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  1. [verwijderd] 10 maart 2011 07:54

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    Biolex to Present Final Phase 2b Results at EASL for Locteron(R) Next-Generation Controlled-Release Interferon for HCV
    Presentations Will Highlight Strong Antiviral Activity and SVR Rates Together With Significant Reductions in Flu-Like Adverse Events and Reduced Rates of Depression

    Significant Tolerability Advantages and a 50% Reduction in Dosing Frequency Support Locteron's Attractiveness for Use in New Triple and Quad Combination Regimens

    PITTSBORO, NC--(Marketwire - March 10, 2011) - Biolex Therapeutics, Inc. announced today that final results from its SELECT-2 Phase 2b trial of Locteron® for the treatment of hepatitis C have been accepted for two presentations on March 31, 2011 at the 46th Annual Meeting of the European Association for the Study of the Liver (EASL) to be held in Berlin, Germany. Locteron, the only controlled-release interferon alpha, is designed to offer at least equal efficacy with key tolerability and dosing advantages over currently marketed interferons as a core component of new combination therapies for hepatitis C. Locteron's observed advantages include significant reductions in flu-like symptoms, reduced rates of depression, and a 50% less-frequent dosing regimen with once every other week dosing.

    Final SELECT-2 study results will be presented for the first time at the EASL conference, including:

    Sustained virologic response (SVR) rates at completion of the trial (week 72), as well as final tolerability comparison results using both traditional clinic visit data and electronic patient reported outcome measures.
    Timing and frequency of depression during the 48 weeks of treatment in SELECT-2. Depression is a serious medical condition that requires careful monitoring during hepatitis C treatment. Favorable Locteron results related to depression rates will be highlighted in a separate presentation during the EASL conference.
    SELECT-2 was a dose-finding study comparing three doses of Locteron versus the PEG-Intron® control arm in 116 treatment-naïve, genotype-1, chronic hepatitis C patients in the United States and Europe (all patients also received weight-based ribavirin). Patients in SELECT-2 were scheduled to be treated for 48 weeks and followed for an additional 24 weeks to determine their SVR rate.

    Interim SELECT-2 results were the subject of multiple presentations at the EASL conference in April 2010 and the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD) conference in November 2010. The interim results supported the expected product profile for Locteron by demonstrating:

    Viral response rates for all Locteron doses that were comparable with or exceeded the response rate for the control group, achieved with half as many injections of Locteron versus the control;
    Statistically and clinically significant reductions in flu-like adverse events for the Locteron cohorts compared to the control group, as high as 60+% reductions;
    Substantially reduced use of concomitant medications (analgesics and antipyretics) for the Locteron cohorts compared to the control group;
    Substantially lower rates of depression for the two Locteron cohorts comprising the expected commercial dose range compared to the control group;
    Lower discontinuations due to adverse events for the two Locteron cohorts comprising the expected commercial dose range compared to the control group.
    "We are pleased that the final results from the SELECT-2 trial have been selected for multiple presentations at this prestigious conference," said Jan Turek, Biolex's President and Chief Executive Officer. "We believe that data presentations highlighting significantly reduced rates of flu-like events and marked reductions in the rates of depression associated with Locteron will be of particular interest as doctors, patients and payors clearly need a far better tolerated interferon as a backbone drug for the new triple and quad combination regimens with DAAs."

    "Without a better tolerated interferon, these new triple and quad combinations will carry huge tolerability challenges that will limit access to care, reduce treatment intent rates and likely cause poor adherence in a real-world setting which we know lowers cure rates and raises the risk of multi-drug resistance," Turek further explained. "Our goal as we move into Phase 3 is to leverage Locteron's clear advantages in tolerability, combinability and dosing to position it along with the best direct-acting anti-virals to set the new standard in combination therapy for hepatitis C."

    Locteron Overview
    Locteron, controlled-release interferon alpha 2b, is designed to offer key advantages compared to currently approved products, including reduced flu-like symptoms and rates of depression, and cutting in half the number of injections required. In contrast to Locteron, the currently approved products, Pegasys® and PEG-Intron, are immediate-release products that lack a controlled-release mechanism. The two-drug combination of interferon alpha and ribavirin serves as the current standard of care for the treatment of hepatitis C. However, the launch of the first direct-acting anti-viral (DAA) product, projected to occur this year, will transform treatment of genotype-1 patients to a triple-drug therapy (interferon plus ribavirin plus DAA) and substantially raise cure rates. Other recent triple or quad drug combinations with interferon (including interferon plus ribavirin plus two DAA agents) have shown promise in early clinical testing, further solidifying the continued role of interferon in the treatment of hepatitis C. It is estimated that worldwide sales of interferon products for the treatment of hepatitis C will approach $6 billion by 2016.

    Locteron incorporates an advanced controlled-release drug delivery technology that allows dosing once every two weeks. This is considerably more convenient than Pegasys and PEG-Intron, each of which requires dosing every week. More importantly, Locteron's controlled-release mechanism results in the gradual release of interferon alpha 2b to patients over the duration of two weeks and avoids the early peak plasma levels of the active interferon that characterize the pegylated interferons. This controlled-release mechanism is designed to reduce the frequency and severity of flu-like symptoms and depression commonly experienced by patients treated with pegylated interferons.

    Locteron is an investigational therapeutic candidate and has not been approved for sale by the United States Food and Drug Administration or by any international regulatory agency.

    About Biolex Therapeutics
    Biolex is a biopharmaceutical company that uses its patented LEX System(SM) to develop follow-on biologics, hard-to-make therapeutic proteins and to optimize monoclonal antibodies. The LEX System is a novel technology that genetically transforms the aquatic plant Lemna to enable the production of biologic product candidates. The company's product candidates are designed to provide best-in-class efficacy/tolerability profiles while incorporating proven mechanisms of action. Biolex's lead product candidate, Locteron®, has completed two Phase 2b clinical trials for the treatment of chronic hepatitis C. Biolex has also developed two other product candidates that capitalize on the benefits of the LEX System. BLX-155 is a direct-acting thrombolytic designed to dissolve blood clots in patients. BLX-301 is a humanized anti-CD20 antibody glyco-optimized for the treatment of non- Hodgkin's B-cell lymphoma and other diseases.

    Contacts:
    Media:
    Tim Brons
    Vida Communication
    415-675-7402
    tbrons@vidacommunication.com

  5. [verwijderd] 10 maart 2011 09:11

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    ter herinnering....

    Hepatitis C — pipeline update

    Over 3% of the world's population is chronically infected with hepatitis C virus (HCV). Chronic hepatitis C (CHC) is a major cause of liver damage, cirrhosis and liver cancer that can lead to liver failure and death. The current standard of care (SOC) is a combination of pegylated interferon with ribavirin (PEG-IFN/RBV), but this only eradicates the virus in approximately 50% of patients1.
    The recently concluded sixty-first annual meeting of the American Association for the Study of Liver Diseases (AASLD) provided a broad overview of the pipeline of novel drugs for the treatment of CHC2. It is clear that this field is on the brink of significant improvements to the SOC that should follow the highly anticipated approval of the first direct-------- antiviral agents (DAAs), telaprevir (Vertex/Johnson & Johnson/Mitsubishi) and boceprevir (Merck), in 2011------

    Session Title: Category 08c: Viral Hepatitis C: Clinical (therapy)
    Presentation Date: 31 MAR, 2011
    SVR FOR CONTROLLED-RELEASE INTERFERON ALPHA-2B (CR2B) +RIBAVIRIN COMPARED TO PEGYLATED INTERFERON ALPHA-2B (PEG2B) +RIBAVIRIN IN TREATMENT-NAïVE GENOTYPE-1 (G1) HEPATITIS C: FINAL RESULTS FROM SELECT-2

    Results: 116 patients were enrolled: 61% male, 83% Caucasian, mean baseline HCV RNA 6.1 Log10 , 66% HCV RNA 800,000 IU/mL, 47% G1b, 30% advanced fibrosis (F3-F4), mean age 46, and mean BMI 26.1. Interim safety and efficacy results presented last year (all patients through Week 36) showed dose-related reductions in flu adverse events with comparable efficacy and safety except for excess Grade 2/3 (but not Grade 4) neutropenia on the two higher doses of CR2b (E. Lawitz et al., EASL 2010). Patient disposition through June 20, 2010 (all patients through Week 48) is shown below
    Conclusions: CR2b, previously shown to provide dose-related reductions in flu symptoms, and recently shown to provide dose-related reductions in depression (data submitted, W.A. Long et al., EASL 2011), has at least equal rates efficacy at all three doses tested with half the number of injections of PEG2b. CR2b may offer an important option for future combination therapy of HCV
    www1.easl.eu/easl2011/program/Posters...
  6. [verwijderd] 10 maart 2011 15:37

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    insiders transactie......

    Datum Naam Transactie Aantal Prijs Tot. waarde
    23/12/10 J.H. Egberts
    Aank. aandelen 127.119 1,180 EUR 150.000,42 EUR
    23/12/10 N.D. de Ruiter
    Intekening 127.119 1,180 EUR 150.000,42 EUR
    12/05/10 N.D. de Ruiter
    Toekenning aandelen 500.000 0,000 EUR 0,00 EUR
    10/08/09 J.J.M. Holthuis
    Verk. aandelen 4.180 1,560 EUR 6.520,80 EUR
    10/08/09 J.J.M. Holthuis
    Verk. aandelen 1.100 1,550 EUR 1.705,00 EUR
    07/08/09 J.J.M. Holthuis
    Verk. aandelen 3.900 1,550 EUR 6.045,00 EUR
    07/08/09 J.J.M. Holthuis
    Verk. aandelen 6.000 1,520 EUR 9.120,00 EUR
    07/08/09 J.J.M. Holthuis
    Verk. aandelen 295 1,520 EUR 448,40 EUR
    26/06/09 J.J.M. Holthuis
    Verk. aandelen 1.000 1,420 EUR 1.420,00 EUR
    25/06/09 J.J.M. Holthuis
    Verk. aandelen 5.000 1,490 EUR 7.450,00 EUR
    23/06/09 J.J.M. Holthuis
    Verk. aandelen 7.500 1,430 EUR 10.725,00 EUR
    23/06/09 J.J.M. Holthuis
    Verk. aandelen 500 1,440 EUR 720,00 EUR
    23/06/09 J.J.M. Holthuis
    Verk. aandelen 590 1,450 EUR 855,50 EUR
    23/06/09 J.J.M. Holthuis
    Verk. aandelen 40 1,470 EUR 58,80 EUR
    23/06/09 J.J.M. Holthuis
    Verk. aandelen 2.460 1,440 EUR 3.542,40 EUR
    23/06/09 J.J.M. Holthuis
    Verk. aandelen 5.000 1,460 EUR 7.300,00 EUR
    22/06/09 J.J.M. Holthuis
    Verk. aandelen 200 1,440 EUR 288,00 EUR
    19/06/09 J.J.M. Holthuis
    Verk. aandelen 2.340 1,440 EUR 3.369,60 EUR
    18/06/09 J.J.M. Holthuis
    Verk. aandelen 3.500 1,380 EUR 4.830,00 EUR
    18/06/09 J.J.M. Holthuis
    Verk. aandelen 3.500 1,440 EUR 5.040,00 EUR
    18/06/09 J.J.M. Holthuis
    Verk. aandelen 2.000 1,450 EUR 2.900,00 EUR
    18/06/09 J.J.M. Holthuis
    Verk. aandelen 5.000 1,470 EUR 7.350,00 EUR
    12/06/09 J.J.M. Holthuis
    Verk. aandelen 2.120 1,460 EUR 3.095,20 EUR
    11/06/09 J.J.M. Holthuis
    Verk. aandelen 5.000 1,450 EUR 7.250,00 EUR
    10/06/09 J.J.M. Holthuis
    Verk. aandelen 880 1,460 EUR 1.284,80 EUR
    09/06/09 J.J.M. Holthuis
    Verk. aandelen 4.700 1,480 EUR 6.956,00 EUR
    08/06/09 J.J.M. Holthuis
    Verk. aandelen 2.792 1,430 EUR 3.992,56 EUR
    05/06/09 J.J.M. Holthuis
    Verk. aandelen 120 1,485 EUR 178,20 EUR
    05/06/09 J.J.M. Holthuis
    Verk. aandelen 90 1,480 EUR 133,20 EUR
    05/06/09 J.J.M. Holthuis
    Verk. aandelen 6.047 1,500 EUR 9.070,50 EUR
    05/06/09 J.J.M. Holthuis
    Verk. aandelen 2.000 1,490 EUR 2.980,00 EUR
    05/06/09 J.J.M. Holthuis
    Verk. aandelen 3.300 1,500 EUR 4.950,00 EUR
    03/06/09 J.J.M. Holthuis
    Verk. aandelen 200 1,500 EUR 300,00 EUR
    03/06/09 J.J.M. Holthuis
    Verk. aandelen 1.700 1,480 EUR 2.516,00 EUR
    03/06/09 J.J.M. Holthuis
    Verk. aandelen 3.300 1,480 EUR 4.884,00 EUR
    03/06/09 J.J.M. Holthuis
    Verk. aandelen 100 1,520 EUR 152,00 EUR
    03/06/09 J.J.M. Holthuis
    Verk. aandelen 2.400 1,520 EUR 3.648,00 EUR
    03/06/09 J.J.M. Holthuis
    Verk. aandelen 3.000 1,510 EUR 4.530,00 EUR
    03/06/09 J.J.M. Holthuis
    Verk. aandelen 781 1,500 EUR 1.171,50 EUR
    03/06/09 J.J.M. Holthuis
    Verk. aandelen 500 1,530 EUR 765,00 EUR
    03/06/09 J.J.M. Holthuis
    Verk. aandelen 75 1,540 EUR 115,50 EUR
    03/06/09 J.J.M. Holthuis
    Aank. aandelen 200 1,500 EUR 300,00 EUR
    03/06/09 J.J.M. Holthuis
    Aank. aandelen 1.700 1,480 EUR 2.516,00 EUR
    03/06/09 J.J.M. Holthuis
    Aank. aandelen 3.300 1,480 EUR 4.884,00 EUR
    03/06/09 J.J.M. Holthuis
    Aank. aandelen 100 1,520 EUR 152,00 EUR
    03/06/09 J.J.M. Holthuis
    Aank. aandelen 2.400 1,520 EUR 3.648,00 EUR
    03/06/09 J.J.M. Holthuis
    Aank. aandelen 3.000 1,510 EUR 4.530,00 EUR
    03/06/09 J.J.M. Holthuis
    Aank. aandelen 781 1,500 EUR 1.171,50 EUR
    03/06/09 J.J.M. Holthuis
    Aank. aandelen 500 1,530 EUR 765,00 EUR
    03/06/09 J.J.M. Holthuis
    Aank. aandelen 75 1,540 EUR 115,50 EUR
    28/05/09 J.J.M. Holthuis
    Verk. aandelen 4.751 1,500 EUR 7.126,50 EUR
    28/05/09 J.J.M. Holthuis
    Verk. aandelen 1.100 1,510 EUR 1.661,00 EUR
    28/05/09 J.J.M. Holthuis
    Verk. aandelen 500 1,530 EUR 765,00 EUR
    28/05/09 J.J.M. Holthuis
    Verk. aandelen 75 1,540 EUR 115,50 EUR
    25/02/09 S.J. Sturge
    Aank. aandelen 133.333 12,000 EUR 1.599.996,00 EUR
    06/11/08 G. Moolhuizen
    Toekenning aandelen 22.500 0,000 EUR 0,00 EUR
  8. forum rang 10 voda 10 maart 2011 16:00

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    OctoPlus partner presenteert eindresultaten Fase IIb Locteron


    AMSTERDAM (Dow Jones)--OctoPlus nv's (OCTO.AE) licentiepartner Biolex zal de eindresultaten van een Fase IIb studie voor medicijn Locteron presenteren tijdens een congres in Berlijn op 31 maart.

    Twee abstracts van licentiepartner Biolex Therapeutics zijn geaccepteerd voor presentatie, aldus het biofarmaceutische bedrijf uit Leiden donderdag.

    Locteron is een langerwerkende formulering van interferon alfa voor de behandeling van chronische hepatitis C. In 2008 licenseerde OctoPlus zijn deel van de commerciele rechten op Locteron exclusief aan Biolex.


    Door Ben Zwirs, Dow Jones Nieuwsdienst; +31-20-5715 210, ben.zwirsr@dowjones.com

  10. patient 10 maart 2011 19:02

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    De woorden van Jan Turek (Biolex) zijn veelbelovend:

    "Without a better tolerated interferon, these new triple and quad combinations will carry huge tolerability challenges that will limit access to care, reduce treatment intent rates and likely cause poor adherence in a real-world setting which we know lowers cure rates and raises the risk of multi-drug resistance," Turek further explained. "Our goal as we move into Phase 3 is to leverage Locteron's clear advantages in tolerability, combinability and dosing to position it along with the best direct-acting anti-virals to set the new standard in combination therapy for hepatitis C."

    Het is als het ware een aanzoek tot Vertex
  11. [verwijderd] 10 maart 2011 19:33

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    "Zonder een beter verdragen interferon, zullen deze nieuwe triple-en quad combinaties uitvoeren enorme tolerantie uitdagingen die de toegang tot zorg, te verminderen behandeling intentie tarieven en waarschijnlijke oorzaak slechte therapietrouw in een echte wereld waarvan we weten dat verlaagt genezingspercentage en verhoogt het risico zal beperken van multi-drug resistentie, "Turek nader toegelicht. "Ons doel als we verhuizen naar Fase 3 is bedoeld om duidelijke voordelen benutten van Locteron in de tolerantie, combineerbaarheid en doseren om het standpunt samen met de beste direct werkende antivirale middelen aan de nieuwe standaard in combinatietherapie voor hepatitis C."

    tja dit betekend volgens mij ook de overgang naar faseIII,
    hangt hier een milestone betaling aan?
  12. patient 11 maart 2011 09:41

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    quote:

    Kopenmaar! schreef op 10 maart 2011 19:33:

    tja dit betekend volgens mij ook de overgang naar faseIII,
    hangt hier een milestone betaling aan?

    Jazeker, zodra Biolex een samenwerkingscontract heeft gesloten met partner die financieel participeert in ontwikkeling Locteron.
  13. mr.Franz 11 maart 2011 10:13

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    flinke dump

    Tijd Volume Prijs
    10:10:25 4.424 1,240
    10:09:35 576 1,240
    10:09:35 920 1,240
    10:09:35 2.000 1,245
    10:09:35 2.700 1,252
    10:09:35 2.300 1,252
    10:09:35 1.000 1,253
    10:09:35 504 1,270
    10:05:57 996 1,270
    09:39:33 1.000 1,270
    09:31:55 1.000 1,270
    09:00:00 500 1,295

    Bestuurders die eruit stappen?
  15. mr.Franz 11 maart 2011 10:27

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    quote:

    PATERPLUS schreef op 11 maart 2011 10:24:

    Het is de club van Whippet, de koers wordt weer lager gezet omdat er weinig tot geen handel plaats vind.
    De club van Whippet?

    En wie heeft er op dit moment belang bij om de koers weer lager te zetten. Had ook met minder stukjes gekund zoals eerder deze maand soms gebeurde met 4 stks.

    Bied boekje ziet er niet echt vertrouwenswekkend uit.
  17. mr.Franz 11 maart 2011 11:34

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    quote:

    patient schreef op 11 maart 2011 10:38:

    Dit is een paniek verkoop. Men is bang voor natte voeten ivm Tsunami.
    valt iets van te zeggen

    in 1995 vondt de laatste grote aardbeving plaats:

    De zuivere grootte van de aardbeving veroorzaakte een belangrijke daling in Japanse effectenbeurzen, met Nikkei 225 index het werpen zich door duizend punten in één dag na de schok. Deze financiële schade was de belangrijkste oorzaak voor de instorting van De Bank van Barings wegens de acties van Inkeping Leeson, die enorme hoeveelheden geld op Japanse en Singaporean derivaten had gespeculeerd.

    www.worldlingo.com/ma/enwiki/nl/Great...
  18. flosz 1 april 2011 10:40

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    Poster Presented at EASL.

    Timing and Frequency of Depression During HCV-Treatment
    with Controlled Release IFNa2b (CR2b) vs. Pegylated IFNa2b
    (PEG2b): Results from SELECT-2, a Randomized Open-label
    72-Week Comparison in 116 Treatment-Naïve Patients with Genotype 1 HCV
    www.biolex.com/pdfs/Biolex%20Locteron...

    SVR for Controlled-release Interferon Alpha-2B (CR2b)
    +Ribavirin Compared to Pegylated Interferon Alpha-2B
    (PEG2b) +Ribavirin in Treatment-naïve Genotype-1 (G1)
    Hepatitis C: Final Results from SELECT-2
    www.biolex.com/pdfs/Biolex%20Locteron...
  19. [verwijderd] 1 april 2011 17:16

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    quote:

    flosz schreef:

    Poster Presented at EASL.

    Timing and Frequency of Depression During HCV-Treatment
    with Controlled Release IFNa2b (CR2b) vs. Pegylated IFNa2b
    (PEG2b): Results from SELECT-2, a Randomized Open-label
    72-Week Comparison in 116 Treatment-Naïve Patients with Genotype 1 HCV
    www.biolex.com/pdfs/Biolex%20Locteron...

    SVR for Controlled-release Interferon Alpha-2B (CR2b)
    +Ribavirin Compared to Pegylated Interferon Alpha-2B
    (PEG2b) +Ribavirin in Treatment-naïve Genotype-1 (G1)
    Hepatitis C: Final Results from SELECT-2
    www.biolex.com/pdfs/Biolex%20Locteron...

    Flosz,
    Ik wil je graag bedanken voor je bijdrage in dit forum,, doet mij goed om je ook hier actief te zien. na alles wat je hebt gedaan in het Crucell forum
    Hartelijke groeten,Jan941
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Archos 1 1
Arcona Property Fund 1 287
arGEN-X 17 10.378
Aroundtown SA 1 221
Arrowhead Research 5 9.758
Ascencio 1 30
ASIT biotech 2 697
ASMI 4.108 39.697
ASML 1.767 112.107
ASR Nederland 21 4.522
ATAI Life Sciences 1 7
Atenor Group 1 522
Athlon Group 121 176
Atrium European Real Estate 2 199
Auplata 1 55
Avantium 32 14.334
Axsome Therapeutics 1 177
Azelis Group 1 67
Azerion 7 3.463

Macro & Bedrijfsagenda

  1. 11 april

    1. Faillissementen, maart (NL)
    2. Inflatie, maart (Dld)
    3. Industriële productie, februari (VK)
    4. Handelsbalans, februari (VK)
    5. Ahold Delhaize €0,67 ex-dividend
    6. SBM Offshore ex-dividend €0,85 (bepaald op AGM 9 april)
    7. JPMorgan Chase, cijfers eerste kwartaal
    8. Morgan Stanley, cijfers eerste kwartaal
    9. Wells Fargo, cijfers eerste kwartaal
    10. BlackRock, cijfers eerste kwartaal
de volitaliteit verwacht indicator betekend: Market moving event/hoge(re) volatiliteit verwacht
Naar de hele agenda