Bought some of these this morning as Instiutional interest as really boiled up over them. They have just announced a very positive deal and from what I can see theres quite a lot of news flow in the pipeline to keep this one going throughout the rest of the year. Its highly speculative but give me a Bio company that isnt.

Heres just a little historical detail about the company from the last results prelims 31/12/2004.

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.'

ARKs History

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.

You can find full details of the last results here, http://www.uk-wire.com/cgi-bin/articles/200503100700205623J.html

Worth a punt I feel but as I have previously stated its high risk.

DYOR.

cheers GF.

And more good news:

Ark Therapeutics gets 2.19 mln eur grant for new Finnish manufacturing facility
AFX


LONDON (AFX) - Ark Therapeutics Group PLC said it has received a 2.19 mln eur grant from the Employment and Economic Development Centre of Finland for its new GMP manufacturing facility.

The facility is currently being prepared for commercial-scale manufacture of Cerepro, a gene-based medicine for the treatment of brain cancer. The new facility will significantly increase Ark's manufacturing capacity and scope in the gene-based medicines.

Work on the facility has already commenced and Ark Therapeutics expects it to be operational for validation to commence towards the end of 2007.

newsdesk@afxnews.com

Cheers, Madison

Splendid news Madison. The sp needs a bit of a push. Let's hope this does it!

I assume the rise which started on Friday 11/11 results from Nomura reiterating "strong buy" but changing price target from 249 to 349. Seems a bit fantastical to me, but I'm not complaining about this rise!

Cheers, Madison

349? Slowly but surely!

BrainsTrust Market Report: Fair wind pushes Ark up the league

Published: 15:10 Wednesday 16 November 2005
By: Cliff Feltham, Companies Correspondent

Strong demand for healthcare group Ark Therapeutics pushed the shares up nearly 12% last week and into 20th place in the Citywire BrainsTrust SmallCap index.

The group (AKT) is engaged in research into a number of gene-based medicines and a surfeit of encouraging news during October fuelled the rise, which has left the shares 44% up on the year. Broker Nomura says the company is on track to deliver three innovative drugs and has lifted its valuation of the shares to 358p against 114p today.

Cheers, Madison

Thanks Madison - still very encouraging.

Is anyone else still in these (GF?)....

SP doing very well lately.

Surely this last batch of large trades showing as sells cannot all be really sells or sp would have plummetted? I have been watching this stock for a long time, and it seems to me that the classification of buys and sells is particularly unlikely. Anyone else have this suspicion, or is it just my imagination?

Cheers, Madison

Not sure Madison. Down again today though but still feels strong.....

Ark Therapeutics Group PLC
12 January 2006




Ark Receives US Patent for Kerraboot(R)



12 January 2006, London UK: Ark Therapeutics Group plc today announces the grant
of its patent in the US, Patent Number 6982358, for Kerraboot(R), a novel
woundcare device for the management of leg and foot ulcers. Kerraboot(R) has
already been listed for marketing by the Food and Drug Administration in the US.



Kerraboot(R) is currently marketed by Ark in the UK with increasing clinical
success reported amongst nursing and hospital communities. Late last year Ark
launched a new and more versatile extra-absorbent version of the device to
extend both the range of ulcers that can be treated and the length of treatment
for more exudative wounds. Launched in response to market demand, the new
version has had a very favourable reception from nurses and other healthcare
providers. The Company also intends to release an opaque version in early 2006
for those patients who do not want their wounds to be visible. The Company has
signed distribution agreements for Israel, Ireland and South Korea, and further
such agreements and the commencement of international sales are expected during
2006.



Lower leg and foot ulceration affects around 1% of the adult population in the
developed world1 and is particularly prevalent amongst the diabetic population,
in which the ulcers can develop rapidly, are particularly difficult to heal and
can sometimes lead to amputation.



Kerraboot(R) provides a new approach to the management of these ulcers, in the
form of a novel, non-pressurised, boot-like dressing device, which is simple,
quick and less painful 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
current standard 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.



Nigel Parker, Chief Executive of Ark, commented: 'The US patent has been a while
coming and its grant will now enable us to progress our commercialisation
strategy for Kerraboot(R) in the US market. We are increasingly encouraged by
the number of independent case reports being published demonstrating the
effectiveness of Kerraboot(R) and by the response to the new version. We are
also now seeing Kerraboot(R) being taken up by increasing numbers of primary
care trust formularies in the UK. We believe that there is a significant
opportunity for Kerraboot(R) in the US market and we look forward to updating
shareholders regarding our UK and international progress in the coming months.'

Excellent news Madison, thanks.

Excellent news - and the sp down. Why???????????????/

15 February 2006, London UK: Ark Therapeutics Group plc today announces that it
has signed an exclusive licensing agreement granting Sino Tau International
Company Limited (Sino Tau), a Chinese healthcare company, the sales and
marketing rights to Kerraboot(R) for the Chinese market. Kerraboot(R) is Ark's
novel wound care device for the management of leg and foot ulcers. Sino Tau,
based in Beijing, is an established distributor of both pharmaceuticals and
medical devices in China and markets products through its own sales and
sub-distributor network.

Under the terms of the licence, Sino Tau will be responsible for all the
processes necessary to market Kerraboot(R), including obtaining the necessary
Government and regional approvals. Ark will supply the product to Sino Tau at
an agreed transfer price. Other financial terms of the transaction were not
disclosed.

China has a population of 1.3 billion and lower leg and foot ulceration affects
around 2% of the adult population. At present, approximately 40% of the Chinese
population is able to afford western healthcare products and these people are
located in the main urban areas. The market potential for Kerraboot(R) in
China is very large and it will initially be marketed for the growing problem of
diabetic ulcers and those venous ulcer patients who are intolerant of current
treatments, giving an estimated initial target group of 160,000 patients(1). The
prevalence of diabetes in China is approximately three times higher than 10
years ago and China now ranks second, behind India, as the country with the
highest prevalence, with an estimated 24 million diabetic population1.
Diabetics are 25 times more likely to lose a leg by amputation than non
diabetics and it is estimated that 50,000 diabetes-related lower extremity
amputations are performed each year in China, of which 85% are preceded by a
foot ulcer(2).

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 wound 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% were observed over the four-week study period, with both healthcare
professionals and patients expressing a strong preference for Kerraboot(R) over
current standard 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 saving up to 50% of nurse time and with patients
often becoming nurse independent. Late last year Ark launched a new and more
versatile extra-absorbent version of the device to extend both the range of
ulcers that can be treated and the length of treatment for more exudative
wounds. Launched in response to market demand, the new version has had a very
favourable reception from nurses and other healthcare professionals. Ark will
be supplying the extra absorbent version to its international licensees.

Nigel Parker, CEO of Ark, commented: 'The flow of independent case histories
illustrating the effectiveness of Kerraboot(R) in managing leg ulcers has been
of increasing interest to potential partners. This licensing deal with Sino Tau
opens up a very substantial market in which Kerraboot(R) can make a significant
impact on those suffering from these serious conditions. We continue to discuss
licensing arrangements with other international partners to bring the benefits
of Kerraboot(R) to the greatest possible number of patients.'

Bought in first thing on this news and promptly sold out again as I am worried about the reaction.

One problem I have with the announcement is that they do not mention financials, which is unusual for bios as they like chucking numbers around.

I will wait to see if there is anything further brought to light in the press.

Interesting news re the placing today. Seems there's a lot of interest.

So what's new with AKT? Nice little rises the previous two sessions and a good rise so far today. News around the corner?

I bought shares in AKT on Tuesday 29th of this month.

I thought it strange that it never showed. Not the norm is it.

So this is why we've had the nice rises these past few days:

Ark Therapeutics said it observed improvements in metabolic risk factors in initial results from the open label one year extension phase of its exploratory phase II study of EG005 for the treatment of lipodystrophy -- the accumlation of central body fat -- in HIV positive patients. The company said the patient group completing the extension phase showed 'little or no deterioration from baseline in mean scores for the main disease markers of central and peripheral fat and total body fat measurements nor in the waist, trunk, hip and thigh measurements'.

However, individual patients showed considerable variation from baseline by the end of the treatment period, although mean scores for the main body shape measurements indicated that the group overall had not deteriorated significantly whilst on treatment. In addition the overall group showed no deterioration in mean lean body mass score during the study.

John Martin, CSO said: 'This initial study seems to support the hypothesis that EG005 has a beneficial metabolic effect and specifically on the cardiovascular and diabetic consequences of the disease. It would suggest further exploratory work is needed to investigate these effects before determining how to take the product into full development.'

Ark Therapeutics Group plc today announces that its devices subsidiary, Patient Plus Limited, has signed a pilot distribution and marketing agreement with the US medical products distributor, Health Care Logistics Inc. ('HCL') for Kerraboot(R), Ark's novel wound care device for the management of leg and foot ulcers.

This exclusive agreement, initially for one year, will establish first sales of Kerraboot(R) in the US and will allow Ark to obtain data supporting the health economic benefits of Kerraboot(R) for this market. In Europe, it has been demonstrated that the use of Kerraboot(R) in patients with diabetic leg and foot ulcers can result in a reduction in total healthcare costs of up to 48%(1). Under this pilot agreement, HCL will access its established healthcare customers in the Eastern US Seaboard States(2), including hospitals, nursing homes, long term care centres and home health agencies. Ark will supply Kerraboot(R) at an agreed 'cost-plus' transfer price to HCL and will also provide corporate product support and assistance in establishing usage with certain key US opinion leaders who have expressed an interest in the product. Sales through this arrangement are expected to make a positive financial contribution to Ark during the initial period. Kerraboot(R) is already listed by the FDA for marketing and the US patent for the product was granted to Ark earlier this year.

Lower leg and foot ulceration affects around 1% of the adult population in the
developed world(3) and is particularly prevalent amongst the diabetic population, where the ulcers can develop rapidly and are particularly difficult to heal. The US is estimated to have a potential target market of 270,000 leg and foot ulcer patients suitable for Kerraboot(R) at any one time(4).

Paul Higham, Commercial Director at Ark, commented:

'We are very pleased to announce this agreement with HCL. We believe they offer
the right capabilities to facilitate the entry of Kerraboot(R) into the US market and allow us to start building a data package which will demonstrate both the economic advantages of the product to US payers and confirm its clinical benefits to patients. We look forward to working together with them'.

Ark Therapeutics 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 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.

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 AKT. Piper Jaffray has penciled in sales of 40 mln stg for Cerepro by 2009, if it makes it to the market. It 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 AKT 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.

Positive surprises in terms of the required size and number of trials required could be announced, potentially paving the way for talks with licensing partners, the broker wrote.

This seems to be one of the best bios around but little active discussion on any BB. I found this yesterday

Source: Pharmaceutical & Diagnostic Innovation, Volume 3, Number 9, 2005, pp. 13-16(4)

Over the past two decades, virtually no progress has been made in the treatment of glioblastoma multiforme (GBM), the most common and aggressive type of brain cancer. With a 2-year survival rate typically only 8% to 12%, the standard therapeutic regimen of surgery, radiation and adjunct chemotherapy has minimal efficacy. Consequently, much attention is focused on novel therapies in the pipeline. Drug candidates currently in development for high-grade glioma and GBM represent a wide range of experimental approaches, including targeted biologics, gene therapies, molecularly targeted compounds, novel chemotherapies and radiation-sensitizing compounds. An approach with particular promise is the intracranial administration of tumor-targeting biologic agents linked to radioactive molecules or bacterial toxins. Three such agents are in phase III clinical trials - Cotara from Peregrine Pharmaceuticals, TransMID from Xenova and cintredekin besudotox from NeoPharm. A novel gene therapy that has exhibited very promising results in phase II trials is EG009 (Cerepro ) from Ark Therapeutics, which involves thymidine kinase transfection of healthy brain cells rather than tumor cells. Various molecularly targeted drugs are in mid-stage clinical trials - including a transforming growth factorβ 2-targeting antisense compound from Antisense Pharma, a protein kinase C inhibitor from Eli Lilly and an angiogenesis inhibitor from Merck KGaA. Although progress remains slow, it is likely that as these new therapies emerge from the pipeline, incremental gains in survival of patients with GBM can be achieved.


Of these Cotara has yet to report results. Neopharms drug failed in PIII, EliLillys drug failed and so has Transmid. (as a former Xenova holder its of extra interest to me).All failed through a lack of efficacy.

Im not really sure what the implications are for Cerepro. This demonstrates that

1) Effective treatments for Gliomas are very difficult with PIII results often not reflecting the promising PII data, although in my opinion cerepros data was most impressive (and also there are different forms of glioma so comparison isnt straightforward)
2) Should cerepro get approved I think it may be some time until a rival treatment will surface
3) Assuming that approval is given it will be under exceptional circumstances. This means that it can be sold but it will be subject to review when more data becomes available. Hence the results of the PIII/IV trial will still be very important, probably more important than the EMEA decision
4) Im not sure whether other drugs failing is a good or bad thing as far as Cerepro is concerned. I guess it may help approval. Of course though, its not good for the unfortunate patients and their well being is more important.

Good post Dr Biotech, especially your last point. I feel that in pursuit of the s we can sometimes lose sight of what really matters in this world.