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Xoma

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  1. [verwijderd] 8 juni 2009 22:45
    Slot: +11,3%

    En vers van de pers.

    Onderzoek bij muizen, maar de resultaten zijn bijzonder.
    Is ter adstructie bij het onderzoek van het weekend.

    XOMA Presents Data At ADA Demonstrating Improvement in Diabetes and Inflammatory Measures in Animal Model With XOMA 052

    BERKELEY, Calif., Jun 8, 2009 (GlobeNewswire via COMTEX News Network) -- XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, announced the presentation of new preclinical results with XOMA 052 in the diet-induced obesity mouse model. XOMA 052 addresses the inflammatory cause of Type 2 diabetes by targeting interleukin 1 beta (IL-1 beta), a master signaling protein which triggers inflammatory pathways. The results were presented at the American Diabetes Association (ADA) 69th Scientific Sessions in New Orleans, Louisiana.

    "The diet-induced obesity model is a validated tool for evaluating the role of IL-1 in Type 2 diabetes that mimics the development of the disease in humans more closely than genetic or chemically-induced models," said Stephen K. Doberstein, Ph.D., XOMA's Vice President of Research. "The data reported today clearly show the potential for XOMA 052 to improve glucose control, beta cell function and survival, and insulin resistance without contributing to weight gain. XOMA 052 also corrected the dyslipidemia associated this diabetes model, suggesting the potential for cardiovascular benefit."

    Groups of mice received either a normal diet or a high fat/high sucrose diet and twice-weekly doses of XOMA 052 or an isotype control for 12 to 14 weeks. This study design enabled evaluation of XOMA 052 in both normal and simulated diabetic conditions. At the end of the study period, mice that received XOMA 052 and the high fat/high sucrose diet showed, as compared to control (mice receiving isotype control and on high fat/high sucrose diet), statistically significant:

    * Reduction in glycosylated hemoglobin (HbA1c) levels
    * Reduction in fasting blood glucose without causing hypoglycemia
    * Improvement in glucose control
    * Improvement in insulin secretion and beta cell function
    * Protection from diet-induced beta cell apoptosis
    * Increase in beta cell proliferation
    * Reduction in total cholesterol without reduction in high
    density lipoprotein
    * Reduction in triglycerides and free fatty acids

    P.
  2. spyfly 15 juni 2009 20:37
    quote:

    Bassie schreef:

    RT 1,07 gaat opeens omhoog. Enig idee? Kan nergens nieuws vinden.
    Geen idee, maar daalt weer wat nu, flinke koper?
  3. [verwijderd] 26 juni 2009 22:16
    quote:

    1gustaaf schreef:

    ja, bij diverse bio's vanavond aan eind forse aan- en verkopen. Kan voor xoma nog geen aanleiding vinden.
    G

    Xoma is uit de Russell gegooid...........

    P.
  4. gustaaf1e 26 juni 2009 22:18
    quote:

    psycho-pharma schreef:

    [quote=1gustaaf]
    ja, bij diverse bio's vanavond aan eind forse aan- en verkopen. Kan voor xoma nog geen aanleiding vinden.
    G

    [/quote]

    Xoma is uit de Russell gegooid...........

    P.
    hm..
    G
  5. [verwijderd] 14 juli 2009 22:42
    Ik dacht al, het stijgt zo maar 7% en op hoog volume........

    Jawel enige voorkennis van een PB.

    Zeer interessant voor diabetes II:

    XOMA Announces Positive Results From U.S. Phase 1 Trial of XOMA 052 in Type 2 Diabetes

    Jul 14, 2009 (GlobeNewswire via COMTEX News Network) --

    Results Support Initiation of Phase 2 Program With Multiple Dose
    Subcutaneous Regimen

    Conference Call and Webcast At 4:30 pm ET Today

    BERKELEY, Calif., July 14, 2009 (GLOBE NEWSWIRE) -- XOMA Ltd. (Nasdaq:XOMA), a leader in the discovery and development of therapeutic antibodies, today announced positive results from single dose and multiple dose subcutaneous arms of the randomized, placebo-controlled U.S. Phase 1 clinical trial of XOMA 052 in Type 2 diabetes patients. Of the 98 patients evaluated in different parts of the Phase 1 clinical trial, XOMA is reporting today on the 26 patients who received active drug in both single and multiple doses by subcutaneous route of administration and all 17 placebo patients. The results continue to demonstrate that XOMA 052 is well tolerated in patients. Further, a multiple dose regimen of XOMA 052 showed clinically meaningful reductions in glycosylated hemoglobin, HbA1c, and high sensitivity C-reactive protein, hsCRP, compared to a single dose regimen. Generally, a more consistent response was seen across patients in the multiple dose regimen compared to single dose regimen. New positive biological activity was observed with sustained improvements noted in fasting blood glucose, with a reduction of 29 mg/dL at day 84, equating to approximately a 1% reduction in HbA1c, and standard biomarkers of systemic inflammation and cardiovascular risk. Pharmacokinetic results continue to support monthly or less frequent dosing and drug bioavailability in patients by subcutaneous injection was 62-70% compared to IV administration. These Phase 1 results support XOMA's plan to begin Phase 2 testing of XOMA 052 in Type 2 diabetes in the current quarter.

    As important, this is the first study of an IL-1 targeting agent to demonstrate evidence of improved insulin sensitivity. An increase in insulin production was previously reported in earlier studies with XOMA 052, suggesting an additional benefit in diabetes patients.

    The growing body of evidence for XOMA 052's anti-inflammatory effects also supports its potential in cardiovascular and other inflammatory diseases. Published studies show that IL-1 beta plays a key role in the initiation, growth and instability of plaque leading to heart attacks and other cardiovascular events.

    "An anti-inflammatory approach to Type 2 diabetes and other cardiometabolic diseases is a potential breakthrough for treating these very common medical conditions," said Marc Y. Donath, M.D., a pioneer in anti-inflammatory approaches to Type 2 diabetes, Professor at the University Hospital of Zurich and XOMA 052 Swiss clinical trial principal investigator. "These results confirm previous XOMA 052 findings in reducing inflammatory biomarkers and improving glycemic control. For the first time, they demonstrate the potential for XOMA 052 to break the vicious cycle of glucotoxicity by improving insulin sensitivity and restoring beta cell health through IL-1 beta regulation."

    "We remain very excited about the data generated thus far from this Phase 1 program, including important new evidence of biological activity. Moreover, we are seeing these activities at a very low dose, at least ten times lower than many approved monoclonal antibodies," said Steven B. Engle, XOMA's Chairman and Chief Executive Officer. "While this Phase 1 trial has achieved its primary purpose of providing valuable safety and pharmacokinetic information, we are delighted to have seen the first evidence of improved insulin sensitivity as well as improvements in other biomarkers associated with Type 2 diabetes and cardiovascular disease. When combined with our previously reported results of improved insulin production, we believe XOMA 052 has demonstrated the potential to address two important arms of the diabetes disease process: insulin production and peripheral insulin sensitivity."

    This is the first time XOMA is reporting data regarding the subcutaneous (SC) administration of multiple doses and single doses of XOMA 052 in Type 2 diabetes patients. Previously XOMA reported positive results from a study evaluating the intravenous (IV) administration of a single dose of XOMA 052 at different dose levels. The SC route of administration is particularly important for treating chronic diseases such as Type 2 diabetes.

    "In the 0.03 mg/kg multiple dose cohort, we observed median reductions of over 50% in CRP and up to 0.6% in HbA1c at day 56, as well as rapid, meaningful and prolonged reductions in fasting blood glucose," said Patrick J. Scannon, M.D., Ph.D., XOMA's Executive Vice President and Chief Medical Officer. "Taken together, these data demonstrate, as expected, the potential for added benefit with multi-dose treatment using XOMA 052. In addition, the 0.03 mg/kg multiple dose median reduction of over 50% in CRP and up to 0.6% in HbA1c at day 56 compares favorably to reductions of 29% and 0.3%, respectively, for a single 0.1 mg/kg dose at the same time point. More patients responded to the multiple dose regimen as well. The bioavailability and pharmacokinetic results enable us to initiate our Phase 2 program using XOMA 052 in monthly or less frequent subcutaneous dose regimens."

    XOMA 052 targets interleukin-1 beta (IL-1 beta), a master signaling protein that triggers auto-inflammatory pathways in the body and is believed to be an underlying cause of cardiometabolic diseases including Type 2 diabetes and cardiovascular disease.

    A summary of the Phase 1 clinical trial design and detailed results follows.

    Phase 1 Clinical Trial Design

    The U.S. Phase 1 study enrolled 68 Type 2 diabetes patients and had three parts: multiple dose by subcutaneous injection; single dose by subcutaneous injection; and single dose by intravenous injection. Each dose level group included one patient who received standard of care plus placebo and five patients who received standard of care plus XOMA 052. Of the 98 patients enrolled in the Phase 1 studies, a total of 81 patients have been dosed with XOMA 052 along with 17 placebo patients, which includes patients treated in a Swiss intravenous Phase 1 trial with the same entry criteria as the U.S. trial.

    In the multi-dose regimen, the doses given were 0.03 and 0.3 milligrams per kilogram of body weight (mg/kg) and they were three times two weeks apart. In the single dose subcutaneous regimen, the doses were 0.03, 0.1 and 0.3 mg/kg doses. Patients on the multi-dose regimen were followed for 84 days including 56 days after their last dose. Patients on the single dose regimens were followed for 56 days.

    In designing the multiple dose study, the decision to dose every 2 weeks and give three doses was driven by pharmacokinetic information requirements to design the Phase 2 study. It is expected that XOMA 052 can be given every other month or less frequently. The 84 day length of the study was chosen to capture the nearer-term results. Of course, a longer study in Phase 2 may show additional benefits as we do not know how far the increase in some of the benefits extends.

    In the multiple dose study, a tenfold range of doses was chosen for safet
  6. [verwijderd] 15 juli 2009 16:17
    quote:

    tonpa schreef:

    Wonderbaarlijke manipulatie.
    Beetje verdrietig is het wel als je gisteren de koers nabeurs zag.
    Ach, aandelen lenen kost bijna niks, een paar naked erbij en de koers gaat wel omlaag......

    P.
  7. [verwijderd] 15 juli 2009 16:31
    Toch vind ik het wel jammer.
    Stond eerst zo mooi boven de dollar. Verwachtte hem toch weer die richting na bericht gisteren.
    Morgen op vakantie.
    Wie weet bij terugkomst........vakantie terugverdiend.......
  8. [verwijderd] 15 juli 2009 16:38
    quote:

    tonpa schreef:

    Wie weet bij terugkomst........vakantie terugverdiend.......
    Dat zou zo maar eens kunnen.

    Ik verwacht toch minimaal een partner of zelfs een buy-out voor -52 voordat de zomer voorbij is.

    Want het principe van -52 is geldig voor rheuma, sarcoidose, you name it.

    P.

  9. [verwijderd] 15 juli 2009 22:06
    quote:

    junkbond schreef:

    [quote=psycho-pharma]
    [quote=junkbond]
    Ik heb gekocht vandaag op 0,7571
    [/quote]

    Attaboy!!

    P.
    [/quote]Wat ? :-)
    = goed gedaan jochie!

    P.
    schrikt nooit van complimenten
  10. [verwijderd] 28 juli 2009 22:17
    Wat is er voor nieuws van Xoma? Ik kan niets vinden op hun site. Ik ben er wel blij mee, daar ik er nogal wat heb. Ik sta nu ruim 1% in de plus. Dat is wel even anders geweest. Ik heb ze heel wat keer gehad afgelopen jaar, lekker aan verdiend maar was weer wat te snel met een verse voorraad aan te schaffen. Ik hoop dat ze nog een beetje doorstijgen, maar het is ook wel leuk om de rede te weten van de stijging.
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