment for the abnormal fat redistribution, which affects some HIV patients, and EG010, a clinical diagnostic test which could eventually rival other in vitro tests to predict the risk of heart attacks. Further behind is a range of pre-clinical research activities.

[BrauchGeld]

Unterbewertet,Superpipeline und eine aussichtsreiche Zukunft !

[BrauchGeld]

[Neoe]

Hi Brauchgeld

Hab gedacht ich hol den Thread mal hoch. Hab den für mich unverständlich großen Rücksetzer zum Einstieg genutzt.

Ark Therapeutics wird innerhalb der nächsten 6 Monate auf der großen Bühne ankommen. Ich nehme Kerraboots, Vitor und Trinam plus die hammermäßige Forschungsabteilung mal aus und beschränke mich bei meinem Enthusiasmus auf CEREPRO:

Erste Gentherapie am Markt, wichtiges Therapieziel, keine Konkurrenz derzeit und die zukünftige Konkurrenz (Neopharma und Xenova) wird es schwer haben ähnliche Effizienz und Nebenwirkungsfreiheit nachzuweisen.

Das multipliziert mit dem Faktor X( Kerraboots, Vitor, etc..) sollte eigentlich für eine Marketcap jenseits der 185 Mio. Euro gut sein.

Deswegen klarer Kauf mit Kursziel von Nomura...

[cyberhai]

Bin jetzt auch investiert, ist sonst noch jemand dabei?

Gruß Cyberhai

[CaveModem [Mod]]

Guten Tag @all

zum Einstellen weiterer Information enthistorisiere ich diesen Thread wieder.

Gruß
CaveModem

[BrauchGeld]

Antwort auf Beitrag Nr.: 16.080.466 von BrauchGeld am 13.03.05 21:25:09

@ CaveModem

Danke fürs aktivieren.

Hallo

Ark Therapeutics steht kurz davor als erstes Unternehmen der Welt (ausser China) ein auf gentechnik basierndes produkt auf den Markt zubringen.
Cerepro wird bei der behandlung von Gehirntumoren eingesetzt bisher mit guten resultaten ,erst am freitag gabs weitere gute nachrichten zu Cerepro wie unten zulesen ist.
Letzte Woche wurde Arkt Therapeutics als Tip des Jahres in der Daily Mail empfohlen.
Neoe und Cyberhai seid ihr noch dabei ? Diese Aktie ist ein muss für jeden Biotechfan wenig risiko aber dafür riesenpotential.

Tip 2007:
http://www.thisismoney.co.uk/investing-and-markets/tips-and-…

Ark Therapeutics is at the forefront. Its pipeline includes Vitor, for weight loss in cancer, and Trinam for kidney patients. Its best prospect is Cerepro, for brain cancer. This could become the first of a new generation of gene-based medicines. Trials suggest a single treatment of Cerepro trebles life expectancy for late stage sufferers.


That only keeps them alive for 12 months, but this might be extended greatly by repeated doses, or adding other treatments.


European drugs regulator EMEA has cleared Ark to produce commercial batches. Full approval could come as early as the first half of 2007. Experts think sales could reach £180m a year or more. At 93¾p Ark is valued at £155m. This month Fidelity bought a 4% stake and took 5.9m warrants. These only pay off if the shares top 140p between 2007 and end-2008 - a remarkable vote of confidence.


Interest in gene research is rising. US giant Merck has just paid £575m for Sirna Therapeutics - more than double its market value. Biotech is risky, but Ark has two years' cash and a highly promising pipeline. Cerepro could transform its prospects - and trigger a bid.

5.1.2007
http://moneyextra.uk-wire.com/cgi-bin/articles/2007010507002…

CereproTM Phase III Trial Progress Update



Patient Recruitment on Track and



Positive Outcome from Latest Independent Data and Safety Monitoring Board Review



January 5 2007 - Ark Therapeutics Group plc (LSE: AKT) ('Ark' or the 'Company)
today provides an update on the Phase III trial (Study 904) being undertaken on
its lead product, CereproTM, for the treatment of high grade glioma (malignant
brain tumour).



The independent Data and Safety Monitoring Board (DSMB) met on December 13th
2006 to review the data from the first 130 patients entered into the trial. Ark
has now been notified by the DSMB that the side effect profile observed to date
in Study 904 is in line with that previously reported, giving the DSMB no cause
for concern nor requiring any alteration in the design and architecture of the
trial. The DSMB has unanimously recommended that the Company continue the study
without modification.



Recruitment into Study 904 has now passed 160 patients, in line with the
Company's previous guidance.



Study 904 is a standard care controlled study to assess the efficacy and safety
of CereproTM in up to 250 patients with high grade glioma. Patients are
randomised in a 1:1 ratio either to standard care alone, or to standard care
plus CereproTM treatment and patients are blinded to the point of treatment
allocation. The multi-centre study is being conducted in Europe and Israel.



Trials completed to date have shown that CereproTM treatment produces an average
extension of 7.5 months of life, giving around 15.5 months survival in a disease
where most patients will only live for around 8 months.



CereproTM is currently undergoing regulatory review for marketing approval with
the European regulatory authority, the EMEA, and the Company expects the review
to be completed around the end of March 2007. CereproTM is the first gene-based
medicine1 to undergo full regulatory review.



The product is manufactured by Ark at its cGMP facility in Finland, which was
granted the first ever commercial gene therapy production licence1 in late 2005.



Dr David Eckland, Head of Research and Development at Ark, said: 'This is very
solid progress, both in terms of patient recruitment into the trial and with the
positive outcome of this latest data review by the DSMB. The fact that
CereproTM is showing a consistent safety profile is further confirmation that
the commercial production and quality standards we have established in Finland
are delivering a reliable and predictable product.'


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

[BrauchGeld]

Antwort auf Beitrag Nr.: 26.749.816 von BrauchGeld am 07.01.07 16:12:59

Laut Piper Jaffray wird Ark im vorfeld der ergebnisse die für März/April erwartet werden weiter steigen !

Fri 09:09 Ark Therapeutics' phase III brain cancer drug trial cleared to continue UPDATE AFX UK Focus
(Adds analyst comment, share price)

LONDON (AFX) - Ark Therapeutics Group PLC's final-stage trial of an experimental drug to treat brain cancer has been cleared to continue without modification, by Europe's medicine safety board.

Cerepro, the company's lead product, is already being assessed by the regulators for marketing approval. Ark said today it expects that review to be completed around the end of March.

The drug, for the treatment of high grade glioma, or malignant brain tumour, is the first gene-based medicine ever to undergo full regulatory scrutiny, outside of China.

It has been shown in an earlier phase II trial to extend life by 7.5 months, giving around 15.5 months survival in a disease where most patients will live for only 8 months.

The independent Data and Safety Monitoring Board (DSMB) met last month to review the data from the first 130 patients entered into the phase III trial. A total of 250 will be needed to complete it, and recruitment has now passed 160, Ark said.

The DSMB found the side-effect profile to be in line with that previously reported.

Because of the lack of effective therapies available to treat the illness, Cerepro has been granted so-called Orphan Drug Status, which can help speed a drug's progress through the regulatory process.

Last month, an Eli Lilly drug targeting a similar disease failed in final stage trials.

The company's joint house broker Piper Jaffray believe the drug could be approved under the "exceptional circumstances" route, especially given other recent failures. They are expecting the EU's decision around the end of the first quarter of the year, or early in the second quarter.

The event would be a major boost for the small-cap drug developer. Piper Jaffray has penciled in sales of 40 mln stg for Cerepro by 2009, if it makes it to the market.

At 8.45 am shares in the company were trading 3.5 pence, or 3.4 pct higher at 106, valuing the company at 176 mln stg.

Piper expects the stock to continue climbing in the next couple of weeks, ahead of a research and development update from the company on Jan 16.

They believe Ark could update investors on end of phase II talks with US regulators on its two other experimental products -- Vitor for muscle wasting in cancer patients, and Trinam, a product which prevents blood vessel thickening in patients who have had surgery after kidney failure.

[cyberhai]

Antwort auf Beitrag Nr.: 26.749.816 von BrauchGeld am 07.01.07 16:12:59

Hallo BrauchGeld,

ich bin noch investiert und hoffe, dass diesmal alles klar geht und die Phase III erfolgreich abgeschlossen wird. Bei Neopharm, welche ebenfalls einen Stoff in Phase III gegen Gehirntumoren hatten, musste ich leider einen 70 %-Verlust verkraften...

Gruß Cyberhai

[BrauchGeld]

Antwort auf Beitrag Nr.: 26.753.549 von cyberhai am 07.01.07 17:44:26

@ Cyberhai

Das tut mir leid für dich, in Neol hätte ich niemals investiert die schwache pipeline und die hohe Marktkap hat mich schon immer abgeschreckt dagegen ist Ark ein traum.

Auf auf und davon :

[BrauchGeld]

Antwort auf Beitrag Nr.: 26.764.624 von BrauchGeld am 08.01.07 10:45:31

Was für eine schöne pipeline, mit knapp 50 mio pfund auf der bank und mit einer marktkap von 182 mio pfund auch sehr niedrig bewertet ,allein Cerepro würde bei erfolg die komplette marktkap decken und bestimmt noch mehr.

Mit Flaminal und Kerraboot (wundheilungsmittel)hat Ark bereits zwei produkte auf dem Markt gebracht.

Products in Development

Cerepro™ (EG009) - a treatment for malignant brain tumours – Phase III

Vitor™ (EG006) - a treatment for cancer related muscle wasting (cachexia) in Phase III

Trinam® (EG004) - a product to prevent blood vessels blocking after vascular graft surgery, in Phase II

EG005 - a treatment for the fat metabolism problem (lipodystrophy syndrome) associated with the most common therapy for HIV positive patients, in Phase II

EG010 - diagnostic kit for cardiovascular risk, measuring oxidised LDL antibodies

EG001 - a bio-degradable device placed around the outside of blood vessels for the localised delivery of therapeutic agents, currently in development as part of the Trinam® project

[BrauchGeld]

Antwort auf Beitrag Nr.: 26.764.888 von BrauchGeld am 08.01.07 11:02:02

Richtig opa es geht aufwärts



http://www.thisismoney.co.uk/investing-and-markets/tips-and-…

Take a tip for 2007

Ark Therapeutics is at the forefront. Its pipeline includes Vitor, for weight loss in cancer, and Trinam for kidney patients. Its best prospect is Cerepro, for brain cancer. This could become the first of a new generation of gene-based medicines. Trials suggest a single treatment of Cerepro trebles life expectancy for late stage sufferers.


That only keeps them alive for 12 months, but this might be extended greatly by repeated doses, or adding other treatments.


European drugs regulator EMEA has cleared Ark to produce commercial batches. Full approval could come as early as the first half of 2007. Experts think sales could reach £180m a year or more. At 93¾p Ark is valued at £155m. This month Fidelity bought a 4% stake and took 5.9m warrants. These only pay off if the shares top 140p between 2007 and end-2008 - a remarkable vote of confidence.


Interest in gene research is rising. US giant Merck has just paid £575m for Sirna Therapeutics - more than double its market value. Biotech is risky, but Ark has two years' cash and a highly promising pipeline. Cerepro could transform its prospects - and trigger a bid.

[BrauchGeld]

Antwort auf Beitrag Nr.: 26.772.347 von BrauchGeld am 08.01.07 17:42:08

Ark ist kurz davor ein neues Jahreshoch(115p) aktuell 113p zu erreichen .

[BrauchGeld]

Antwort auf Beitrag Nr.: 26.785.832 von BrauchGeld am 09.01.07 10:19:08

Wenn es zu einer übernahme kommen sollte dann hoffentlich nur über 200p .

Biotech guru sees more British firms going to U.S.
http://yahoo.reuters.com/news/articlehybrid.aspx?storyID=urn…

[BrauchGeld]

Antwort auf Beitrag Nr.: 26.785.832 von BrauchGeld am 09.01.07 10:19:08

Wahnsinn was da für blöcke über die theke gehen .

[BrauchGeld]

Antwort auf Beitrag Nr.: 26.789.724 von BrauchGeld am 09.01.07 13:18:44

Frankfurter Uniklinikum an internationaler Gentherapiestudie zur Behandlung bösartiger Hirntumore beteiligt
04.10.2006
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]

Antwort auf Beitrag Nr.: 26.808.245 von BrauchGeld am 10.01.07 12:06:36

Wieder sehr gute nachrichten und vorbörslich sieht es auch wunderbar aus.

Ark Therapeutics Group PLC
11 January 2007



Ark Holds Positive End of Phase II Meeting with FDA on Trinam(R) Gene Therapy

Phase II data accepted and FDA offers Special Protocol Assessment for single
pivotal Phase III study


11 January 2007 - Ark Therapeutics Group plc ('Ark') today announces that it has
held a positive 'end of Phase II' meeting with the US Food and Drug
Administration ('FDA') regarding Trinam(R), its novel gene therapy to prevent
blood vessels blocking in kidney dialysis patients who have undergone vascular
access graft surgery.

Key points to emerge from the meeting were that the FDA has agreed that the data
from the Phase II trial, reported by Ark in August 2006, are sufficient to allow
progression to Phase III and a single Phase III trial will be acceptable for the
basis of a marketing approval. Furthermore, the FDA has offered Special
Protocol Assessment (SPA) for the single pivotal Phase III study for Trinam(R).
The SPA procedure allows Ark to work directly with the FDA to ensure the design
of the trial, the definitive clinical objectives and data analyses are optimised
to support regulatory approval.

The Phase III study is being planned as a multi-centre, randomised, controlled
trial of up to 250 patients in which the efficacy and safety of Trinam(R) 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(R) 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. The primary endpoint of the trial will be the time to graft
failure.

Ark reported the preliminary results of the ongoing, open-label, standard-care
controlled Phase II trial in August, with the new data from the trial showing
that the access grafts of low dose patients remained functional for dialysis on
average over five times longer (17.8 months) than control patients in the trial
(3.3 months). At that time, in the high dose group, recruited after the low
dose group, all patients with successful graft implants had open grafts with
patency averaging 8 months. For the primary end point of safety, no
quantifiable systemic distribution of Trinam(R) was found in either of the high
or low dose groups and the product is well tolerated. No serious side effects
were exhibited other than those consistent with the nature of the operation and
condition.

As part of the overall Trinam(R) programme, Ark also announces today that, after
consultation with the FDA, it intends to undertake a small pre-clinical study on
Trinam(R), investigating biodistribution in an 'end-to-side' procedure for
surgical placement of the graft. If the results of this trial are in line with
expectations, it will allow the Phase III trial to include this procedure
alongside the 'end-to-end' placement procedure. Pending SPA agreement, the
Phase III study is expected to commence around mid-2007 and to last for
approximately 18 months.

Commenting on today's announcement, Dr Nigel Parker, Chief Executive of Ark,
said:

'The FDA's positive response to the next stage of Trinam(R)'s development,
particularly its offer of Special Protocol Assessment, confirms our belief in
the future of this product. We have very encouraging Phase II data on the
clinical effectiveness of Trinam(R) and believe that Trinam(R) may have a
valuable role to play in the treatment of kidney failure patients where the
problem of vascular access blocking is identified in the US Healthy People 2010
Framework as one of the key medical issues to be resolved. This outcome is in
line with our budgeted plan and we look forward to giving a further update after
receiving Special Protocol Assessment and to the commencement of the Phase III
study.'

[BrauchGeld]

Antwort auf Beitrag Nr.: 26.825.105 von BrauchGeld am 11.01.07 09:11:32

arkkkkk fliegtttttt

[BrauchGeld]

Antwort auf Beitrag Nr.: 16.080.466 von BrauchGeld am 13.03.05 21:25:09

Als nächstes steht die zulassung für Cerepro an im 1Q oder anfang 2Q 2007 !

[BrauchGeld]

Antwort auf Beitrag Nr.: 26.827.633 von BrauchGeld am 11.01.07 11:29:09

Ark alias Boing 747 kennt kein halten mehr

[BrauchGeld]

Antwort auf Beitrag Nr.: 26.837.150 von BrauchGeld am 11.01.07 17:40:09

The Independent empfiehlt Ark Therapeutics

Was mir sehr gefällt :
Fund management giant Fidelity recently invested in the company and currently holds a 4 per cent stake. It has also been given warrants to buy further shares at 140p which highlights their belief the stock has considerably further to go.

Ark Therapeutics

Our view: Worth a punt

Share price: 132p (+13.25p)

Ark Therapeutics is leading the way in gene therapy. The healthcare company specialises in vascular disease, wound care and cancer - all growing markets with opportunities for new products to generate high rewards.

Ark's treatment for brain cancer, Cerepro, which is in final stage trials, has no competitors and is set to be the first gene-based therapy medicine on the market outside China. The company also recently signed a series of marketing deals for its wound dressing Kerraboot.

Its other key product, Trinam, is now also about to enter phase-three trials following a better-than-expected meeting with the US Food and Drug Administration on its second-stage trials. The FDA ruled that the drug will now only need a single phase-three trial - relatively small with around 250 patients - before it heads for market approval.

Trinam is a therapy designed to prevent blood vessels blocking in kidney dialysis patients who have undergone surgery. If all goes well it could reach the market in late 2009 and analysts are forecasting potential sales of £450m.

Shares surged 11 per cent - up 13.25p to 132p - yesterday on the back of the announcement, leaving the company with a market valuation of around £220m.

Fund management giant Fidelity recently invested in the company and currently holds a 4 per cent stake. It has also been given warrants to buy further shares at 140p which highlights their belief the stock has considerably further to go.

With approval of Cerepro scheduled for spring this year and further upside expected from Trinam, it's worth a punt.

[BrauchGeld]

Ark notiert nur noch ganz knapp unter IPO kurs:

[BrauchGeld]

Antwort auf Beitrag Nr.: 26.857.746 von BrauchGeld am 12.01.07 13:11:32

Credit Suisse also issued a new note on AKT after the recent R&D day -highlights for me were

1) Price target 200p based on a DCF valuation
2) They think that the chances of Cerepro getting early approval are 50:50 (price target assumes it does not get approval)
3) Cerepro and trinam may have other applications
4) Preclinical products are interesting but have no attributable value



http://www.telegraph.co.uk/money/main.jhtml?xml=/money/2007/…

Investment in science is a hard cell
Last Updated: 11:51pm GMT 20/01/2007

Sylvia Pfeifer looks at why business and genetics are not always a natural pairing

Remember Dolly the sheep? The world's first cloned mammal was heralded as a scientific breakthrough and helped establish Britain's reputation as home to a thriving biotechnology industry. Today, 10 years after she was created, Dolly is stuffed and on display at the Royal Museum in Edinburgh.

Although Dolly was mainly a scientific sensation, it was also a story about business. At the height of Dolly's fame, shares in PPL Therapeutics, the Scottish company that created her, were worth more than 450p. The company eventually collapsed in 2004, its cutting-edge expertise sold to an American group.

advertisementA decade after Dolly was created, British geneticists are once again making headlines: this time, with the creation of a breed of genetically modified hens that can produce cancer-fighting medicines in their eggs. The 500-strong flock was bred at Edinburgh's Roslin Institute, the birthplace of Dolly. Scientists believe the breakthrough could lead to treatments for Parkinson's disease, diabetes and a range of cancers.

Just as investors piled into PPL, there will be others keen to take a punt on those companies that follow in its footsteps. But can breakthrough research ever generate breakthrough returns for investors? Simon Best, the chairman of the BioIndustry Association, is among those who are adamant that the two can go hand in hand. What investors need to accept, he argues, is the time it takes to get a commercial product to the market. "There is always going to be a huge time lag between cutting-edge research and the commercial product. At the beginning of the biotech industry, people thought it would dramatically alter the time horizons, but it didn't," he says.

The other factor is cost. Even those that run the companies active in new areas of research such as gene therapy or stem cells concede you will always need more capital than you initially thought. "If you do cutting-edge anything, because it's such a step into the unknown, there will always be a huge attrition of funds," says Nigel Parker, the chief executive of Ark Therapeutics, which is working on a gene-based brain cancer medicine.

Michael Hunt, his counterpart at ReNeuron, which is working on treatments for brain damage caused by strokes and Alzheimer's disease using stem cells, is even more categoric about the risks. "How is the value created in cutting-edge science?" he asks. "With very great difficulty. It is high-risk, high-return. In the stem cell field, it applies to more than most."

Hunt knows what he is talking about. The company initially floated in November 2000 with a valuation of £65m. The shares subsequently collapsed after it discovered that its manufacturing process created unstable stem cells that divided too often and became impossible to control. Its private equity backer, Merlin Biosciences, run by Sir Christopher Evans, eventually took it private for just £3.6m in April 2003 – less than the £5m-£6m cash ReNeuron still had on its balance sheet.

Two years later, the company returned to the public markets. But even in the intervening two years, it has not all been plain sailing. Earlier this month, ReNeuron's shares lost a fifth of their value to 36.5p after the US medicines regulator, the US Food and Drug Administration, placed the company's application to conduct clinical trials of its stroke treatment on hold. The shares have since ticked up to close at 42.5p on Friday.

Hunt is sanguine about the decision, arguing that it is part and parcel of being a company operating within a new area. "The FDA decision was not unexpected," he says. "There is no precedent for what we are doing. Ultimately, we believe we will get there, delivering cell therapy products to patients."

If there is one rule for investors in these companies, it is that there are no rules.

Even Merlin, one of the industry's leading venture capital investors, has not always backed the right horse. But while it may still be waiting to hit the big time with ReNeuron, other investments, such as the one in Ark, have already paid dividends.

Earlier this month, the company announced that its potentially life-saving treatment for brain tumours, Cerepro, may be given early approval to be put on the market in Europe by March. Trials of Cerepro so far have shown one dose can give a patient with malignant brain cancer an extra seven and a half months of good quality life. Those with the condition normally have eight to nine mainly painful months to live.

But while a venture capital investor like Merlin can afford to wait up to 10 years before seeing a return on investments, the time horizons of institutional investors are traditionally much shorter. Nevertheless, there are some that do decide to take the plunge. Just before Christmas, for example, Fidelity, the blue-chip fund manager, took just under a 4 per cent stake in Ark.

One of the reasons gene therapy companies such as Ark and Oxford BioMedica, which is developing a gene therapy drug against renal cancer, are exciting both scientists and investors is that many believe gene therapy could be the next technological platform after monoclonal antibodies to produce commercial products.

Erling Refsum, director at merchant bank Mulier Capital, says: "Since Crick and Watson discovered DNA, it has been all about what the blueprint does. Up to now, we've been trying to produce chemicals that block or mimic the chemicals that genes make. The next stage will be medicines that turn genes on or off."

"New technologies generally take 30 years to be a big commercial success. We're getting into that time period now for gene therapy," he adds.

Other technologies, such as stem cells or indeed pharming – which involves the use of animals that have been genetically modified to produce human proteins in their milk – will take longer to deliver commercial successes. Pharming, for example, the Netherlands-based company, produces therapeutic proteins derived from the milk of transgenic animals.

For stem cells, the current issues are twofold, says David Macauley, the chief executive of the UK Stem Cell Foundation: intellectual property and the business model. There has been a huge escalation in patenting around the world, raising concerns about the freedom to operate. Second, there is a great uncertainty regarding the product and its delivery.

Professor Alan Kingsman, the CEO of Oxford BioMedica, raises the same problems.

"The big issue is: there isn't a product, it's more a service. It's a very different thing from a pharmaceutical in a bottle," he says.

What the Government needs to do is take a more hands-on approach and create the regulatory context that will promote investment into the area, argues Macauley.

"The UK leads the world in terms of capability in stem cells, but we're probably the least equipped to exploit that, thanks to things like risk aversion and the structure of our financial markets," he says. "Once we've got proof of principle, I think the commercial money will flow."

So what lessons have people drawn from the short life of Dolly? If there is one, it is that scientists need to think about what technologies are going to find a market and which aren't.

"The problem with the whole transgenic animal was that scientifically, it was an interesting idea, but from a real-world perspective, there was not a lot of demand for it," says Kingsman.

That is, at least, not yet.

[BrauchGeld]

Alles läuft wunderbar bei Ark fehlt nur noch die zulassung für Cerepro als krönung .

Ark Therapeutics Group PLC 16 February 2007

Positive outcome from pre-Phase III FDA and EMEA scientific advice meetings for
VitorTM
Phase III trial scheduled to commence in H2 2007


16 February 2007 - Ark Therapeutics Group plc ("Ark" or the "Company") today announces that it has held positive pre-Phase III scientific advice meetings with the US Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA) regarding VitorTM, an oral therapy in development for treating the weight loss and muscle wasting (cachexia) associated with cancer.

The regulatory agencies reviewed the VitorTM data package, including results from the Phase II/III trial completed in 2006 (a first to man study in cachexia) and the Company's proposed Phase III study protocol. Key points to emerge from the meetings were that the existing data are sufficient to allow Ark to optimise the study design and architecture and to commence Phase III clinical development. The possibility exists for an approval based either on treating weight loss or on improving clinically relevant functional measurements such as muscle strength. VitorTM has been awarded Fast Track status by the FDA and the Company expects to finalise the design of the study during the FDA Special Protocol Assessment (SPA) process.

The Phase III study is planned as a multi-centre, randomised, placebo controlled trial of up to 250 patients, in which the efficacy and safety of VitorTM will be investigated in non-small cell lung (NSCL) cancer patients with cachexia. The study will be of 16 weeks in duration. To avoid study entry effects, the first four weeks will be a 'lead in' to confirm weight loss is actually occurring in the entered patients, after which they will be randomised into the study. The rate of weight loss will be measured, as well as key functional and clinically relevant quality of life markers. The study is anticipated to take about 18 months to complete and will be conducted in both the USA and Europe. The trial is scheduled to commence in Q3 2007, after protocol assessment has been completed. Final protocol details will be announced at that time.

Commenting on today's announcement, Dr Nigel Parker, Chief Executive of Ark, said:

"The outcome of these latest meetings with the regulatory agencies in the US and Europe is further good news for Ark. We now have three products at the Phase III development stage which gives us one of the strongest late stage pipelines in the small cap biotechnology sector. In addition, it demonstrates the strategy and value of our business model, spreading risk across a number of independent products in development."

[BrauchGeld]

Antwort auf Beitrag Nr.: 27.740.299 von BrauchGeld am 16.02.07 09:49:13

Die Zulassung rückt immer näher .......

Cerepro, the company\'s lead product, is already being assessed by the regulators for marketing approval. Ark said today it expects that review to be completed around the end of March.

The drug, for the treatment of high grade glioma, or malignant brain tumour, is the first gene-based medicine ever to undergo full regulatory scrutiny, outside of China.

It has been shown in an earlier phase II trial to extend life by 7.5 months, giving around 15.5 months survival in a disease where most patients will live for only 8 months.

3M Chart:

[BrauchGeld]

Antwort auf Beitrag Nr.: 27.825.293 von BrauchGeld am 19.02.07 15:17:33

Ark Therapeutics ist defenitiv eines der besten Biotechs und weltweit führend in der gentherapie.
Ark Therapeutics steht kurz davor als erstes Unternehmen der Welt (ausser China) ein auf gentherapie basierndes produkt auf dem Markt zubringen.

Marktkap: 326 mio€
Cash: 71 mio€

Products in Development

Kerraboot (Wound Management) Foot and leg ulcers - approved and launched

Cerepro™ (sitimagene ceradenovec) - a treatment for malignant brain tumours – Phase III completed

Vitor™ (EG006) - a treatment for cancer related muscle wasting (cachexia) in Phase III

Trinam® (EG004) - a product to prevent blood vessels blocking after vascular graft surgery, in Phase III

EG005 - a treatment for the fat metabolism problem (lipodystrophy syndrome) associated with the most common therapy for HIV positive patients, in Phase II

EG010 - diagnostic kit for cardiovascular risk, measuring oxidised LDL antibodies

EG001 - a bio-degradable device placed around the outside of blood vessels for the localised delivery of therapeutic agents, currently in development as part of the Trinam® project

[BrauchGeld]

Antwort auf Beitrag Nr.: 27.835.940 von BrauchGeld am 19.02.07 21:12:32

Ark ist nach der kleinen pause wieder auf kurs neue hochs zu erklimmen.

[BrauchGeld]

Antwort auf Beitrag Nr.: 27.846.877 von BrauchGeld am 20.02.07 13:38:46

Einfach schön anzusehen wie meine Ark steigt

Ark Therapeutics Group PLC 22 February 2007


Ark wins key patent case on stroke in Europe


London, UK 22 February 2007 - Ark Therapeutics Group plc ("Ark" or the "Company") announces that following a hearing at the European Patent Office (EPO) it has been informed by its patent attorneys, Gill Jennings & Every LLP, that it has been successful in prosecuting Ark's patent application relating to its intellectual property concerning the use of agents that affect the angiotensin-renin system for the prevention and treatment of stroke.

The patent will cover 23 molecules belonging to the therapeutic classes of angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor (ATII) blockers, many of which are already marketed for various indications. The geographic scope of the patent comprises the 18 European countries that belonged to the European Patent Convention in 1998. The European patent will give protection in the applicable European countries until 2018. Separate patent applications are under prosecution in the USA as well as in other international territories.

In April 2005, Ark signed a licence agreement with Boehringer Ingelheim granting rights to Ark's intellectual property for the use of its products affecting the renin-angiotensin system. The deal comprised upfront and milestone payments and undisclosed royalties on sales of Boehringer Ingelheim's products for the indication of stroke in all territories in which Ark has secured patent protection. Formal grant of this European patent will trigger a milestone payment from Boehringer Ingelheim to Ark. Further financial details have not been disclosed.

Dr Nigel Parker, CEO of Ark, commented: "We are very pleased to announce this important patent news. The mitochondrial2 science on which the patent is based was an exciting very early discovery by Ark scientists and we are pleased to see the novelty being recognised by the European Patent Office in this third therapeutic application. Ark will now start to consider the further commercial licensing potential of the patent."

[BrauchGeld]

Antwort auf Beitrag Nr.: 27.892.346 von BrauchGeld am 22.02.07 10:26:50

Mit Zulassung könnte sich die Aktie noch mehr als verdoppeln also beten das es klappt .

[BrauchGeld]

Antwort auf Beitrag Nr.: 27.892.635 von BrauchGeld am 22.02.07 10:39:30

Ark streckt seine fangarme immer weiter aus .

3M Chart:


LONDON, Feb 22 (Reuters) - Shares in Britain's Ark Therapeutics Plc (AKT.L: Quote, Profile , Research) jumped on Thursday after the company said it had won a European patent for the use of a broad class of drugs known as ACE inhibitors for the treatment of stroke.

At 1110 GMT shares in the company were up 15.6 percent at 155-3/4 pence, valuing the company at 223.6 million pounds ($437 million).

Ark said the patent, valid until 2018, covers a group of 23 ACE inhibitors, widely marketed to control blood pressure and risk of other cardiovascular conditions, including stroke.


"Ark will now start to consider the further commercial licensing potential of the patent," Chief Executive Nigel Parker said in a statement.

The London-based company said it had already signed a licence agreement with Boehringer Ingelheim (BI) for the use of ACE inhibitors in the development of a stroke treatment.

The deal, which Investec estimates was worth around 19 pence of the company's valuation, included upfront payments and royalties on sales of BI's products in all territories in which Ark has secured patent protection.

Investec analyst Ibraheem Mahmood said any pharmaceutical company which uses ACE inhibitors, which generate billions of dollars of revenues, will in future have to compensate Ark for the right to use the drug. Continued...

We expect Ark to now "go knocking on the door" of all pharmaceutical companies with stroke programmes using ACE inhibitors and each time it cuts a deal we will increase our DCF (discounted cash flow) valuation," Mahmood said.

"Patents are key to a biotech company strategy, but typically are not valued by the market as they have commercial value only far into the future -- in this case this win has direct commercial value applicable today."

Ark said it had already filed a separate patent application in the United States and other international territories.

[BrauchGeld]

Ark hat genug geld besitzt eine verdammt heiße pipeline und ist trotz anstieg immer noch sehr günstig bewertet .
Das Unternehmen steht vor dem durchbruch,erhält Cerepro die zulassung wäre es das erste Gen-Medikament der Welt (ausser China).

Cerepro verdoppelt fast die überlebenszeit bei Gehirnkrebs
http://www.arktherapeutics.com/main/products.php?content=pro…

Marktkap: 224 mio pfund (330 mio€)
Cash: 48,4 mio pfund (71,3 mio€)

Products in Development

Cerepro™ (sitimagene ceradenovec) - a treatment for malignant brain tumours – Phase III completed

Vitor™ (EG006) - a treatment for cancer related muscle wasting (cachexia) in Phase III

Trinam® (EG004) - a product to prevent blood vessels blocking after vascular graft surgery, in Phase III

EG005 - a treatment for the fat metabolism problem (lipodystrophy syndrome) associated with the most common therapy for HIV positive patients, in Phase II


Kam Patel, 07/03/07 14:42

Biotech minnow Ark Therapeutics posted wider full year losses but all eyes are on its brain cancer treatment Cerepro, with European regulators set to decide whether to give it the go-ahead soon.
Full year pretax losses widened to £19.1m from £16.77m on revenue of £344,000, down from £2.35m. The increased loss reflects investment in its last stage products and a new manufacturing facility and the timing of milestone receipts under the licensing agreement with Boehringer Ingelheim.


The agreement with Boehringer was signed in 2005 and relates to Ark intellectual property concerning the use of agents to aide prevention and treatment of stroke. In 2005 the agreement was worth £2m to Ark and further receipts are due over 2007.


R&D spend eased a little to £12.8m from £13.9m. After share placing that raised £34m during the year, the group ended the period with a cash position of £48.4m versus £34.3m last time. Brett Pollard, analyst at Numis reckons that at the current burn rate, that is enough to keep the company going for 2.5 years.


Result aside, it is, Manchester United manager Alex Ferguson might say, squeaky bum time for Ark investors. The company now has two products on the market but the big focus for substantial upside is its promising, late stage portfolio, comprising three drugs in the Phase III development stage.


The most important and potentially valuable is the brain cancer treatment Cerepro, which is currently being assessed by the European Medicines Regulatory Authority, EMEA. A decision is expected over Ark's first half to June, and any time after the end of March.


If the review of the application by EMEA is successful, Cerepro will become the world's first gene therapy product. The very fact that it is so novel, however, means EMEA may ask for more data, something Ark should be able to provide pretty quick as through its quickly established ongoing Phase III/IV corroborative study for the drug.


Pollard at Numis, reckons Cerepro could be worth around £300m a year for the group, assuming its full penetration worldwide.


Elsewhere across its late stage portfolio there is Vitor, an oral therapy for treating the weight loss and muscle wasting (cachexia) associated with cancer. It is due to enter Phase III trials in the third quarter. Also heading into Phase III trials is Trinam, for use in kidney failure.


Pollard says Cerepro is 'by far the most important and valuable' of the three late products. Its approval from the EMEA would be 'a major catalyst for this stock', he adds.


Ark Therapeutics Plc shares started calendar 2007 on a very perky note, with approval of final stage trials for Cerepro by EMEA in early January providing a big boost. The shares powered ahead more than 50% from the start of the year to an all-time high of 152p in late February. Since they, however, have lost some ground as nervousness over the EMEA's looming decision on the treatment triggered profit taking.


Pollard maintains his target price of 138p but says that if Cerepro manages to gain early approval, his target price would adjust to around 180p.


In the wake of the statement, Ark Therapeutics Group Plc shares rose 1.225p to 132.75p, valuing the company at £220m.

[BrauchGeld]

Ark hat keine vorzeitige zulassung auf basis der Phase 2 daten für Cerepro erhalten grund ist die geringe anzahl der patienten ,aber keine sorge Ark hat vor kurzem Phase 3 mit 250 patienten abgeschlossen daten folgen in kürze deshalb gings auch aufwärts mit der Aktie.


Ark Therapeutics' cancer drug Cerepro cannot be approved 'yet' in Europe UPDATE

LONDON (Thomson Financial) - European medicine regulators have told Ark Therapeutics Group PLC that its lead experimental brain cancer drug Cerepro cannot yet be given marketing approval, dashing hopes of an early launch.

In a statement, Ark said it understands that the European medicines regulatory authority (EMEA) has taken the view that there is not yet sufficient clinical evidence to prove the risk benefit for patients beyond doubt.

Detailed feedback has not yet been received.

The news, while disappointing, will not a huge surprise.

Regulators accepted Cerepro for review with less data than is normally required, from small phase II trials involving only 24 patients, because of the lack of effective therapies available to treat the illness.

As a result, company followers viewed the chances of the drug getting a green light so early as fairly slim.

The group's chief executive Dr Nigel Parker told Thomson Financial News last month that he believed the therapy had a 50 pct chance of being granted a marketing licence straight off.

Still, Ark shares were trading 4.7 pct, or 6 pence lower at 123 at 8.20 am. The stock has gained 38 pct this year, largely amid hopes of an early approval.

Cerepro, a gene-based therapy, is in trials as a treatment for high-grade glioma, a rare form of malignant brain tumour, and has been granted so-called "Orphan Drug Status".

The drug is injected into the brain after a tumour has been removed, harnesses healthy brain cells to help prevent a new tumour from growing.

In phase II trials the drug was found to extend life by 7.5 months, giving around 15.5 months' survival for a disease where most patients live for only 8 months.

Earlier this week, the company announced it had completed recruiting 250 patients into a phase III trial of the drug.

Ark said today it will decide how to progress the regulator's approval process when it receives detailed feedback. The EMEA's concerns may be able to be resolved through the provision of further data or analyses from the existing Phase II trials, or new data may be required from the larger ongoing Phase III study, it said.

Cerepro is manufactured by Ark in its facility in Finland, the first facility ever to be approved to manufacture gene-based medicines for commercial supply in Europe.

"Early approval would have been welcome upside news but the major successes in clearing manufacturing, preclinical and environmental sections of the filing are huge regulatory steps forward for Cerepro and for the prospects of gene-based medicines in Europe," CEO Parker said in a statement today.

-----------------------------------------------------------------

Ark Therapeutics Group plc
Phase III CereproTM Study Completes Recruitment


24 April 2007, London UK: Ark Therapeutics Group plc ("Ark" or the "Company") today announces that it has completed recruitment into the Phase III trial (Study 904) for CereproTM, its novel gene-based medicine for the treatment of operable high grade glioma (malignant brain tumour).

Study 904 is a standard care-controlled study to assess the efficacy and safety of CereproTM in 250 patients with high grade glioma. Patients are randomised in a 1:1 ratio, either to standard care alone, or to standard care plus CereproTM and patients are blinded to the point of treatment allocation. The multi-centre study is being conducted in Europe and Israel.

Clinical trials completed to date have shown that CereproTM treatment produces an average extension of 7.5 months of life, giving around 15.5 months survival in a disease where most patients will only live for around 8 months.

CereproTM has Orphan Drug Status in Europe and the USA. It is manufactured by Ark in its facility in Finland, the first facility ever to be approved to manufacture gene-based medicines for commercial supply in Europe.

CereproTM is currently undergoing regulatory review for early marketing approval with the European regulatory authority (EMEA), based on the data from already completed Phase II trials. The Company expects the review to be completed shortly.

Nigel Parker, Chief Executive of Ark, commented:

"Completion of recruitment into this Phase III study is a key milestone for CereproTM and we are pleased to report this news according to plan. The increasingly rapid recruitment into this trial has been very encouraging and reflects the enthusiasm amongst neurosurgeons for this much-needed product and the growing appeal of gene-based therapies. CereproTM has previously demonstrated that it is able almost to double average patient survival time offering significant hope to patients who develop malignant glioma. It is also the first gene-based medicine1 to undergo full regulatory review and we look forward to updating investors on the outcome of the EMEA's review in the near future."

[BrauchGeld]

Ark ist eines der besten Biotechs weit und breit.........


Ark Therapeutics Group plc


Ark commences clearance process for Trinam(R) Phase III trial with US
Recombinant DNA Advisory Committee application


2 May 2007, London, UK: Ark Therapeutics Group plc announces that it has filed its application to the US Recombinant DNA Advisory Committee (RAC) to obtain clearance for its planned Phase III US clinical study of Trinam(R), Ark's novel gene-based therapy to prevent haemodialysis access graft blockage.

The RAC is expected to make a decision by the end of its meeting scheduled for 19-21 June. Ark has previously obtained clearance for a 200+ patient study of Trinam(R) from the RAC and this new application reflects the revised architecture following the successful end of Phase II meeting with the FDA, announced on 11 January 2007.

Commenting on the announcement Ark's CEO, Dr Nigel Parker, said:

"This is an important stage in the clearance process to allow us to commence Trinam(R)'s pivotal Phase III study. RAC hearings are held in public and it is important that as development progress is made with such new DNA-based medicines the public has the opportunity to comment. The RAC is an independent body to the FDA and we need to obtain this clearance alongside our work with the FDA. Trinam(R) continues to progress well and we look forward to giving further updates in due course."

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 Anna Keeble

Notes to Editors

Trinam(R)

Trinam(R) 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.

Trinam(R) has undergone a Phase II clinical study, which has shown encouraging early efficacy results, with grafts of treated patients remaining functional for dialysis on average between two and four times longer than controls. For the primary end point of safety, no quantifiable systemic distribution of Trinam(R) was found and the product is well tolerated. No serious side effects were exhibited other than those consistent with the nature of the operation and condition.

After consultation with the FDA in January 2007 Ark announced that it intended to undertake a small pre-clinical study on Trinam(R), investigating biodistribution in an "end-to-side" procedure for surgical placement of the graft. If the results of this study are in line with expectations, it will allow the Phase III trial to include this procedure alongside the "end-to-end" placement procedure. Pending SPA agreement, the Phase III study is expected to commence around mid-2007 and to last for approximately 18 months.

The Phase III study is being planned as a multi-centre, randomised, controlled trial of up to 250 patients in which the efficacy and safety of Trinam(R) 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(R) in addition to standard care or standard care alone at the time of surgical placement of a synthetic PTFE graft for vascular access. The primary endpoint of the trial will be the time to graft failure.

Recombinant DNA Advisory Committee

The US National Institutes of Health (NIH) established the RAC on October 7, 1974 in response to public concerns regarding the safety of manipulating genetic material through the use of recombinant DNA techniques. Although the RAC's membership and responsibilities have evolved over time with scientific understanding and developments in this technology, it continues to serve the NIH, as well as the scientific and lay publics, as a critically important forum for open, public deliberation on the panoply of scientific, ethical, and legal issues raised by recombinant DNA technology and its basic and clinical research applications. Over the course of the Committee's existence, transparency and access have been its defining characteristics, enabling public acceptance of a critically important technology and creating an environment in which science can advance in an informed, safe, and ethical manner.

The RAC comprises experts in a wide range of scientific and medical disciplines and also includes ethicists and members of patient and other lay communities. Because of the dedication, effort, and thoughtful contributions of its members over the past 30 years, the RAC has been a vital national forum promoting critically important scientific progress in a transparent, responsible, and safe manner and enhancing public trust in the science.

[BrauchGeld]

Ich mag dieses Unternehmen sehrrrrr.......

Ark Therapeutics Group PLC 22 May 2007


Ark Therapeutics Group plc


US Recombinant DNA Advisory Committee gives early clearance for Trinam(R) Phase
III trial


22 May 2007, London, UK: Ark Therapeutics Group plc announces today that it has been given clearance by the US Recombinant DNA Advisory Committee (RAC) for its planned Phase III US clinical study of Trinam(R), Ark's novel gene-based therapy to prevent haemodialysis access graft blockage.

Ark filed its application to the RAC earlier this month and a final decision had been expected by the end of the RAC's public review process scheduled for 19-21 June. After the initial review, the RAC members have determined that the application does not require further review and discussion in a public session and has therefore given clearance for the product to commence the 200+ patient pivotal Phase III study. The Company will now undergo Special Protocol Assessment (SPA) for the Phase III study with the FDA and the trial is expected to commence in the second half of 2007 once this is complete.

Commenting on the announcement Ark's CEO, Dr Nigel Parker, said:

"The rapid granting of this approval without the need for a public hearing illustrates just how far gene-based medicine has advanced in the last year or
two. We look forward to giving further updates on the SPA process in due


course."

[BrauchGeld]

Ark Therapeutics Group PLC 31 May 2007


New study shows Scavidin(R) is effective in slowing tumour development and improving survival time

Demonstrates potential of Ark's unique DNA-based targeting technology to reduce side effects and increase efficacy of chemotherapy and other pharmaceuticals

London, UK, 31 May 2007: Ark Therapeutics Group plc announces today that its novel gene-based drug targeting platform technology, Scavidin(R), has shown further pre-clinical evidence of being highly effective in slowing tumour development and significantly improving survival time using a low dose of the radiotherapy Yttrium90 which would be sub-therapeutic if administered conventionally.

Scavidin(R) was used to target and concentrate intravenous doses of approximately one-fifth the conventional levels of the radioisotope Yttrium90 in a model of malignant glioma, a particularly aggressive and fatal form of brain tumour. In the model, the treatment group survived 32% longer on average (p< 0.0001) than those given Yttrium90 without Scavidin(R) or untreated controls. Scavidin(R) DNA was transfected into the brain tumours using a viral vector. Biotin-tagged Yttrium90 was given intravenously at a sub-therapeutic dose. Yttrium90without Scavidin(R) was used as the treatment control. Only where Scavidin(R) had been transfected was an improvement in survival observed. No major side-effects were observed.

In February 2006 Ark announced its initial evidence of effective tumour control with between a fifth and a tenth of the conventional doses of Yttrium90 and paclitaxel in cancer models of tumour growing under the skin. The results today provide further evidence of the potential wide utility for this leading edge technology in very large markets.

Ark will now continue to optimise the vector and dosing regimes and explore the full concentration gradient capabilities of Scavidin(R). It will also continue pre-clinical toxicity work prior to commencing clinical studies after consulting with the regulators.

Nigel Parker, CEO of Ark, commented:

"Our previous model results had shown effective tumour control and now this third model has shown this translates into improved survival time at an Yttrium90 dose which, if used conventionally, would have no effect. Scavidin(R) has the potential to improve the therapeutic effect and reduce the unpleasant side-effects of a wide variety of drugs, most obviously chemotherapy and other potent anti-cancer agents, but also in many other therapies where the side-effects are high and thus dose-limiting."

Dr David Eckland, Ark's Research and Development Director,,added:

"Scavidin(R) targeting technology offers the possibility of cancer patients being given up to a 10 times lower dose of an anti-cancer drug than in conventional treatment approaches. This could markedly reduce side-effects such as hair loss and vomiting and enable the treatment to be repeated more easily. It also allows the anti-cancer drug to be concentrated into the tumour at higher levels and thus its biological 'cancer cell killing' efficacy can be very substantially increased."

[BrauchGeld]

Ark Therapeutics Group PLC 07 June 2007


Ark strengthens wound care portfolio with third product Kerraped(R)


Pricing agreed with NHS Business Services Authority with UK launch scheduled for


Q3

London, UK, 7 June 2007 - Ark Therapeutics Group plc ("Ark") today announces that its subsidiary, Patient Plus Limited, has signed an exclusive licensing agreement with Darco GmbH & Co., a manufacturer of surgical, trauma and wound care products, in respect of the UK and international marketing rights for a Darco proprietary medical footwear device for the management of diabetic foot ulcer patients. The device will be marketed by Ark under the Ark brand of Kerraped(R). Ark also announces today that it has successfully achieved pricing re-imbursement from the UK NHS Business Services Authority for Kerraped(R), making it the first product of its class to be available to the NHS on prescription.

Under the terms of the licensing agreement, Darco will manufacture and supply the product at an agreed transfer price to Ark, who will be responsible for reimbursement and conducting all sales and marketing activities. Ark will launch an all purpose boot (APB) and a more lightweight shoe version of Kerraped (R) after their listing in the Drug Tariff Guide in a new category to be called 'Plantar Pressure Offloading Devices', currently expected in August, at a price of #16.63 and #12.57 respectively.

Ark's existing UK sales force, which currently markets Kerraboot(R), a novel microclimate dressing device for diabetic and venous leg ulcers, and Flaminal (R), an antimicrobial gel for infected wounds, will be used to promote Kerraped (R). The two Kerraped(R) variants will have wide utility being suitable for all patients who need to reduce plantar pressure (pressure on vulnerable areas of the sole of the foot). Kerraped(R) can be used with Ark's Kerraboot(R) and will improve patients' mobility as well as providing further protection to the wound. Ark's existing international Kerraboot(R) licensees will be offered the local distribution rights to Kerraped(R) where appropriate.

A recent audit of Primary Care Trusts in the UK1 has shown that the absence of the availability of properly designed medical footwear in the community results in 66% of patients wearing footwear which is inappropriate for their condition. This results in a significantly higher rate of foot ulcer recurrence, particularly in the diabetic community, as well as a significantly increased number of falls. Kerraped(R) has been shown to reduce plantar pressure by up to 30%2 and does not need to be customised to achieve this pressure reduction. Unlike other products, Kerraped(R) can be prescribed by primary healthcare professionals without additional training and product customisation.

Kerraped(R)'s inclusion in the Drug Tariff as the first in a new class is driven by its potential to offer significant cost savings to the NHS. With diabetic foot ulcers alone, the cost of treatment to the NHS is currently estimated at around #500m per annum. Net cost savings to the NHS of up to #90 million could be possible, as clinical data so far has shown that medical footwear providing proper offloading characteristics can keep diabetic patients' feet ulcer-free for up to three times longer and reduce relapse rates overall by 50%3.

Nigel Parker, CEO of Ark, commented:

"Such specialist footwear has historically only been available in hospitals where its biomechanical characteristics have been well recognised by specialists as providing benefits to healing ulcers and preventing recurrence. As the number of patients with diabetes increases, the NHS is coming under mounting pressure to offer an effective treatment to patients beyond the hospital setting. Kerraped(R) will be available now to the whole community and will give all patients the mechanical offloading they need at a very cost effective price.

This agreement with Darco represents another development in our long-term strategy of building a stand-alone wound care and devices division and allows us to leverage our UK sales infrastructure for Kerraboot(R) and Flaminal(R)."

[BrauchGeld]

Juni Präsentation :
http://investors.arktherapeutics.com/pdf/PJCConferenceJune20…

outlook 2007

Pharma
Clinical
• Cerepro™
• EMEA decision on MAA ongoing
• DSMB reviews Q2 and Q4
• Vitor™
• Phase III - complete SPA process - mid year
• Commence Phase III H2
• Trinam®
• Phase III - complete SPA process - mid year
• Commence Phase III H2
•Commercial
• OX-LDL-Ab test out-licensing ongoing
• Further IP negotiations/deals
•Pre-clinical pipeline
• Scavidin® further progress Q2
• NP1 progress Q2
• Targeted integrating vector progress and disease
target identification ongoing

[BrauchGeld]

Am Freitag wurden etwas mehr als 2,4 mio aktien gehandelt davon sind rund 2 mio aktien als Kauf durchgegangen :

http://telegraph.digitallook.com/telegraph/security.cgi?csi=…

Ark Therapeutics Group plc
Grant of Key European Stroke Patent


European patent granted for use of agents that affect the angiotensin-renin
system for the prevention and treatment of stroke


July 06 2007, London, UK: Ark Therapeutics Group plc ("Ark" or the "Company") today announces that the European Patent Office (EPO) has granted the Company a patent covering the use of agents that affect the angiotensin-renin system for the prevention and treatment of stroke. The grant triggers a milestone payment from Ark's existing licensee, Boehringer Ingelheim, and may open the way to further commercial agreements with other companies in the future.

The patent (EP 1 498 124 B1) is confirmed as covering 23 molecules belonging to the therapeutic classes of angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor (ATII) blockers, many of which are in late stage development or are already being promoted for stroke. The geographic scope of the patent comprises the 18 European countries that belonged to the European Patent Convention in 1998. The European patent will give protection in the applicable European countries until 2018 and is effective from 1998. Separate patent applications are under prosecution in a number of other international territories including the USA.

In April 2005, Ark signed a licence agreement with Boehringer Ingelheim granting rights to Ark's intellectual property for the use of its products affecting the renin-angiotensin system. The deal comprised upfront and milestone payments and undisclosed royalties on sales of Boehringer Ingelheim's products for the indication of stroke in all territories in which Ark has secured patent protection. Further financial details of the agreement have not been disclosed.

Dr Nigel Parker, CEO of Ark, commented: "We are very pleased to receive the formal grant of this patent. We have always been excited by the novelty and significance of the mitochondrial science supporting the patent, which has now led to grants in three different indications. We are reviewing the final wording of the patent with a view to evaluating the commercial licensing potential beyond our existing deal."

[BrauchGeld]

Hab heute nochmal 3000st.(1,75€) zugelegt ,Ark ist aktuell einfach sehr günstig bewertet .


Ark Therapeutics plans to commercialise brain tumour drug as soon as possible

LONDON (Thomson Financial) - Ark Therapeutics Group PLC said it plans to make its malignant brain tumour drug candidate Cerepro commercially available as soon as possible after it received positive data from the phase III trial to date.

The company said Cerepro extended survival of patients by 15.5 months in cases where most patients will typically only live for around 8 months.

The specialist healthcare group said the independent data and safety monitoring board (DSMB) required no modifications either to the protocol or conduct of the trial and that the DSMB has advised that it should continue to run as planned.

The company said it expects to report the full results of the trial next year.

---------------------------------------------------------

Ark Therapeutics Group PLC 26 July 2007

Positive Outcome from First Data and Safety Monitoring Board Review of Fully
Recruited Cerepro(R) Phase III Study


London, UK, 26 July 2007 - Ark Therapeutics Group plc (LSE: AKT) ("Ark" or the "Company") today provides an update on the Phase III trial (Study 904) being undertaken on its lead product, Cerepro(R), for the treatment of high grade glioma (malignant brain tumour).

As announced in April, the study is now fully recruited with 250 high grade glioma patients. The independent Data and Safety Monitoring Board ("DSMB") met
on 11 July to review the first data from the fully enrolled study. Ark has


been informed by the DSMB that there are no safety issues with the study. No modifications are required either to the protocol or conduct of the trial and the DSMB has advised that it should continue to run as planned.

Study 904 is a standard care controlled study to assess the efficacy and safety of Cerepro(R) in 250 patients with high grade glioma. Patients are randomised in a 1:1 ratio either to standard care alone or to standard care plus Cerepro(R) treatment and patients are blinded to the point of treatment allocation. The multi-centre study is being conducted in Europe and Israel.

Trials completed to date have shown that Cerepro(R) treatment produces an average extension of 7.5 months of life, giving around 15.5 months survival in a disease where most patients will only live for around 8 months.

Cerepro(R) is manufactured by Ark at its cGMP facility in Finland, which was granted the first ever European commercial gene therapy production licence in late 2005.

Nigel Parker, CEO of Ark, said: "The DSMB's recommendation that the Company continue the study without modification or delay represents a significant step forward in the development of this product and Ark's intention to make it commercially available to glioma patients as soon as possible. We look forward to reporting the full results of the Phase III trial next year."


outlook 2007

Pharma
Clinical
• Cerepro™ Phase III
• EMEA decision on MAA ongoing
• DSMB reviews Q2 and Q4
• Vitor™
• Phase III - complete SPA process - mid year
• Commence Phase III H2
• Trinam®
• Phase III - complete SPA process - mid year
• Commence Phase III H2

[BrauchGeld]

Ark Launches Kerraped(R) - the First Therapeutic Footwear
Available on Prescription


London, UK, 20 August 2007: Ark Therapeutics Group plc ("Ark" or "the Company") today announces the launch of Kerraped(R), the first therapeutic footwear to be made available on prescription, for patients with diabetic foot ulcers and other lower limb wounds. The licensing of this product was announced by the Company on 7 June 2007 and it has now been placed on the UK NHS Drug Tariff.

Kerraped(R) All Purpose Boot (APB) is available on prescription from today to help alleviate the suffering of patients with diabetic foot ulcers. Until now, patients in the community have often not had access to suitable medical footwear as it has only been provided via secondary care, for example in diabetic foot, podiatry, and orthotic clinics. Kerraped(R) will be sold by Ark's existing wound care sales force alongside Kerraboot(R) and Flaminal(R), where it is complementary to both products and full promotion will commence on 1 September.

Kerraped(R) APB has been specially designed to be worn by patients with diabetic foot ulcers. It is easy to fasten and provides the appropriate level of off-loading and foot support without interfering with the patient's normal walking gait. In tests, Kerraped(R) has demonstrated a 25% reduction in pressure on the foot surface while walking. A reduction in foot pressure, especially in at-risk areas of the foot, is essential to allow ulcers to heal and prevent recurrence. Kerraped(R) is available in 4 sizes: small, medium, large and extra-large.

Whilst no market data currently exists for this new class of product, the Company estimates the total potential market opportunity in the UK to be between 200,000 and 250,000 units per annum.

Ian Shurville, Head of Wound Care at Ark, commented: "We are very pleased to add Kerraped(R) to our expanding wound care portfolio. We believe that suitable footwear is a key component of wound management for many patients with diabetic foot ulcers and we are confident that Kerraped(R) will make a significant difference to community-based patients previously without access to specialised footwear."

[BrauchGeld]

Es sieht bisher stark danach aus das Cerepro erfolgreich die Phase III tests abschliessen wird.
Für jedes der 3 Produkte in Phase III (Cerepro,Trinam und Vitor) wird ein umsatzpotential von mindestens 400 mio$ angegeben .
In den letzten wochen wurde Ark durch die schlechte markt performance grundlos mit in die tiefe gerissen ,für neueinsteiger bzw. um aufzustocken ist jetzt der beste zeitpunkt gekommen.


Marktkap: 276 mio€
Cash: 55,5 mio€

Broad portfolio – 3 products on market, 3 in Phase III development, commercialised IP,

First DSMB review of fully recruited Cerepro® (Glioma) Phase III trial concludes no safety issues continue as planned


Interims Presentation August 2007
http://investors.arktherapeutics.com/pdf/Interims_presentati…

2007 Second half Outlook

Clinical
• Cerepro®
GMP facilities USA performance standards
DSMB review EOY

• Vitor™
Phase III - SPA outcome
Commence Phase III late H2

• Trinam®
Phase III - SPA outcome
Commence Phase III late H2

Commercial
• OX-LDL-Ab test out-licensing
• Commence IP exploitation

Pre-clinical pipeline
• Finalise develoment programmes for Scavidin®
and new genes
• NP1 progress
• Targeted integrating vector - progress and disease
target identification ongoing

Devices
• Kerraped ® - UK launch
• Kerraboot ® - International marketing and
reimbursement approvals and sales
expected

• Flaminal ® - ongoing sales
Portfolio
• In-licensing of further products

[BrauchGeld]