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.

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.

Thanks - I pretty much only invest in Bios, mostly because I have an academic interest in them (PhD in analytical biochemistry) and partly because I think they are worthy from a moral point of view. Its more fun for me though rather than any serious financial commitment.

Nice rise today, shame there seems to be little discussion on this one anywhere. I also use two other bbs and seem to make most of the posts on them. Perhaps early approval may start some interest, although I don't really want the threads to be full of traders

Pleasure - I dabble a little. Apart from AKT I have modest holdings in AKR, CEN and OXB. Any strong views on any of these?

I hold OXB and CEN.

CENs results today are OK but largely predicted, I will probably get out of these soon. OXB has more interesting products which are more difficult to value. I'd like to see some hard end points such as survival times before making any other decisions. The management there also talk up potential deals but have yet to sign one so remain unproven. I also hold alizyme - they are similar to OXB with the deals lacking.

My track record of picking stocks is somewhat mixed. I did very well (+100%) with Chiroscience and Alizyme but lost badly on Xenova/Scotia/Regen/Phytopharm. Nature of the beast I suppose.

Interesting thoughts, thanks. I'm 100% up on OXB but continue to hold as I think there's a way to go with these yet. I'd forgotten that I hold RGN & AZM as well, both at a loss although AZM seems to be waking up a little. I've obviously got more exposure to the sector than I thought although all the holdings are extremely modest.

Excellent news today Dr Biotech and a good market reaction for a change. Things are looking good for AKT!

More on the patent...there is a lot more to this company than cerepro and trinam

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.

For the six months ended 30 June 2006, Ark's turnover fell 88 percent to 148,000 pounds on lower sales.


For the full year analysts forecast turnover of 1.1 million pounds, down 53 percent from the same period the previous year, according to Reuters Estimates. They forecast turnover of 6.2 million for 2007.

Very, very encouraging Dr Biotech.

Ark Therapeutics said that it has been given clearance ahead of time by the US Recombinant DNA Advisory Committee for its planned pivotal Phase III clinical study of Trinam in the US. Trinam is Ark's novel gene-based therapy to prevent haemodialysis access graft blockage.

After the initial review, the committee decided that the application does not require further review and public discussion, said specialist healthcare firm Ark. The company will now undergo Special Protocol Assessment for the Phase III study, which will involve at least 200 patients, with the FDA. The trial is expected to start in the second half of 2007 once this is complete.

another good rns today, but almost no reaction or trade

I'd hardly call a rise of 3.5% no reaction but based on the information released I would have hoped for a bigger jump.

most of it + the volume after i had posted

Of course it was, silly old me. It must have been a busy last half hour.