Crucell Terug naar discussie overzicht

Ark therapeutics met PER.C6 drug in phase II

1. [verwijderd] 4 juni 2006 19:33

   auteur info

   • [verwijderd]

     Lid sinds: 01 jan 0001

     Laatste bezoek: 01 jan 0001

   • Aanbevelingen

     Ontvangen: 0

     Gegeven: 0

   •    Aantal posts: 0

   Ik zie net dat Ark therapeutics met haar klinische programma's in fase II/III is aanbeland.
   
   www.crucell.com/Partners%20-%20Genera...
   
   Volgens mij moet het dit product zijn
   
   www.arktherapeutics.com/main/index.ph...
   
   Trinam® (EG004) – a product to prevent blood vessels blocking after vascular graft surgery, in preparation for Phase II/III development
   
   Trinam® (EG004) – treatment to prevent blocking of blood vessels after surgery
   Trinam® is a novel product consisting of a local delivery device and a gene-based medicine, 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® is currently in a Phase II trial, this being the first part of the Phase II/III study for which it has received approval from the US Recombinant DNA Advisory Committee (RAC).
   
   Clinical condition
   After vascular surgery, an overgrowth of muscle cells can occur in the wall of the otherwise healthy blood vessels. Known as intimal hyperplasia, this is a significant problem as it can cause a complete blockage (de novo stenosis) of the blood vessel which usually results in the need for further surgery to avoid serious complications.
   
   Patients who have kidney failure require their blood to be filtered through a dialysis machine to prevent them from dying. The process is normally carried out at least twice a week and involves the insertion of two needles into the patient — one to extract their blood and one to return it once it has been filtered. However, normal blood vessels cannot tolerate large needles being inserted into them repeatedly. One way to overcome this is to surgically insert a plastic tube between a vein and an artery in the patient's arm ("access graft"). Needles can then be repeatedly inserted into the graft to connect the patient to the dialysis machine.
   
   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 also frequently fails, but more rapidly as less suitable sites are used, 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.
   
   Mechanism of action
   Trinam® is a combination of a vascular endothelial growth factor (VEGF-D) gene packaged in an adenoviral vector (Ad 5) and a bio-degradable local drug delivery device made from collagen and invented by Ark. At the end of access graft surgery, the delivery device is fitted around the outside of the patient's vein where it has been joined to the access graft. The adenoviral vector carrying the VEGF gene is then injected into a space between the device and the blood vessel. This unique administration of the gene to the outside of the blood vessel rather than into the blood supply localises delivery of the gene to the target tissue site (smooth muscle cells) and reduces the risk of unwanted systemic effects. Once the VEGF gene is transfected locally, muscle cells in the vessel wall produce the VEGF protein which triggers the release of beneficial nitric oxide and prostacyclin. Ark has made a novel discovery by showing that the VEGF protein working via these two agents has a protective effect in vivo, keeping blood vessel walls in a healthy state and regulating muscle cell growth to prevent blocking of the vessel.
   
   Development status
   Trinam® has received Orphan Drug Status in the US and in Europe. Ark has received approval from the RAC to conduct a Phase II/III trial in haemodialysis access surgery. The ascending dose Phase II stage of this trial in up to 20 patients is being conducted in the US at Duke University in North Carolina and at hospitals in Miami, Florida and Norfolk, Virginia.
   
   Stefan
2. [verwijderd] 4 juni 2006 19:54

   auteur info

   • [verwijderd]

     Lid sinds: 01 jan 0001

     Laatste bezoek: 01 jan 0001

   • Aanbevelingen

     Ontvangen: 0

     Gegeven: 0

   •    Aantal posts: 0

   En bevestiging dat het idd trinam is
   
   www.gemcris.od.nih.gov/Contents/GC_CL...
   
   Crucell and Ark Therapeutics Extend PER.C6(R) Agreement with Commercial License
   
   LEIDEN, NETHERLANDS -- (MARKET WIRE) -- 01/18/2006 --
   
   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.
   
   Financial details were not disclosed.
   
   About Crucell
   
   Stefan
3. [verwijderd] 4 juni 2006 20:14

   auteur info

   • [verwijderd]

     Lid sinds: 01 jan 0001

     Laatste bezoek: 01 jan 0001

   • Aanbevelingen

     Ontvangen: 0

     Gegeven: 0

   •    Aantal posts: 0

   Hoi Stefan,
   Dank voor de Trinam® (EG004) info.
   
   Ook interessant, maar een stukje verder in onderzoek (Phase IIb completed):
   
   Cerepro™ (EG009) – treatment for brain cancer (malignant glioma)
   
   Cerepro™ is a novel gene-based product for the treatment of patients with operable high grade glioma, a type of malignant brain tumour, given in addition to standard surgery and radiotherapy/chemotherapy. Cerepro™ has completed two safety and efficacy studies, one of which could be considered as a pivotal study. These studies have demonstrated a consistently significant magnitude of effect, almost doubling mean survival time versus standard treatment (tumour removal plus radiotherapy and/or chemotherapy), on average by more than seven months.
   www.arktherapeutics.com/main/index.ph...
   
   Zie ook:
   www.iex.nl/forum/topic.asp?forum=228&...
   gr.
4. [verwijderd] 4 juni 2006 20:23

   auteur info

   • [verwijderd]

     Lid sinds: 01 jan 0001

     Laatste bezoek: 01 jan 0001

   • Aanbevelingen

     Ontvangen: 0

     Gegeven: 0

   •    Aantal posts: 0

   Hoi flosz,
   
   Is zeker ook interessant maar waarschijnlijk niet op basis van PER.C6
   Als je onderstaand artikel bekijkt zul je zien dat ze een andere cellijn gebruiken. Hoewel ik natuurlijk niet kan uitsluiten of ze op PER.C6 zijn overgestapt.
   
   Immonen A, Vapalahti M, Tyynelä K, Hurskainen H, Sandmair A, Vanninen R, et al. AdvHSV-tk gene therapy with intravenous ganciclovir improves survival in human malignant glioma: a randomised, controlled study. Mol Ther 2004; 10: 967-972.
   
   Stefan
5. [verwijderd] 5 juni 2006 16:28

   auteur info

   • [verwijderd]

     Lid sinds: 01 jan 0001

     Laatste bezoek: 01 jan 0001

   • Aanbevelingen

     Ontvangen: 0

     Gegeven: 0

   •    Aantal posts: 0

   Ik had maar zelf weer aktie ondernomen en ARK gemaild of dit inderdaad in fase II was.
   
   Hieronder hun antwoord.
   
   Dear Mr
   
   The product for which we have licensed the PerC6 cell line is Trinam, which is about to conclude recruitment into a Phase II trial. Further details are available on our website.
   Regards
   Martyn Williams
   CFO
   
   Dirk
6. [verwijderd] 1 september 2006 19:22

   auteur info

   • [verwijderd]

     Lid sinds: 01 jan 0001

     Laatste bezoek: 01 jan 0001

   • Aanbevelingen

     Ontvangen: 0

     Gegeven: 0

   •    Aantal posts: 0

   Van Ark Therapeutics Web Intrim results 30/8/2006
   
   Trinam(R)
   
   In the US-based Phase II study in kidney dialysis patients who have undergone
   vascular access graft surgery, enrolment of the high-dose patients and the
   standard care controls is complete. The very promising efficacy results already
   reported with the low-dose treatment have strengthened further in the period,
   with the average graft survival period of low dose patients increasing to 17.8
   months, compared with the 4.5 month average they had previously experienced.
   All five high dose Trinam(R) patients with successfully implanted grafts remain
   open and the average patency period has already reached 8 months, with three
   approaching 12 months. We are therefore optimistic for the success of the high
   dose group. Three out of four of the standard care controls have already
   blocked (average patency 3.3 months). No systemic distribution of the product
   has been found at the high dose and we have previously reported this for the low
   dose.
   
   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.
   
   Ter informatie voor jullie allen.
   
   Mvg Leo
7. [verwijderd] 1 september 2006 19:43

   auteur info

   • [verwijderd]

     Lid sinds: 01 jan 0001

     Laatste bezoek: 01 jan 0001

   • Aanbevelingen

     Ontvangen: 0

     Gegeven: 0

   •    Aantal posts: 0

   Ik heb sinds oktober vorig jaar minstens driemaal gewezen op de tweede licentie van Merck.
   
   Dit is echt één van de belangrijkste feiten in de historie van Crucell, namelijk een bevestiging, dat het productieplatform PerC6 goed is.
   
   Daarbij valt de start van Quinvaxem, een aantal maanden eerder of later, geheel in het niet. Leuk om even een paar jaar ter overbrugging break even te draaien, maar meer niet.
   Break even in liquiditeit wil nog niet zeggen, dat er winst wordt gemaakt.
8. [verwijderd] 1 september 2006 20:04

   auteur info

   • [verwijderd]

     Lid sinds: 01 jan 0001

     Laatste bezoek: 01 jan 0001

   • Aanbevelingen

     Ontvangen: 0

     Gegeven: 0

   •    Aantal posts: 0

   Oudje,
   
   Wat heeft de tweede licentie van Merck te maken met de voortgang bij Ark therapeutics?? Mis ik hier iets?
   
   Mvg Leo
9. [verwijderd] 1 september 2006 22:03

   auteur info

   • [verwijderd]

     Lid sinds: 01 jan 0001

     Laatste bezoek: 01 jan 0001

   • Aanbevelingen

     Ontvangen: 0

     Gegeven: 0

   •    Aantal posts: 0

   Sorry, in het verkeerde draadje geplant!
10. [verwijderd] 5 oktober 2006 00:23

    auteur info

    • [verwijderd]

      Lid sinds: 01 jan 0001

      Laatste bezoek: 01 jan 0001

    • Aanbevelingen

      Ontvangen: 0

      Gegeven: 0

    •    Aantal posts: 0

    2006 Interim Results presentation, 06 September 2006
    
    page 36
    
    Trinam™•Results update -Q4
    FDA meeting -Q4
12. gogogoo 5 oktober 2006 09:52

    auteur info

    • gogogoo

      Lid sinds: 28 feb 2006

      Laatste bezoek: 10 aug 2023

    • Aanbevelingen

      Ontvangen: 1600

      Gegeven: 808

    •    Aantal posts: 6.042

    quote:

    jeroen100 schreef:

    2006 Interim Results presentation, 06 September 2006
    
    page 36
    
    Trinam™•Results update -Q4
    FDA meeting -Q4
    

    Is dit een meeting van de FDA over een evt. goedkeuring van Trinam?
13. gogogoo 5 oktober 2006 10:37

    auteur info

    • gogogoo

      Lid sinds: 28 feb 2006

      Laatste bezoek: 10 aug 2023

    • Aanbevelingen

      Ontvangen: 1600

      Gegeven: 808

    •    Aantal posts: 6.042

    Author: perseazes Send PM Ignore View Profile Recs: 0
    Subject: Re: Does anyone know??? FDA meeting
    Sentiment: Strong Buy
    Posted as a reply to: msg 272 by doggybert2
    
    
    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...
14. gogogoo 8 januari 2007 17:32

    auteur info

    • gogogoo

      Lid sinds: 28 feb 2006

      Laatste bezoek: 10 aug 2023

    • Aanbevelingen

      Ontvangen: 1600

      Gegeven: 808

    •    Aantal posts: 6.042

    quote:

    flosz schreef:

    Hoi Stefan,
    Dank voor de Trinam® (EG004) info.
    
    Ook interessant, maar een stukje verder in onderzoek (Phase IIb completed):
    
    Cerepro™ (EG009) – treatment for brain cancer (malignant glioma)
    
    Cerepro™ is a novel gene-based product for the treatment of patients with operable high grade glioma, a type of malignant brain tumour, given in addition to standard surgery and radiotherapy/chemotherapy. Cerepro™ has completed two safety and efficacy studies, one of which could be considered as a pivotal study. These studies have demonstrated a consistently significant magnitude of effect, almost doubling mean survival time versus standard treatment (tumour removal plus radiotherapy and/or chemotherapy), on average by more than seven months.
    www.arktherapeutics.com/main/index.ph...
    
    Zie ook:
    www.iex.nl/forum/topic.asp?forum=228&...
    gr.
    

    STOCKS NEWS UK-Ark shares extend rise on drug safety boost
    Mon Jan 8, 2007 4:15 PM GMT15
    Email This Article | Print This Article | RSS
    [-] Text [+]
    
    16:15GMT 08Jan2007-Ark shares extend gains on drug safety boost
    
    ----------------------------------------------------------------------------
    
    Shares in Ark Therapeutics (AKT.L: Quote, Profile , Research) continue to rise on the back of the biotech company's announcement last Friday that it was given permission to continue a final Phase III study of its lead product for brain cancer, Cerepro, jumping another 5 percent.
    
    "The news from Friday have now fed through," says a trader. Ark shares have gained more than 8 percent since Thursday.
    
    To read Friday's company statement, click on [ID:nRNSE0258P].
    
    Reuters messaging kerstin.neuber.reuters.com@reuters.net
15. gogogoo 11 januari 2007 10:31

    auteur info

    • gogogoo

      Lid sinds: 28 feb 2006

      Laatste bezoek: 10 aug 2023

    • Aanbevelingen

      Ontvangen: 1600

      Gegeven: 808

    •    Aantal posts: 6.042

    STOCKS NEWS UK-Ark up 8.6 pct on gene therapy progress
    Thu Jan 11, 2007 9:07 AM GMT19
    Email This Article | Print This Article | RSS
    [-] Text [+]
    
    09:00GMT 11Jan2007-Ark up 8.6 pct on gene therapy progress
    
    ---------------------------------------------------------------------------
    
    Shares in biotech firm Ark Therapeutics (AKT.L: Quote, Profile , Research) rise 8.6 percent to 129 pence as it says it has been given permission to take its gene therapy for kidney patients to a Phase III trial and the U.S. Food and Drug Administration says Ark only needs to conduct one trial before a decision on approval is made.
    
    "Whilst we are maintaining our forecast figures we are raising our target price to 138p as a result of the improved risk profile of this product," says Numis Securities in a note.
    
    To see company statement, click on [ID:nRNSK3363P]
    
    Reuters Messaging chris.wills.reuters.com@reuters.net
16. [verwijderd] 11 januari 2007 10:45

    auteur info

    • [verwijderd]

      Lid sinds: 01 jan 0001

      Laatste bezoek: 01 jan 0001

    • Aanbevelingen

      Ontvangen: 0

      Gegeven: 0

    •    Aantal posts: 0

    Ark Therapeutics Grp - Research Update
    RNS Number:3363P
    Ark Therapeutics Group PLC
    11 January 2007
    
    Ark Holds Positive End of Phase II Meeting with FDA on Trinam(R) Gene Therapy
    
    Phase II data accepted and FDA offers Special Protocol Assessment for single
    pivotal Phase III study
    
    11 January 2007 - Ark Therapeutics Group plc ('Ark') today announces that it has
    held a positive 'end of Phase II' meeting with the US Food and Drug
    Administration ('FDA') regarding Trinam(R), its novel gene therapy to prevent
    blood vessels blocking in kidney dialysis patients who have undergone vascular
    access graft surgery.
    
    Key points to emerge from the meeting were that the FDA has agreed that the data
    from the Phase II trial, reported by Ark in August 2006, are sufficient to allow
    progression to Phase III and a single Phase III trial will be acceptable for the
    basis of a marketing approval. Furthermore, the FDA has offered Special
    Protocol Assessment (SPA) for the single pivotal Phase III study for Trinam(R).
    The SPA procedure allows Ark to work directly with the FDA to ensure the design
    of the trial, the definitive clinical objectives and data analyses are optimised
    to support regulatory approval.
    
    The Phase III study is being planned as a multi-centre, randomised, controlled
    trial of up to 250 patients in which the efficacy and safety of Trinam(R) will
    be investigated in patients with end stage renal disease (ESRD) requiring
    vascular access for haemodialysis. Patients with ESRD will be randomised to
    receive either Trinam(R) 4x1010 viral particles in addition to standard care or
    standard care alone at the time of surgical placement of a synthetic PTFE graft
    for vascular access. The primary endpoint of the trial will be the time to graft
    failure.
    
    Ark reported the preliminary results of the ongoing, open-label, standard-care
    controlled Phase II trial in August, with the new data from the trial showing
    that the access grafts of low dose patients remained functional for dialysis on
    average over five times longer (17.8 months) than control patients in the trial
    (3.3 months). At that time, in the high dose group, recruited after the low
    dose group, all patients with successful graft implants had open grafts with
    patency averaging 8 months. For the primary end point of safety, no
    quantifiable systemic distribution of Trinam(R) was found in either of the high
    or low dose groups and the product is well tolerated. No serious side effects
    were exhibited other than those consistent with the nature of the operation and
    condition.
    
    As part of the overall Trinam(R) programme, Ark also announces today that, after
    consultation with the FDA, it intends to undertake a small pre-clinical study on
    Trinam(R), investigating biodistribution in an 'end-to-side' procedure for
    surgical placement of the graft. If the results of this trial are in line with
    expectations, it will allow the Phase III trial to include this procedure
    alongside the 'end-to-end' placement procedure. Pending SPA agreement, the
    Phase III study is expected to commence around mid-2007 and to last for
    approximately 18 months.
    
    Commenting on today's announcement, Dr Nigel Parker, Chief Executive of Ark,
    said:
    
    'The FDA's positive response to the next stage of Trinam(R)'s development,
    particularly its offer of Special Protocol Assessment, confirms our belief in
    the future of this product. We have very encouraging Phase II data on the
    clinical effectiveness of Trinam(R) and believe that Trinam(R) may have a
    valuable role to play in the treatment of kidney failure patients where the
    problem of vascular access blocking is identified in the US Healthy People 2010
    Framework as one of the key medical issues to be resolved. This outcome is in
    line with our budgeted plan and we look forward to giving a further update after
    receiving Special Protocol Assessment and to the commencement of the Phase III
    study.'
    
    For further information:
    
    Ark Therapeutics Group plc Tel: + 44 (0)20 7388 7722
    Dr Nigel Parker, CEO
    Martyn Williams, CFO
    
    Financial Dynamics Tel: +44 (0)20 7831 3113
    David Yates
    Anna Keeble
    
    
17. josti5 11 januari 2007 10:56

    auteur info

    • josti5

      Lid sinds: 23 feb 2005

      Laatste bezoek: 08 feb 2025

    • Aanbevelingen

      Ontvangen: 17886

      Gegeven: 21100

    •    Aantal posts: 34.560

    Knap werk upstream, dank.
18. [verwijderd] 11 januari 2007 10:57

    auteur info

    • [verwijderd]

      Lid sinds: 01 jan 0001

      Laatste bezoek: 01 jan 0001

    • Aanbevelingen

      Ontvangen: 0

      Gegeven: 0

    •    Aantal posts: 0

    Dit moet de koers van Crucell > 20.80 brengen!
    
    sammie
19. josti5 11 januari 2007 11:00

    auteur info

    • josti5

      Lid sinds: 23 feb 2005

      Laatste bezoek: 08 feb 2025

    • Aanbevelingen

      Ontvangen: 17886

      Gegeven: 21100

    •    Aantal posts: 34.560

    Ja, want dat ging snel, die fase II!
    Als III goed doorlopen wordt: introduktie 2008, en het eerste produkt op basis van "Percy6", dat op de markt komt.
20. miekemuis 11 januari 2007 11:11

    auteur info

    • miekemuis

      Lid sinds: 18 mrt 2004

      Laatste bezoek: 12 nov 2024

    • Aanbevelingen

      Ontvangen: 82

      Gegeven: 1002

    •    Aantal posts: 315

    quote:

    BioStefan schreef:

    ....bericht start draadje van 4/6/06
    
    Development status
    Trinam® has received Orphan Drug Status in the US and in Europe...
    
    Stefan
    

    Ja Josti, "fast track" voor "Orphan Drug Status", bewijs is er nu dus, hopelijk gaat laatse fase even "rimpelloos" en "snel".
21. Justabeliever 11 januari 2007 11:48

    auteur info

    • Justabeliever

      Lid sinds: 04 feb 2005

      Laatste bezoek: 08 feb 2025

    • Aanbevelingen

      Ontvangen: 38

      Gegeven: 54

    •    Aantal posts: 95

    quote:

    josti5 schreef:

    Als III goed doorlopen wordt: introduktie 2008

    Niet helemaal denk ik, realistischer lijkt me het volgende tijdpad:
    - start phase III mid 2007 (zie PB Ark)
    - looptijd studie 18 maanden (zie PB Ark)
    - indiening dossier Q2 2009 (schat ik)
    - fast track approval Q4 2009
    
    Uiteindelijk dan op de markt in 2010