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Crucell & Ark Therapeutics

1. flosz 10 maart 2008 08:16

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   N.a.v. post oudje:
   oudje - 9 mrt 08, 21:07
   Toch is er meer.
   
   Ron Banged schrijft op het IV-forum, dat Trinam in fase 3 zit met fast track.
   Zoek in Google naar "Trinam" en klik dan eens op:
   Regulatory News Announcement: ARK Tharapeutics Grp. - Trinam (R) RAC.
   Volgens dat artikel zou fase 3 starten omstreeks midden 2007 en circa 18 maanden duren.
   Het zou te loven zijn, als op 12 maart a.s. hier wat meer duidelijkheid over gegeven zou worden.
   www.iex.nl/forum/topic.asp?forum=228&...
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   (@ diederique: Het bloed kruipt waar het niet gaan kan….)
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   Published: 08:00 18.01.2006 GMT+1 /HUGIN /Source: Crucell N.V. /AEX: CRXL /ISIN: NL0000358562
   
   Crucell and Ark Therapeutics Extend PER.C6® Agreement with Commercial License
   
   Leiden, The Netherlands, January 18, 2006 - Dutch biotechnology company Crucell N.V. (Euronext, NASDAQ: CRXL) announced today that UK-based Ark Therapeutics Group plc (LSE: AKT) has decided to renew its PER.C6® technology licensing agreement. Under the renewed agreement, the parties have negotiated research and also commercial terms for Ark's development and manufacture of gene-based medicine using Crucell's PER.C6® technology.
   
   Crucell en Ark Therapeutics breiden PER.C6® overeenkomst uit met commerciële licentie
   Leiden, 18 januari 2006 - Het Nederlandse biotechnologiebedrijf Crucell N.V. (Euronext, NASDAQ: CRXL) heeft vandaag bekendgemaakt dat het in het VK gevestigde Ark Therapeutics Group plc (LSE: AKT) heeft besloten om zijn PER.C6® licentieovereenkomst te verlengen. Op grond van de verlengde overeenkomst zijn de partijen onderzoeks- en ook commerciële voorwaarden overeengekomen voor Ark's ontwikkeling en productie van op genen gebaseerde medicijnen met behulp van Crucell's PER.C6® technologie.
   
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   Uit posting van maxen:
   
   Crucell Signs Licensing Deal With Eurogene Ltd. for PER.C6 Packaging Cell Technology
   Leiden, The Netherlands, December 18, 2000 - Crucell N.V. (EAX Amsterdam: CRXL; Nasdaq: CRXL), a Netherlands based biotechnology company, today announced that it has signed a licensing agreement with London based Eurogene Limited for access to its PER.C6 technology.Under the terms of the agreement, Eurogene will license Crucell's PER.C6 adenoviral packaging cell line for research purposes, with an option to convert to a commercial license within five years. In return, Crucell will receive an up-front payment with further annual payments along with royalties on net sales of adenoviral gene therapy products arising from the agreement. "This is our 14th PER.C6 license agreement, confirming the 'industry standard' position PER.C6 has attained in the field of adenovirus based gene therapy products and vaccines." commented Dinko Valerio, Crucell's President and CEO. "We are excited that not only major pharmaceutical companies, but also an increasing number of top tier biotechnology firms, recognise the importance of our PER.C6 technology. PER.C6's strength is also reflected in the fact that earlier this year, clinical trials were initiated with PER.C6 derived adenoviral vectors. Adenoviral vectors are rapidly gaining importance in the industry, which is reflected by the 55 Investigational New Drug applications that were filed at the FDA this year. We have also noticed this trend having an impact on Crucell's contract manufacturing activities in our cGMP facilities".
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   Trinam®-Background, pag. 16 t./m.20.
   
   Prevention of blockage of haemodialysis access grafts•Combination of adenoviral VEGF-D gene and proprietary bio-
   degradable local drug delivery device (EG001)
   ..“Collar” fitted around vein/graft junction during normal surgical procedure
   ..“Drug” injected into cavity between “collar” and blood vessel
   Market opportunity -150,000 suitable cases per year (US and Europe)
   Potential £500m per annum peak sales
   
   Trinam®-Current Status
   Orphan Drug Status
   Patent granted in Europe giving protection until 2017
   Phase II trial - Ascending dose safety study with efficacy as secondary endpoint
   Initial low dose results showed
   No biodistribution with EG001 delivery device
   Exceptional efficacy results
   Trinam®-Progress
   H1 Progress
   Enrolment of control (standard care) and high dose group completed
   Post Period
   Preliminary results Phase II ascending dose study announced
   Trinam®-2006 Progress
   Phase II
   •Preliminary results
   •No biodistributionat either high or low dose
   •Monitoring ongoing for patients’ lifetime
   
   •Exceptional efficacy results
   •Controls 3.3 months average patency
   •Low dose improved to 17.8 months average patency
   •High dose 8 months average patencyso far and all remain open www.arktherapeutics.com/uploads/files...
   
2. flosz 10 maart 2008 08:17

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   Under US regulations, patients in gene therapy trials are monitored for life. The data to date from this study indicates that Trinam(R) has an acceptable safety profile and a clinical effectiveness well beyond the Company's expectations. The Company plans an end of Phase II meeting with the FDA towards the end of the year in preparation for the Phase III study. Approval for a study has already been received from the US Recombinant Advisory Committee. We are delighted with Trinam(R)'s progress and the efficacy results to date confirm our original enthusiasm for the product's potential. miranda.hemscott.com/servlet/HsPublic...
   
   Ark Therapeutics Group plc
   Annual report and accounts 2006
   
   Trinam®
   Following encouraging early stage clinical results in late 2005,
   we were delighted to announce the completion of the USbased
   Phase II ascending-dose safety study in kidney dialysis
   patients who have undergone vascular access graft surgery.
   Preliminary results of the full study showed that Trinam® has a
   good safety profile with no adverse events being reported
   beyond those consistent with the operative procedure. Ark’s
   patented local delivery device (EG001), which delivers Trinam®
   gene-based medicine to the desired site, has proved highly
   effective in limiting systemic distribution around the body. No
   quantifiable levels were detected systemically in any patients
   treated with the drug. Additionally the efficacy data, which
   was a secondary end point in this trial, were extremely
   encouraging. Whereas controls were showing an average
   blocking time of four months, the treatment groups were
   remaining open for between two and four times longer. This is
   highly clinically significant for these patients, meaning that
   instead of having up to three operations per year, only one
   would be necessary.
   
   Finally in December 2006 the Company held the key ‘End of
   Phase II’ meeting with the FDA to discuss the Phase II results
   and the possibility of conducting a Phase III study. We were
   very pleased to report in early January 2007 that the FDA had
   determined that the data were good enough to allow us to
   proceed to Phase III. They also confirmed that this study alone
   would be acceptable as the basis for approval, that our
   manufacturing was acceptable and that they were willing to
   offer Special Protocol Assessment to finalise Trinam®'s clinical
   development.
   The 2006 progress has confirmed our view that Trinam® is a
   very important product for both patients and the Company.
   
   We look forward in 2007 to building on the achievements of the
   past year and reporting both on the outcome of the Cerepro™
   MAA filing and the completion of recruitment to the Phase III/IV
   study. Furthermore, we expect to announce completion of the
   Special Protocol Assessment process with the FDA for Trinam®
   and commencement of recruitment in the Phase III studies for
   both Vitor™ and Trinam®, as well as progress in our other
   commercial and research activities.
   
   The Remuneration Committee has, therefore, concluded that the
   use of TSR in assessing performance for vesting of share-based
   incentives should be replaced by a number of specific, externally
   verifiable corporate milestones, the achievement of which over a
   three year period would determine whether and to what extent
   options and LTIPs vest. Accordingly, for option awards made
   under the Executive Plans, the Consultants' Plan and the LTIP, the
   following milestones have been identified for the 2007 grant of
   options.
   1 January 2007 – 31 December 2009
   1. Approval of Cerepro™ in Europe or USA 30%
   2. Vitor™ – execute processes to complete Phase III study 15%
   3. Trinam® - execute processes to complete enrolment into
   Phase III study 20%
   4. Build profitable, stand-alone woundcare/devices business 10%
   5. Further exploitation of ACE/ATII receptor/stroke patent 15%
   6. Expand clinical portfolio with at least one further candidate 10%
   
   TRINAM®
   2005
   • Positive first stage (low dose) Phase II results presented at
   American College of Surgeons Congress
   2006
   • Phase II trial completed, positive preliminary Phase II results
   announced
   • Positive “end of Phase II” meeting held with FDA
   Looking Ahead - 2007
   • Complete Special Protocol Assessment process for Phase III
   • Commencement of Phase III study
   investors.arktherapeutics.com/pdf/Ann...
   
   Uit 2007(mrt.).
   FIRST TRINAM® EXPERT WORKSHOP
   
   Pre-Clinical and Clinical Development
   Collar
   
   • The use of the collagen collar and its associated application in the Operating Room (OR) was discussed.
   
   • Comments from investigators involved in the phase II study highlighted some issues with removing the collar from the mandrel and issues surrounding the placement of the collar around the anastomosis. The experts present with experience of the recently developed improved collar commented that it performed much better than the first version when used in recent pig studies. The issue of end-to-side anastomoses had been solved by the new prototype design, which included a hole in the top of the collar to accommodate insertion of the graft.
   
   • It was pointed out that Ark needs to be careful that the equipment used to warm the collagen glue for both the phase III study and subsequent commercialisation must be easy to use and function properly. The surgeons involved in the phase II study suggested that there was a training element required to being able to use Trinam, but this was not very significant and should be easily accommodated into an initial training programme at the time of commercialisation.
   
   • It was noted that it is obvious when the collar is not fitted correctly, and that to insert the needle appropriately is not difficult. However, the usual concern about more widespread use post-approval was raised and Ark should be aware that whatever they could do to minimise the risk of misplaced application or stick injuries should be considered as phase III development progresses. “There is a learning curve to this but it’s a short learning curve.”
   
   • Discussion was held as to whether the collagen glue is the most appropriate sealant to use and it was generally agreed that this is appropriate as it fits with the overall biodegradable collagen theme.
   
   • The ability to do end-to-side anastomosis was felt to be a significant positive step forward allowing easier surgery and allowing many more patients to be included as part of the study recruitment for phase III.
   
   • A summary of the phase II safety study results was presented and the overall reaction of the group was that the study had demonstrated Trinam to be safe in the patient population studied. The collagen collar had effectively limited biodistribution.
   
   • It was harder to draw firm conclusions from the patency data. Although these were positive it was in a small number of patients and so it is appropriate to move forward into a larger phase III study, where patency can be definitively determined.
   
   
3. flosz 10 maart 2008 08:18

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   • Discussion centred around the usefulness of VEGF in the setting and whether a relatively short-lived effect was able to have an impact on long-term patency. It was felt that the hypothesis of limiting vascular injury and improving the early healing response to improve long-term outcome was appropriate and the Phase III study would be designed with this hypothesis in mind.
   
   The group was able to clarify the sometimes confusing definitions of primary patency, primary assisted patency and secondary and overall patency. Ark described that the primary endpoint of the phase III study would be to look at overall graft survival. Subsequent discussion raised the question of whether primary patency would not be a more appropriate endpoint and the overall conclusion was that the secondary overall patency was the least subjective measure and the one most clearly linked with patient benefit. For these reasons this is the primary endpoint suggested by Ark and agreed with the FDA as the appropriate endpoint for the phase III study.
   
   • Further discussion on the design of the phase III study centred around the fact that the study would be open label in that the surgeon would not apply a graft or a dummy solution in the control arm. The control arm was suggested as such because it is unknown in man if the collar alone could exert a treatment effect (although no collar-alone treatment effect has been evident in the animal studies conducted) and would therefore not be a true placebo. From this, the issue of potential investigator bias was raised and discussed. Ark pointed out that the patients would be randomised in the OR to eliminate investigator bias in patient selection and that through Special Protocol Assessment Ark and the FDA will agree a protocol that would minimise potential investigator bias going forward.
   Vascular Access Trends
   • The current trends in vascular access were presented along with the KDOQI/CMS targets for prevalence of fistulae.
   • In summary, the group felt that the KDOQI/CMS target of 66% prevalence of fistulae by 2009 was unlikely to be achieved and furthermore Ark’s projection of 55% may also not be achieved by that time. The main reasons for this are that it is felt fistulae may already be being used inappropriately in some patients who would derive greater benefit from a graft and early movement away from catheter.
   “I don’t think fistula prevalence will get near the levels seen in other cultures or countries Surgeons have too quiet a voice regarding KDOQI guidelines…. For instance, it may be much more appropriate to put an elderly patient on a graft and get them off the catheter.”
   In addition, the US population is different from Asia or Europe in that there is a higher prevalence of obese and diabetic patients and that in the future there is expected to be a large elderly population in whom fistulae are both more difficult to place and are less likely to mature.
   • There was general agreement that around 30% of fistulae failed to mature and that in quoting patency rates this is often underrepresented in the literature.
   • There was a discussion about average patency rates for fistulae compared with grafts and comments were made that when taking into account the failure to mature rate, the patency rates for fistulae and grafts are similar at 12 months.
   • Catheters are the most expensive access procedure to maintain and suffer from an average rate of infection of 1 per year, each episode of infection costing an average of $56k. The overall prevalence of haemodialysis presented was thought to be reasonable and the projections of annual growth rate of 4% were felt to be appropriate or even a little conservative.
   • It was felt that it is unlikely that the prevalence of graft use will fall below 100,000 patients in the US. The reasons for lower success rates of fistulae in the US compared with Europe were discussed. Important factors were felt to be the population demographics (as already discussed), the higher flow rate used in the US and the competence level of technicians routinely dialysing patients in US centres.
   • There was also a discussion on the appropriateness of the KDOQI guidelines going forward. The US vascular surgeons present felt that they had been underrepresented in discussions to date and had not had sufficient influence on the guidelines produced. It was felt that the vascular surgeons should attempt to assert their views more systematically into the process and some commented they felt that the current drive to majority fistula use could potentially harm patients by placing them in inappropriate patients who would then have difficulty with subsequent access in whom the fistulae failed to mature leaving them open to complications from continued catheter access.
   “I’ve got data on 1,700 patients over the last four or five years and it shows that there is no statistical difference between using a fistula and a graft”
   
   Trinam Target Product Profile
   It was agreed that if Trinam could deliver a result of doubling patency compared with standard grafts then it would be used in a very large proportion of patients receiving grafts. Critical to this area will be the Pharmaco-economic arguments that can be made.
   Use of Trinam will need to deliver overall cost savings to the Health Care System. It is therefore critical that the phase III development programme adequately covers all the relevant pharmaco-economic issues. This includes examining all the associated costs with graft placement including patient visits, screening, radiology costs, surgeons’ professional charges, dialysis and any parallel catheter placement required. A rough estimate of all of these costs was suggested at around $30-40k per graft placement.
   
   • Ark should examine this area very carefully and ensure that all the relevant data is captured as part of the Phase III programme and a subsequent pharmaco-economic evaluation of Trinam in this setting is produced. The majority of patients in this setting will be treated on an outpatient rather than inpatient basis and this also has implications for subsequent reimbursement of the product following approval. The estimate is that Trinam would be used in 90% of cases in an outpatient setting and in 10% as an inpatient procedure.
   4. Customers – how and by whom will Trinam be used
   • The various players associated with the potential use of Trinam were discussed and it was agreed that the visual presented by Ark covered all the key players likely to be involved in the decision to use Trinam. Whilst it was felt that nephrologists would have a strong influence on whether Trinam was used and could exert influence by deciding to refer patients to particular surgeons, it was felt unlikely that nephrologists would ultimately determine the type of vascular access to be used. The vascular access surgery itself would be conducted by a number of different types of surgeons. The estimate given was that transplant surgeons would do 30% of the procedures, 30% would be done by vascular surgeons and 40% by general surgeons. It would therefore be important to be able to access all of these surgical customer groups when commercialising Trinam.
   
4. flosz 10 maart 2008 08:21

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   • There was a brief discussion held on what type of representative would be most appropriate to see these surgical customers and it was felt that in most cases the representative would need to have experience of selling surgically related products, be able to gain access to the OR and be seen as a competent and credible information partner in the early adoption of Trinam in the surgical setting.
   
   • It was also clear that nephrologists would remain an important group and influence of this group could lead to more rapid and widespread adoption of Trinam. The communication with this customer group would be more of a traditional pharmaceutical ‘sell’. It was felt important in the early commercialisation of Trinam to organise training for surgeons and this could be conducted via regional training seminars as well as local training in individual ORs.
   investors.arktherapeutics.com/pdf/Sum...
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   Ark Therapeutics Grp - Trinam(R) RAC Application
   RNS Number:9219V
   Ark Therapeutics Group PLC
   02 May 2007
   
   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.'
   
   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.
   investors.arktherapeutics.com/servlet...
   
   
5. flosz 10 maart 2008 08:21

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   Ark Therapeutics Grp - Trinam Update
   RNS Number:9884W
   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.'
   investors.arktherapeutics.com/servlet...
   Trinam(R)
   Following the requested 'End of Phase II' meeting with the FDA in late 2006, we
   announced early in the period that the FDA had offered Special Protocol Assessment ('SPA') to allow the product to enter Phase III development. The documents allowing the SPA to commence were submitted to the FDA mid-period and the process is now ongoing. The final Phase III trial architecture and data requirement necessary for a marketing approval in the USA will be defined during the SPA. A potential major obstacle in commencing Phase III development was overcome in the period when the US Recombinant Advisory Committee ('RAC') approved the study without the need for a public hearing. The latter again reflects the recent more positive attitude to adenoviral gene-based medicines by the regulators.
   
   Patent portfolio update
   Ark has 53 granted patents and 140 pending applications and continues to be successful in overcoming the various objections and oppositions in the prosecution processes. In the period, the Company has been granted six patents in various international territories covering Trinam(R), Scavidin(R), targeted gene vector technology and other discoveries. During the period, we also successfully prosecuted the European stroke patent. Post period, we have filed applications covering manufacturing processes which if granted would give our gene-based products protection out to 2027.
   
   Research and development expenditure in the first six months of 2007 was £7.8m (six months ended 30 June 2006: £6.2m), reflecting the excellent progress with the Cerepro(R) Phase III study, where recruitment completed during the period, together with preparatory work for the Trinam(R) and VitorTM Phase III studies and the continuing scale-up of our cGMP manufacturing facility in Finland.
   ****************************
   
   H1 2008
   * Trinam(R) - commence enrolment into Phase III trial and
   file Fast Track application
   
   H2 2008
   * Trinam(R) - secure rolling NDA
   
6. flosz 10 maart 2008 08:22

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   Ark Therapeutics Grp - Acquisition
   RNS Number:2662L
   Ark Therapeutics Group PLC
   08 January 2008
   
   Acquisition of Lymphatix brings VEGF gene rights and technology to catalyse
   Ark's gene-based medicine programmes
   
   London, UK, 8 January 2008 - Ark Therapeutics Group plc ('Ark' or 'the Company')
   announces that it has agreed to acquire Helsinki-based company Lymphatix Oy in
   an all share transaction equivalent to a purchase price of Euros 2.25 million.
   The acquisition gives Ark royalty-free exploitation rights to the vascular
   endothelial growth factor genes known as VEGF-D and VEGF-C for developing
   gene-based medicines in the angiogenesis and lymphangiogenesis areas. Ark
   already has VEGF-based programmes in pre-clinical development in these areas,
   notably refractory angina, wound healing, prevention of restenosis and foetal
   growth restriction. Results to date have shown that VEGF plays a key role in
   these diseases.
   
   Ark will incorporate the VEGF portfolio secured with this acquisition alongside
   other genes including its own VEGF mutants, to optimise therapies prior to
   commencing clinical testing. The gene medicines will be developed and tested by
   Ark in the already-established adenoviral vector platforms successfully utilised
   by Trinam(R), which contains the VEGF-D long form and is now in Phase III
   clinical studies, and by Cerepro(R), also in Phase III, in disease models at its
   facilities in Kuopio, Finland.
   
   Lymphatix was founded in 2003 by the Ludwig Institute for Cancer Research,
   Licentia Ltd/Helsinki University and a number of Finnish and Australian
   academics, including Associate Professor Marc Achen, Professor Kari Alitalo, Dr
   Marika Karkkainen, Associate Professor Steven Stacker and Professor Seppo
   Yla-Herttuala, who are together the selling shareholders.
   
   The consideration is in the form of 1,733,657 new ordinary shares of 1 pence
   each in the capital of Ark (the 'Consideration Shares'). Application is being
   made to the UK Listing Authority for admission of the Consideration Shares to
   the Official List and to trading on the London Stock Exchange. It is expected
   that admission will become effective and dealings in such shares will commence
   on or after 11 January 2008.
   
   Following admission of the Consideration Shares, the total number of ordinary
   shares in the capital of the Company with voting rights will be 203,672,626.
   
   Dr Nigel Parker, Chief Executive Officer of Ark, commented: 'This is a highly
   targeted acquisition of specific technology which is well known to us. As well
   as securing our position in this key field, the rights to exploit these genes
   will give us the ability to optimise the constructs we take forward for the next
   generation of gene-based medicines. In the case of our refractory angina
   programme, it could well be a catalyst to move us into the first clinical study
   faster than we had previously anticipated.'
   investors.arktherapeutics.com/servlet...
   
7. flosz 10 maart 2008 08:22

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   Circadian Technologies Limited
   Vegenics was formed in collaboration with the New York based Ludwig Institute for Cancer Research
   (LICR) and the commercial arm of the University of Helsinki, Licentia Limited (Licentia) in April 2006.
   Circadian has to the date of this report invested a total of $21.5 million into Vegenics for a 67% holding.
   The remaining 33% of Vegenics’ shares are owned by LICR and Licentia.
   
   Vegenics also gained
   ownership of third party licensing agreements previously entered into by LICR and Licentia with Ark
   Therapeutics Group plc (LSE: AKT).
   
   Highlights for the half-year ended 31 December 2007 include:
   
   • On 6 November 2007 in an announcement to the London Stock Exchange, Ark Therapeutics
   stated that it expects to commence enrolment of patients in a Phase 3 study of Trinam® (the
   active component, VEGF-D gene, has been licenced from Vegenics) in the first half of 2008.
   Trinam® is a novel product consisting of a local delivery device and VEGF-D gene being
   developed to prevent the blocking of veins and arteries that frequently occurs after vascular
   surgery. The initial target market is haemodialysis graft access surgery, a procedure in which
   patients whose kidneys have failed have a plastic tube grafted between blood vessels generally in
   their forearm so that their blood can be regularly filtered using a dialysis machine.
   Trinam® has completed a Phase II trial, being the first part of the Phase II/III study. Up to
   60 per cent of haemodialysis access grafts block within one year of being inserted due to de novo
   stenosis, so that repeat surgery must be performed. Such repeat surgery frequently fails and can
   only be performed a limited number of times. Alternative and more difficult routes to achieve
   filtration are then required. In these circumstances, the life expectancy of patients can be short.
   newsstore.smh.com.au/apps/previewDocu...
   ***************************
   
   Meer via:
   www.arktherapeutics.com/main/products...
   
   crucell.yourbb.nl/viewtopic.php?f=8&t...
   
8. [verwijderd] 10 maart 2008 10:20

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   Dus per saldo fase 2 reeds lang achter de rug.
   Alleen duurt de voorbereidingstijd van fase 3 wel erg lang. Nu dus start in 1e halfjaar 2008. Die fase 3 zou ongeveer anderhalf jaar duren.
   Mijn dank is groot, Flosz!!
9. [verwijderd] 10 maart 2008 11:05

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   quote:

   oudje schreef:

   Dus per saldo fase 2 reeds lang achter de rug.
   Alleen duurt de voorbereidingstijd van fase 3 wel erg lang. Nu dus start in 1e halfjaar 2008. Die fase 3 zou ongeveer anderhalf jaar duren.
   Mijn dank is groot, Flosz!!
   

   Fijn, te horen dat Crucell er dan wellicht, misschien, hopelijk, als alles mee zit, ijs en weder dienende, bij evt. goedkeuring over 4 jaar hier inkomsten van kan zien.
   
   De andere pruducten in de pijplijn gaan dus nog langer duren?
   
   Lekker vooruitzicht.
   
   :-)
   
   Dirk
10. flosz 10 maart 2008 19:40

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    quote:

    oudje schreef:

    Dus per saldo fase 2 reeds lang achter de rug.
    Alleen duurt de voorbereidingstijd van fase 3 wel erg lang. Nu dus start in 1e halfjaar 2008. Die fase 3 zou ongeveer anderhalf jaar duren.
    Mijn dank is groot, Flosz!!
    

    Uit PB van Ark, d.d. 8 jan., 2008:
    Ark will incorporate the VEGF portfolio secured with this acquisition alongside
    other genes including its own VEGF mutants, to optimise therapies prior to
    commencing clinical testing. The gene medicines will be developed and tested by
    Ark in the already-established adenoviral vector platforms successfully utilised
    by Trinam(R), which contains the VEGF-D long form and is now in Phase III
    clinical studies.
    
    investors.arktherapeutics.com/servlet...
    crucell.yourbb.nl/viewtopic.php?f=8&t...
    
11. [verwijderd] 10 maart 2008 20:32

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    Nou Dirk, dat zou nog mee kunnen vallen.
    Einde fase 2 was lang geleden, schreef ik.
    Dat was vlak voor het midden van 2007.
    En van Flosz weten we nu, dat de start van fase 3 vrij vroeg in dit jaar is geweest.
    Voorbereidingstijd dus ruim een half jaar.
    Ergens in de veelheid van publicaties ben ik tegengekomen, dat fase 3 ongeveer anderhalf jaar in beslag zou nemen.
    Dus ergens in de 2e helft van 2009 zou het licht op groen kunnen springen. Fast track zal m.i. ook inhouden, dat de FDA meeloopt tijdens het proces en derhalve, mits geslaagd, een goedkeuring niet lang op zich laat wachten.
    
    En met een beetje vertraging ingecalculeerd, kunnen de eerste revenuen in 2011 binnenkomen. En als je dan weet, dat we hier met een "blockbuster" te maken hebben, kan dat al gauw enkele tientallen miljoen per jaar zijn, uiteraard afhankelijk van het afgesproken percentage van de omzet.
    
    
12. [verwijderd] 11 maart 2008 08:39

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    Ark Therapeutics Group plc
    Preliminary results for the year ended 31 December 2007
    
    London, UK, 11 March 2008 - Ark Therapeutics Group plc today announces its unaudited preliminary results for the year ended 31 December 2007.
    
    HIGHLIGHTS
    
    Trinam(R)
    * Special Protocol Assistance (SPA) opened for Phase III trial
    * US Recombinant DNA Advisory Committee (RAC) gives early clearance for Phase III trial, expected to commence in H1 2008
    
13. flosz 11 maart 2008 08:45

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    quote:

    flosz schreef:

    Uit PB van Ark, d.d. 8 jan., 2008:
    Ark will incorporate the VEGF portfolio secured with this acquisition alongside
    other genes including its own VEGF mutants, to optimise therapies prior to
    commencing clinical testing. The gene medicines will be developed and tested by
    Ark in the already-established adenoviral vector platforms successfully utilised
    by Trinam(R), which contains the VEGF-D long form and is now in Phase III
    clinical studies.
    
    investors.arktherapeutics.com/servlet...
    crucell.yourbb.nl/viewtopic.php?f=8&t...
    
    

    11-03-2008, 3 mnd. vertraging (FMD- mond- en klauwzeer).
    
    Trinam(R)
    
    The end of Phase II meeting with the FDA in 2006 resulted in Ark being offered
    SPA for the Phase III development. In the first half of the year we filed the
    relevant applications to the US recombinant advisory committee ('RAC') and to
    the FDA to open the SPA. We were encouraged that attitudes to gene medicine in
    the US had also advanced when rapid clearance for the Trinam Phase III was given
    by RAC mid year, without the need for an oral hearing. The SPA progressed
    steadily during the rest of the year and we conducted a further pre-clinical
    study, as requested by the FDA, to expand the number of operative procedures for
    which Trinam(R) might be used. Whilst we had hoped to conclude the SPA in 2007,
    the outbreak of foot and mouth disease in the UK stopped animal movements and
    caused us a three month delay, but work was completed at the end of the year and
    the SPA process is expected to conclude shortly.
    investors.arktherapeutics.com/servlet...
    
14. [verwijderd] 11 maart 2008 09:30

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    Trinam(R)
    
    marktwaarde ???
15. flosz 11 maart 2008 10:22

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    quote:

    Herculess schreef:

    Trinam(R)
    
    marktwaarde ???
    

    Probeer het eens te vinden voor ons!
    Tipje: lees vooral pagina 1.
    
    Pound = +/- 1.31 euro.
16. flosz 19 mei 2008 08:20

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    Ark Therapeutics Grp - Interim Management Statement
    RNS Number : 5937U
    Ark Therapeutics Group PLC
    16 May 2008
    
    Ark Therapeutics Group plc
    Interim Management Statement
    
    16 May 2008 Ark Therapeutics Group plc ('Ark' or the 'Company') today publishes its first interim management statement for the period 1 January 2008 to date. The Company intends to report its results for the six months to 30 June 2008 on 27 August
    2008.
    
    The overall performance of the business during the period has been in line with the Board's expectations.
    
    Highlights
    
    * Timing of Phase III Cerepro® preliminary results confirmed for Q3 2008
    * Good progress made towards start of Phase III trials for Trinam® and VitorTM
    * Acquisition of Lymphatix Oy strengthens gene technology research and secures access to VEGF C and VEGF D genes
    * Positive opinion letter received from EMEA for Cerepro® Paediatric Investigation Plan
    * Finnish manufacturing facility completes validation review to USA standards
    * Ark products win inclusion on new NHS Advanced Woundcare Therapies Contract
    * Neuropad® in-licensed and launched in the UK
    
    Clinical Programmes
    In Cerepro®, the major breakthroughs we achieved in 2007 with the key technical sections of the submission - CMC, pre-clinical and environmental - enable us to contemplate the filing of an application for a full licence once the results of
    the Phase III corroborative study are available in Q3 2008. In the meantime, work on the Finnish expanded manufacturing facilities, commercial-scale production process and sales and marketing infrastructure have proceeded.
    
    Discussions with the regulators during the period concerning the Phase III trials for Trinam® and VitorTM have remained positive and we anticipate being cleared to start both trials by mid-year.
    
    Pre-clinical Programmes
    The acquisition of Lymphatix Oy in January has enabled us to accelerate our plans for a number of VEGF D-based pre-clinical programmes for which clone selection and planning for toxicity studies are well-advanced.
    
    Woundcare
    The good growth seen in our woundcare sales in 2007 has been maintained in the opening months of 2008. The inclusion of Ark's products on the new NHS Advanced Woundcare Therapies Contract and the recent launch of Neuropad® give us further
    confidence for the future success of this business.
    
    Intellectual Property Portfolio
    We have made continued progress in taking our key patents through the international prosecution process. Further progress has been made towards the commercialisation of the 'ACE Stroke' patent and the Company continues to receive enquiries concerning
    licensing of other intellectual property in Ark's portfolio.
    
    Cash
    As we reported in our 2007 annual results announcement, the Company had £65.1m in cash and money market investments at 31 December 2007. Cash usage in the business in the opening months of 2008 has been in line with the Board's expectations
    and Ark remains well-funded to build on its leading position in the gene therapy area. There have been no other significant changes in the position of the Company over the period since publication of the report and accounts for the year ended 31 December
    2007.
    
    Nigel Parker, CEO of Ark, commented:
    
    'The progress achieved in our business in 2007 has continued in the opening months of this year. In our three late-stage clinical programmes, Cerepro® Phase III trial results have been confirmed for the third quarter and progress has been
    made towards starting the Phase III trials for Trinam® and VitorTM. We have commenced work to bring a number of our pre-clinical programmes through the late stage pre-clinical work prior to taking three of them into Phase I trials. I am
    delighted that the sales growth in our woundcare business reported in our 2007 annual results has been maintained in the period. With our broad range of products and strong cash position, we are well placed to continue meeting the objectives we have set.'
    
    investors.arktherapeutics.com/servlet...
    
17. flosz 19 mei 2008 18:41

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    Ark Therapeutics Grp - Research Update
    RNS Number : 7178U
    Ark Therapeutics Group PLC
    19 May 2008
    
    Ark makes significant advances with EG013 and EG014 preclinical programmes
    
    * EG013 is a Trinam® variant VEGF based gene medicine
    
    19 May 2008 - Ark Therapeutics Group plc ('Ark' or the 'Company') today provides an update on two of its preclinical programmes, EG013 and EG014. In November 2007, Ark raised £35.4 million net through a Placing and Open Offer to allow
    investment in a number of advanced preclinical programmes within its gene-based medicine portfolio that had promising results and the potential to move rapidly into the clinic.
    
    EG013 is a Trinam® variant VEGF based gene medicine under development for fetal growth restriction, an often terminal condition where insufficient blood supply via the placenta results in serious growth retardation, leading to premature
    death or undesired termination of a baby in an otherwise healthy mother or long term neurological problems in surviving infants. The problem is usually first diagnosed about 20 weeks into pregnancy and at present there is no effective treatment.
    
    Results from the first trial in a preclinical model of blood flow to the placenta have shown that a single treatment with EG013, given directly into the mother's uterine artery, increased blood flow to the placenta by 25%, an improvement that is
    believed adequate to treat the condition. The latest results of the second set of experiments have shown that the significantly increased blood flow after treatment with EG013 is maintained out to 50 days. If confirmed in human studies, a therapy with
    this magnitude and duration of effect could allow the fetus to grow satisfactorily to a stage where caesarean delivery of a healthy baby could be reliably performed. Preliminary biodistribution results using immunohistochemical techniques have indicated
    that there is no transfer of the gene into the fetus.
    
    Fetal growth restriction, in its various forms, affects approximately 60,000 babies in the USA and Europe and is an extremely distressing condition. The work is being undertaken as a collaboration between Ark's scientists at University College, London
    (UCL) and the UCL Department of Obstetrics and Gynaecology. An abstract describing the work was recently presented at an American Society of Gynaecological Investigation where it won a President's Investigator award.
    
    Commenting on the results, Professor Donald Peebles, Professor of Obstetrics and Fetal Medicine at UCL undertaking the work, said: 'The results from this second set of experiments are again very encouraging. The robust science behind the gene-based
    product led us to believe we would see this effect but it is always exciting to have the theory confirmed. In common with many of the new types of advanced biologics treatments that are coming through, it looks as if we may be on the verge of a major
    treatment breakthrough in an extremely distressing medical condition.'
    
    EG014 is Ark's gene derived small molecule anti-cancer programme centred around the neuropilin 1 (NP1) receptor. Previously reported preclinical results from Ark's early leads have shown that blocking of the NP1 receptor has a triple effect, killing
    tumour cells, reducing blood flow to tumours and inhibiting metastatic spread of the cancer. Work this year using advanced crystallography and computational chemical modelling has led to the recent discovery and understanding of the precise NP1 receptor
    pocket structure and molecular binding site characteristics. Additionally Ark has completed development of novel fast screening assays, highly specific to the above mentioned receptor. These developments are significant advances which now direct Ark's
    chemistry to optimise the existing leads.
    
    Commenting on this, Professor John Martin, Chief Scientific Officer at Ark, said: 'The previous preclinical results with NP1 indicated its potential as a broad treatment for cancer. This precise finding had eluded us for a number of months and we are
    delighted to have made this discovery in such a precise and detailed manner. This allows us to continue what we believe is the last stage of our lead optimisation work in a controlled and systematic way to give us compounds with the right potency and
    binding specificity to take into the clinic.'
    
    Nigel Parker, CEO at Ark, added: 'In the second half of last year we received strong support to progress a number of preclinical programmes and we are very pleased to report this steady and solid progress by our research groups in two of the
    projects. It is extremely exciting for us to see this breakthrough science move forward and the progress confirms our view that advanced molecular medicine has the potential to offer breakthrough treatments in areas of serious unmet clinical needs. We
    look forward to updating the market on progress with these and our other preclinical projects in due course.
    investors.arktherapeutics.com/servlet...
    
18. flosz 19 mei 2008 19:47

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    Review of key gene therapy and manufacturing approaches
    Optimising biomanufacturing processes,
    Brussels 18th–19thMarch 2008
    Robert Shaw, Technical Director, Ark Therapeutics Group London-Kuopio
    
    www.bio-events.com/presentations/08/B...
    
19. flosz 23 mei 2008 09:18

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    Allez allez....de kerk gaat in Per.c6.........
    
    you need Percy, Percy Six, a 22nd century box of tricks
    he'll fix you up if you're not at all well
    he's got a billion brothers and he lives in a cell
    He's gonna save the world one fine day...
    Watch out everybody he's on his way!!!!
    © ch
    **********************************************
    
    Ark Therapeutics Grp - Holding(s) in Company
    RNS Number : 0879V
    Ark Therapeutics Group PLC
    22 May 2008
    
    Notification of Major Interests in Shares
    
    1 Identity of the issuer or the underlying issuer of existing
    shares to which voting rights are attached:
    ARK THERAPEUTICS GROUP PLC
    2. Reason for the notification (please tick the appropriate N/A
    box or boxes):
    An acquisition or disposal of voting rights: (x)
    An acquisition or disposal of financial instruments which ( )
    may result in the acquisition of shares already issued to
    which voting rights are attached
    An event changing the breakdown of voting rights: ( )
    Other ( )
    3. Full name of person(s) subject to the notification
    obligation:
    
    Aberforth Partners LLP
    4. Full name of shareholder(s) (if different from 3):
    
    Shareholder Shares
    
    1. Aberforth Smaller Companies Trust plc 10,702,941
    2. Aberforth UK Small Companies Fund 8,264,726
    3. The Church Commissioners for England 1,854,748
    
    1, 2 = registered in the name of Nortrust Nominees Ltd A/c
    Aberfrth
    3 = The Church Commissioners for England (Chase GIS)
    Nominees Ltd
    investors.arktherapeutics.com/servlet...
    ********************************
    
    The Church Commissioners were formed in 1948 by joining together two bodies - Queen Anne's Bounty and the Ecclesiastical Commissioners.
    The Church Commissioners moved to Church House, Westminster in March 2007 to work under one roof with the Archbishops' Council and the Church of England Pensions Board. The Commissioners' role is to manage the Church's historic assets, today invested in stock market shares and property, to produce money to support the Church's ministry. The Church Commissioners meet some 18% of the Church's total running costs.
    The Church Commissioners' main responsibilities are:
    • to obtain the best possible long term return from a diversified investment portfolio in order (1) to meet their pension commitments and (2) to provide the maximum sustainable funding for their other purposes such as support for the work of bishops, cathedrals and parish ministry;
    • in doing so, to pay particular regard to making 'additional provision for the cure of souls in parishes where such assistance is most required';
    • to administer the legal framework for pastoral reorganisation and settle the future of redundant churches.
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20. flosz 2 juni 2008 08:27

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    Ark Therapeutics Grp - Regulatory Approval
    RNS Number : 7004V
    Ark Therapeutics Group PLC
    02 June 2008
    
    Ark Receives Special Protocol Assessment Approval from US FDA
    for Phase III Pivotal Trial of Trinam®
    
    2 June 2008 - Ark Therapeutics Group plc ('Ark' or the 'Company') today
    announces that, following full review by the US Food and Drug Administration
    (FDA), the application for Special Protocol Assessment (SPA) for its
    Trinam® Phase III trial,
    filed in April 2007, has been successful and the FDA has formally given SPA
    approval. In parallel, the updated Investigative New Drug (IND) application for
    the trial has also been separately reviewed and approved by the FDA, subject to
    a requirement for
    the Company to qualify one product release test relating to potency, prior to
    enrolling patients.
    
    Trinam® is Ark's novel gene based medicine to prevent blood vessels
    blocking in kidney dialysis patients who have undergone vascular access graft
    surgery. Ark will now commence work to start the planned Phase III trial and, in
    addition, intends
    to apply to the FDA for Fast Track Designation.
    
    The SPA process allows Ark to work closely with the FDA to ensure the design
    and conduct of the Phase III development programme, including the definitive
    clinical objectives and data analyses, are appropriate to support a marketing
    licence application
    (BLA). During the course of the SPA review, Ark has conducted a preclinical
    study and provided extra biodistribution data in an 'end-to-side' surgical
    procedure for placement of the graft. The results were in line with those seen
    previously, allowing the
    Phase III trial to include this procedure alongside the existing 'end-to-end'
    placement procedure used in Phase II.
    
    Trinam® is an adenovirus-mediated VEGF D gene delivered with a novel
    biodegradeable local delivery device (EG001). The product has already been given
    Orphan Drug Status in the USA and Europe. The US Recombinant Advisory Committee
    (RAC) gave
    approval for a Phase III study in May 2007. US regulatory review for the
    product comes under the responsibility of the Centre for Biologics Evaluation
    and Research (CBER), the specialist biologics division of the FDA.
    
    The Phase III study will be a US multi-centre, randomised, controlled trial,
    in which the efficacy and safety of Trinam® will be investigated in
    patients with end stage renal disease (ESRD) requiring vascular access for
    haemodialysis. Patients
    with ESRD will be randomised to receive either Trinam® 4x1010 viral
    particles in addition to standard care or standard care alone at the time of
    surgical placement of a synthetic PTFE graft for vascular access. Primary
    Unassisted Patency (time to any
    first intervention) will be the primary regulatory end point and overall patency
    and a number of other important pre-defined clinical endpoints will also be
    measured. Safety will be assessed by an independent Data and Safety Monitoring
    Board (DSMB)
    against a pre-specified set of stopping rules defined during the SPA. The DSMB
    will also undertake a 'sample sizing' analysis after 150 patients have been
    recruited to determine the final trial size. This type of adaptive design is
    relatively new and
    assists groundbreaking drugs to ensure robust efficacy data are available to
    satisfy regulatory requirements as approval standards evolve.
    
    Results from a Phase II open-label, non randomised, standard-care controlled
    trial of Trinam®, previously reported in March 2007, indicated that the
    access grafts of patients given the planned dose of Trinam® exhibited
    almost three times the
    Primary Unassisted Patency compared with controls. Overall patency data from the
    Phase II study further showed Trinam® treatment resulted in grafts
    remaining functional for dialysis, on average, over three times longer than in
    untreated controls.
    Trinam® was well tolerated with no quantifiable systemic distribution of
    the product found and no serious side effects were exhibited other than those
    consistent with the nature of the operation and condition.
    
    Nigel Parker, CEO of Ark, commented: 'This is very good news at the end of
    what has been an extremely rigorous and detailed review by the FDA and we are
    delighted to have been successful in achieving SPA for this pioneering gene
    based medicine. The
    FDA has provided constructive assistance to ensure we conduct the right study
    for a medical problem which is identified in the 2010 US Health Peoples
    Directive as of high clinical need. We will now get on with the test work
    alongside finalising
    administration to commence the trial. We look forward to updating the market
    regarding Trinam®'s progress in due course.'
    investors.arktherapeutics.com/servlet...