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KERX Keryx Biopharmaceuticals Inc

118 Posts
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  1. [verwijderd] 5 december 2009 10:48

    Source: > 05 December 2009 (E-Business)

    www.bharatbook.com : Keryx Biopharmaceuticals Financial and Strategic Analysis Review
    www.bharatbook.com included a new report on “Keryx Biopharmaceuticals Financial and Strategic Analysis Review” into its market report catalogue for reselling.

    Keryx Biopharmaceuticals, Inc. (Keryx) is a biopharmaceutical company engaged in the acquiring, developing and commercializing products for the treatment of Endocrine/Renal, Neurology and Oncology. The company product pipeline includes Sulonex, Zerenex, KRX-0401, KRX-0402, KRX-0404, KRX-0501, KRX-0601 and KRX-0701. The company principally operates in the US. The company is headquartered in New York, United States and employs 50 people.

    Global Markets Direct, the leading business information provider, presents an in-depth business, strategic and financial analysis of Keryx Biopharmaceuticals. The report provides a comprehensive insight into the company, including business structure and operations, executive biographies and key competitors. The hallmark of the report is the detailed strategic analysis and Global Markets Direct’s views on the company.

    Scope

    -The company’s strengths and weaknesses and areas of development or decline are analyzed. Financial, strategic and operational factors are considered.
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    -The report contains critical company information – business structure and operations, the company history, major products and services, key competitors, key employees and executive biographies, different locations and important subsidiaries.
    -It provides detailed financial ratios for the past five years as well as interim ratios for the last four quarters.
    -Financial ratios include profitability, margins and returns, liquidity and leverage, financial position and efficiency ratios.

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  2. [verwijderd] 7 december 2009 14:37
    Keryx Biopharmaceuticals, Inc. Reports Updated Phase 1/2 Data, Including New Survival Data, on KRX-0401 (Perifosine) in the Treatment of Advanced Multiple Myeloma at the 51st Annual Meeting of the American Society of Hematology
    Response Rate Increases to 41% and Median Overall Survival Reported at 25 Months for All Evaluable Patients

    * Press Release
    * Source: Keryx Biopharmaceuticals, Inc.
    * On 8:30 am EST, Monday December 7, 2009


    *
    Companies:
    o Aeterna Zentaris Inc.
    o Keryx Biopharmaceuticals Inc.

    NEW YORK, Dec. 7 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX - News) today announced updated efficacy and safety data as well as new survival data on the clinical activity of KRX-0401 (perifosine) in combination with bortezomib (Velcade®) (+/- dexamethasone) in patients with relapsed/refractory multiple myeloma. Data from the study entitled "A Multicenter Phase 1/2 Study Evaluating the Safety and Efficacy of Perifosine (KRX-0401) + Bortezomib (Velcade®) in Patients with Relapsed or Relapsed / Refractory Multiple Myeloma Who Were Previously Treated with Bortezomib," was presented on Saturday, December 5th at the 51st annual meeting of the American Society of Hematology, in a poster presentation by Dr. Paul Richardson, Clinical Director of the Jerome Lipper Multiple Myeloma Center, Dana-Farber Cancer Institute.
    Related Quotes
    Symbol Price Change
    AEZS 1.12 0.00
    Chart for AEterna Zentaris, Inc.
    {"s" : "aezs,kerx","k" : "c10,l10,p20,t10","o" : "","j" : ""}

    Dr. Richardson presented updated results from the study as follows:

    Trial Results:

    Eighty-four patients with relapsed/refractory multiple myeloma were enrolled in a combined Phase 1/2 study (18 patients in the Phase 1 component and 66 patients in the Phase 2 component). The patients enrolled were heavily pre-treated with a median of 5 prior lines of therapy (range 1 - 13), including;

    * 100% of patients had been treated with bortezomib (55% of the patients were previously treated with at least two bortezomib-based therapies (range 1 - 4) and 81% were previously treated with bortezomib plus dexamethasone);
    * 98% of patients were previously treated with dexamethasone;
    * 94% of patients were previously treated with lenalidomide (Revlimid®) and/or thalidomide (Thalomid®); and
    * 58% of patients had prior stem cell transplant.

    Overall Response Rate (ORR), defined as the percentage of patients achieving a complete, partial or minor response (CR, PR or MR), was the primary endpoint, with Time to Progression (TTP), Progression-Free Survival (PFS), Overall Survival (OS) and Safety as secondary endpoints.

    Seventy-three patients were evaluable for efficacy. Evaluable patients are defined as those patients who had received at least two cycles of therapy on the combination of perifosine with bortezomib. Of the 73 evaluable patients, 53 patients (73%) were previously refractory to bortezomib (defined as progression on or within 60 days of treatment to a bortezomib-based regimen), including 44 patients who were refractory to the combination of bortezomib + dexamethasone. Twenty evaluable patients (27%) were relapsed to a prior bortezomib-based regimen. Best response for all 73 evaluable patients was as follows:

    Evaluable
    Patients CR /nCR* PR MR ORR SD**
    --------- -------- -------- ------- ------- -------
    All Evaluable
    Patients
    (n=73) 3 4% 13 18% 14 19% 30 41% 30 41%
    ------------- --- --- --- --- --- --- --- --- --- ---
    Bortezomib
    Relapsed
    (n=20) 2 10% 7 35% 4 20% 13 65% 7 35%
    ---------- --- --- --- --- --- --- --- --- --- ---
    Bortezomib
    Refractory
    (n=53) 1 2% 6 11% 10 19% 17 32% 23 43%
    ---------- --- --- --- --- --- --- --- --- --- ---

    * nCR = Near Complete Response is defined as meeting the criteria
    for CR (non-detectable monoclonal protein by serum and urine),
    except with detectable monoclonal protein by immunofixation.
    ** SD = Stable Disease for a minimum of 3 months.

    Approximately 60% (45 / 73) of patients demonstrated progression (or SD for 4 cycles) at some point in their treatment and received 20 mg dexamethasone, four times per week, in addition to perifosine plus bortezomib. Responses occurred both with patients taking perifosine in combination with bortezomib and with patients receiving the combination plus dexamethasone. Best response for each group was as follows:

    Best Response CR /nCR PR MR ORR* SD*
    ------------- ------- -------- ------- ------- -------
    Perifosine +
    Bortezomib (n=73) 2 3% 10 14% 6 8% 18 25% 19 26%
    ----------------- --- --- --- --- --- --- --- --- --- ---
    Dexamethasone added
    (n=45) 1 2% 6 13% 10 23% 17 38% 14 31%
    ------------------- --- --- --- --- --- --- --- --- --- ---

    * 5 patients achieved an initial response on Perifosine +
    Bortezomib alone, and subsequently responded again with the addition
    of Dexamethasone. 3 additional patients achieved stable disease on
    Perifosine + Bortezomib alone, and subsequently achieved stable
    disease again with the addition of Dexamethasone.

    Reported for the first time was median Progression-Free Survival (PFS) and Overall Survival (OS) data for all evaluable patients, as follows:

    Evaluable Patients Median PFS* Median OS**
    ------------------ ----------- -----------

    6.4 months 25 months
    All Evaluable Patients ---------- ---------
    (n=73) 95% CI (5.3, 7.1) 95% CI (15.5, NR)
    ---------------------- ----------------- -----------------

    NR = Not Reached
    * Median PFS and median TTP were identical, as no patient deaths
    occurred prior to progression.
    ** Kaplan Meier methodology was used to determine overall survival
    figures.

    Of particular interest was the comparison of evaluable patients who were previously refractory and the patients who were relapsed to a bortezomib-based regimen.

    Median PFS and OS for bortezomib relapsed vs. refractory were as follows:

    Bortezomib Relapsed vs.
    Refractory Median PFS* Median OS**
    ----------------------- ----------- -----------

    Not Reached at 38+
    Bortezomib Relapsed (n=20) 8.8 months months
    -------------------------- ---------- ------------------
    95% CI (6.3, 11.2) 95% CI (25, NR)
    ------------------ ---------------

    Bortezomib Refractory (n=53) 5.7 months 22.5 months
    ---------- -----------
    95% CI (4.3, 6.4) 95% CI (12.3, NR)
    ---------------------------- ----------------- -----------------

    * Median PFS and median TTP were identical, as no patient deaths
    occurred prior to progression.
    ** Kaplan Meier methodology was used to determine overall survi
  8. [verwijderd] 3 februari 2010 17:37
    Key DevelopmentsKeryx Biopharmaceuticals Announces Special Protocol Assessment Agreement With FDA For Phase 3 Trial Of KRX
    8:30am EST
    Keryx Biopharmaceuticals announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, KRX-0401 (perifosine), in patients with refractory metastatic colorectal cancer. The SPA provides agreement that the Phase 3 study design adequately addresses objectives in support of a regulatory submission.
    AEterna Zentaris Inc. Partner Keryx Biopharmaceuticals Announces Positive Phase 2 Results For Perifosine As A Single Agent For Treatment Of Advanced Waldenstrom's Macroglobulinemia
    Friday, 29 Jan 2010 08:35am EST
    AEterna Zentaris Inc. announced that an article entitled Clinical and Translational Studies of a Phase II Trial of the Novel Oral Akt Inhibitor Perifosine in Relapsed or Relapsed/Refractory Waldenstrom's Macroglobulinemia, reporting Phase 2 data demonstrating the single agent activity of perifosine (KRX-0401) for the treatment of advanced Waldenstrom's Macroglobulinemia (Waldenstrom's), will appear in the February 1, 2010, issue of the Journal of Clinical Cancer Research. Perifosine, AEterna Zentaris's oral PI3K/Akt pathway inhibitor is currently being investigated in a Phase 3 trial, under Special Protocol Assessment, for the treatment of Multiple Myeloma. Like Multiple Myeloma and Non-Hodgkin's Lymphoma, Waldenstrom's is a hematologic disease in which the cancer cells target the bone marrow. Keryx Biopharmaceuticals is AEterna Zentaris' partner and licensee for perifosine in the United States, Canada and Mexico. Perifosine is also out-licensed to Handok in South Korea while AEterna Zentaris retains rights for the rest of the world. Dr. Irene Ghobrial, Assistant Professor of Medicine, Bing Center for Waldenstrom's Macroglobulinemia at Dana-Farber Cancer Institute, led the Phase 2 study in which 37 patients were treated with perifosine 150 mg daily for 6 cycles. In this study, 41% of the patients had 3 or more lines of prior therapy and 78% had 2 or more prior lines of therapy.
    Keryx Biopharmaceuticals Reports Benefit In Survival From Updated Results Of Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of KRX-0401
    Monday, 25 Jan 2010 08:30am EST
    Keryx Biopharmaceuticals announced that it has reported updated results on the clinical activity of KRX-0401 (perifosine), the Company's PI3K/Akt pathway inhibitor for cancer, in combination with capecitabine (Xeloda) as a treatment for advanced, metastatic colon cancer. In this randomized, double-blind, placebo controlled study conducted at 11 centers across the United States, heavily pre-treated patients with second- or third-line metastatic colon cancer were randomized to receive capecitabine (a chemotherapy used in advanced metastatic colon cancer which is marketed by Roche as Xeloda) at 825 mg/m2 BID (total daily dose of 1650 mg/m2) on days one - 14 every 21 days plus either perifosine or placebo at 50 mg daily. The study enrolled a total of 38 patients, 34 of which were third-line or greater. Of the 38 patients enrolled, 35 patients were evaluable for response (20 patients on the perifosine + capecitabine arm and 15 patients on the placebo + capecitabine arm). Three patients on the placebo + capecitabine arm were not evaluable for response (two patients were unevaluable due to toxicity (days 14, 46) and one was unevaluable due to a new malignancy on day six). All patients in the perifosine + capecitabine arm were evaluable for response. The patients in the study were heavily pre-treated, with the arms well-balanced in terms of prior treatment regimens. KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris Inc. in the United States, Canada and Mexico.
    Keryx Biopharmaceuticals Announces Special Protocol Assessment Agreement With FDA For Phase 3 Registration Program Of Zerenex In Treatment Of Hyperphosphatemia
    Tuesday, 5 Jan 2010 08:30am EST
    Keryx Biopharmaceuticals announced that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 clinical program for Zerenex(TM) (ferric citrate), its iron-based phosphate binder for the treatment of elevated serum phosphorous levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD). The SPA provides agreement that the Phase 3 program design adequately addresses objectives in support of a regulatory submission for drug approval. In accordance with the Company's SPA agreement with the FDA, the Phase 3 clinical program for Zerenex will consist of two clinical studies, as follows: Short-term efficacy study: A multicenter, randomized, open-label clinical trial with a planned enrollment of approximately 150 patients on hemodialysis, who will be randomized to fixed doses of Zerenex, ranging from one gram per day to eight grams per day, for a treatment period of 28 days. Patients will undergo a two week washout period prior to randomization. The primary endpoint of the study will be to demonstrate a dose response in the change of serum phosphorous from baseline (end of washout period) to end of the treatment period (day 28). This short-term study is expected to commence by the end of the first quarter of 2010, with data expected in the second half of 2010.
    Keryx Biopharmaceuticals Initiates Phase 3 Registration Trial of KRX-0401 (Perifosine) For Treatment Of Patients With Advanced Multiple Myeloma
    Wednesday, 16 Dec 2009 08:30am EST
    Keryx Biopharmaceuticals announced the initiation of a Phase 3 registration clinical trial for KRX-0401 (perifosine), the Company's PI3K/Akt pathway inhibitor, in relapsed or refractory multiple myeloma patients. The trial, entitled, a Phase 3 Randomized Study to Assess the Efficacy and Safety of Perifosine Added to the Combination of Bortezomib (Velcade) and Dexamethasone in Multiple Myeloma Patients Previously Treated with Bortezomib is a double-blind, placebo-controlled trial comparing the efficacy and safety of perifosine vs. placebo when combined with bortezomib (Velcade) and dexamethasone. The trial will enroll approximately 400 patients with relapsed or relapsed or refractory multiple myeloma. The primary endpoint is progression-free survival and secondary endpoints include overall response rate, overall survival and safety. This trial is being conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA). Additionally, the FDA has granted perifosine Orphan Drug and Fast Track designations in this indication. An estimated 40 to 50 centers throughout the United States and select centers outside of the United States will be participating in this Phase 3 trial.
    AEterna Zentaris Inc. Partner Keryx Biopharmaceuticals Reports Updated Phase 1/2 Data, Including New Survival Data On Perifosine (KRX-0401) In The Treatment Of Advanced Multiple Myeloma
    Monday, 7 Dec 2009 08:35am EST
    AEterna Zentaris Inc. announced that its partner Keryx Biopharmaceuticals reported updated efficacy and safety data as well as new survival data on the clinical activity of perifosine (KRX-0401) in combination with bortezomib (Velcade) (+/- dexamethasone) in patients with relapsed/refractory multiple myeloma. Data from the study entitled A Multicenter Phase 1/2 Study Evaluating the Safety and Efficacy of Peri
  9. [verwijderd] 8 april 2010 19:03
    Keryx Biopharmaceuticals and AEterna Zentaris Inc. announced the initiation of a Phase 3 registration clinical trial for KRX-0401 (perifosine), the Company's, potentially first in class, oral anti cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, for the treatment of patients with refractory advanced colorectal cancer. The Phase 3 trial, entitled the X-PECT (Xeloda + Perifosine Evaluation in Colorectal cancer Treatment) trial, is a randomized (1:1), double-blind trial comparing the efficacy and safety of perifosine, capecitabine vs. placebo, capecitabine in approximately 430 patients with refractory advanced colorectal cancer. Patients must have failed available therapy including 5 fluorouracil (5-FU), oxaliplatin (Eloxatin), irinotecan (Camptosar), bevacizumab (Avastin) and, if KRAS wild-type, failed therapy with prior cetuximab (Erbitux) or panitumumab (Vectibix). For oxaliplatin-based therapy, failure of therapy will also include patients who discontinued due to toxicity. The primary endpoint for this study is overall survival, with secondary endpoints including overall response rate, progression-free survival and safety. This trial is being conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration. Perifosine has also been granted Fast Track designation for the treatment of refractory advanced colorectal cancer.

  10. [verwijderd] 8 april 2010 19:40
    quote:

    David7492 schreef:

    [quote=genkie69]
    Ik heb er 2000 aan 0,20 dollar, ze waren bedoeld voor de lange termijn maar ga ze deze week toch ergens verkopen denk ik.
    [/quote]
    Niet verkopen.
    Bedankt voor je goede tip, sta op 1645% winst en met 2 fast tracks, 3 spa(special protocol assessment) en 1 orphan drug status ziet het er beter en beter uit.
  13. [verwijderd] 3 mei 2010 17:17
    quote:

    genkie69 schreef:

    [quote=David7492]
    [quote=genkie69]
    Ik heb er 2000 aan 0,20 dollar, ze waren bedoeld voor de lange termijn maar ga ze deze week toch ergens verkopen denk ik.
    [/quote]
    Niet verkopen.
    [/quote]

    Bedankt voor je goede tip, sta op 1645% winst en met 2 fast tracks, 3 spa(special protocol assessment) en 1 orphan drug status ziet het er beter en beter uit.
    Momenteel +2850% , het begint te kriebelen om te verkopen maar moest dit over een jaar de nieuwe DNDN worden dan sla ik mezelf de kop in denk ik.
  14. [verwijderd] 3 mei 2010 22:56
    Hoi genkie69,

    JAREN geleden had ik KERX gekocht boven de $ 14,=
    Hierna de dip in de koers meegemaakt toen een trial misliep. Hierna blijven zitten ook toen ze tot rond de $0,10 terugliepen omdat ik geloof in dit bedrijf.
    Op $0.22 heb ik bijgekocht waardoor ik nu op een totaal aantal aandelen KERX zit van 10.990.

    Ik ben geen enkel moment in de verleiding gekomen om ze te verkopen. Ben ook niet van plan dit te gaan doen op korte termijn, omdat ik in dit bedrijf geloof en omdat zij een aantal medicijnen in trial hebben die de potentie hebben om een veel betere behandeling van kankerpatienten te bewerkstelligen. Het is dus niet alleen een geldelijk gewin, maar ook van maatschappelijk belang. Gezien de hoeveelheid trials en de tussentijdse resultaten, zijn de kansen op succes zowel geldelijk alsook maatschappelijk aanzienlijk.

    Ook als de koers onder druk komt te staan mogen ze op mijn support rekenen zolang ze medicijnen proberen te maken tegen dit soort ziektes.

    Alibert
  15. [verwijderd] 4 mei 2010 17:46
    quote:

    Alibert schreef:

    Hoi genkie69,

    JAREN geleden had ik KERX gekocht boven de $ 14,=
    Hierna de dip in de koers meegemaakt toen een trial misliep. Hierna blijven zitten ook toen ze tot rond de $0,10 terugliepen omdat ik geloof in dit bedrijf.
    Op $0.22 heb ik bijgekocht waardoor ik nu op een totaal aantal aandelen KERX zit van 10.990.

    Ik ben geen enkel moment in de verleiding gekomen om ze te verkopen. Ben ook niet van plan dit te gaan doen op korte termijn, omdat ik in dit bedrijf geloof en omdat zij een aantal medicijnen in trial hebben die de potentie hebben om een veel betere behandeling van kankerpatienten te bewerkstelligen. Het is dus niet alleen een geldelijk gewin, maar ook van maatschappelijk belang. Gezien de hoeveelheid trials en de tussentijdse resultaten, zijn de kansen op succes zowel geldelijk alsook maatschappelijk aanzienlijk.

    Ook als de koers onder druk komt te staan mogen ze op mijn support rekenen zolang ze medicijnen proberen te maken tegen dit soort ziektes.

    Alibert
    Knap van je, petje af.
    Het moet trouwens wel een sterk bedrijf zijn als je in een offday voor de markt toch op +4% staat zonder nieuws (en dit na een stijging van 50% op 4 dagen).
  16. [verwijderd] 4 mei 2010 17:48
    quote:

    genkie69 schreef:

    [quote=Alibert]
    Hoi genkie69,

    JAREN geleden had ik KERX gekocht boven de $ 14,=
    Hierna de dip in de koers meegemaakt toen een trial misliep. Hierna blijven zitten ook toen ze tot rond de $0,10 terugliepen omdat ik geloof in dit bedrijf.
    Op $0.22 heb ik bijgekocht waardoor ik nu op een totaal aantal aandelen KERX zit van 10.990.

    Ik ben geen enkel moment in de verleiding gekomen om ze te verkopen. Ben ook niet van plan dit te gaan doen op korte termijn, omdat ik in dit bedrijf geloof en omdat zij een aantal medicijnen in trial hebben die de potentie hebben om een veel betere behandeling van kankerpatienten te bewerkstelligen. Het is dus niet alleen een geldelijk gewin, maar ook van maatschappelijk belang. Gezien de hoeveelheid trials en de tussentijdse resultaten, zijn de kansen op succes zowel geldelijk alsook maatschappelijk aanzienlijk.

    Ook als de koers onder druk komt te staan mogen ze op mijn support rekenen zolang ze medicijnen proberen te maken tegen dit soort ziektes.

    Alibert
    [/quote]

    Knap van je, petje af.
    Het moet trouwens wel een sterk bedrijf zijn als je in een offday voor de markt toch op +4% staat zonder nieuws (en dit na een stijging van 50% op 4 dagen).
    Nooit mensen op een forum geloven, ik kan ook alles zomaar neerpennen hier.
  17. [verwijderd] 5 mei 2010 08:12
    Beste klep 1,

    Je hoeft me niet te geloven. Niemand hoeft me te geloven. Ikzelf weet dat het waar is wat er staat en daar gaat het om. Ik zal dan ook geen pogingen doen om te bewijzen dat het ook zo is. Doet er ook niet toe of je me wel of niet gelooft. Het staat ook niet geschreven ter meerdere glorie van mijzelf. Alleen jammer dat je zo weinig vertrouwen in medemensen hebt. Soms is het goed om voorzichtig te zijn, maar om maar per definitie aan te nemen dat het toch onzin is wat er geschreven wordt?

    Ik wilde alleen maar aangeven dat ik in dit bedrijf geloof en hoop dat zij een verandering ten goede kunnen bewerkstelligen.

    Alibert
  18. [verwijderd] 2 mei 2011 09:37
    Keryx Biopharmaceuticals (Nasdaq: KERX) today announced the final dataset from the Phase 3 short-term clinical trial of Zerenex™ (ferric citrate) for the treatment of hyperphosphatemia in end-stage renal disease patients on dialysis. The Zerenex data was presented earlier today at the National Kidney Foundation Spring Clinical Meetings being held in Las Vegas, Nevada, in an oral presentation by David S. Goldfarb, M.D., Clinical Chief of Nephrology, NYU Langone Medical Center, Professor of Medicine & Physiology, NYU School of Medicine. On November 30, 2010, the Company issued a press release announcing positive top-line results from this Phase 3 short-term study.
    Phase 3 short-term study design

    This Phase 3 study was a multicenter, randomized, open-label trial with a two-week washout period, following which patients were randomized 1:1:1 to receive a fixed dose of Zerenex of either 1 gram, 6 grams or 8 grams per day for a treatment period of 28 days. Zerenex was administered using a 1 gram oral caplet formulation, hence, the fixed-dose arms of 1 gram, 6 grams and 8 grams per day represent 1, 6 and 8 pills per day, respectively.

    One hundred fifty-one dialysis patients were enrolled into the study. The Intent-to-Treat (ITT) group included 146 patients, representing all patients who took at least one dose of Zerenex and provided a Baseline (at the end of washout) and at least one post-Baseline efficacy assessment. Efficacy assessments were taken weekly starting at Baseline and subsequently at days 7, 14, 21 and 28.

    EFFICACY DATA ANALYSES

    The primary endpoint of the study was to determine whether there was a dose response in the change in serum phosphorus from Baseline to Day 28 in the ITT group, using a regression analysis to evaluate this objective.

    The study met the primary endpoint, with the regression analysis indicating a highly statistically significant dose response (p<0.0001).

    Additional efficacy results are as follows:

    Mean Serum Phosphorus (mg/dL)
    ITT (n=146)
    1g/Day
    (n=50)
    6g/Day
    (n=51)
    8g/Day
    (n=45)

    Baseline (End of Washout)
    7.3
    7.6
    7.5

    Day 28/LOCF* (End of Treatment)
    7.4
    5.6
    5.3

    Change from Baseline at Day 28
    P-Value
    0.1

    -2.0
    <0.0001
    -2.2
    <0.0001

    % Change from Baseline at Day 28
    0.5%
    -25.7%
    -29.6%

    * Last observation carried forward was used for missing data.

    Additional highlights from Dr. Goldfarb's presentation on Zerenex are as follows:

    Statistically significant dose response increase in serum bicarbonate suggests potential to address metabolic acidosis
    Statistically significant dose response reduction in calcium x phosphorus product
    Modest upward trends in Ferritin and TSAT in 6 grams/day and 8 grams/day dose groups further supports theory that Zerenex could reduce the need for intravenous iron and erythropoiesis-stimulating agent (ESA) use
    Zerenex appeared to be safe and well-tolerated in the study
    GI adverse events were mostly mild and transient in nature
    No SAEs were deemed to be drug-related by the Data Safety Monitoring Committee

    Dr. Goldfarb concluded that Zerenex has the potential to become a viable alternative to the currently approved phosphate binders used to treat ESRD patients.

    Ron Bentsur, Chief Executive Officer of Keryx, stated, "We are encouraged by the final efficacy and safety data from the Phase 3 short term study presented earlier today, which confirm the top-line data previously reported." Mr. Bentsur continued, "We thank Dr. Goldfarb for his time and effort in preparing for and delivering this morning's presentation."

    In accordance with the Company's Special Protocol Assessment (SPA) agreement with the FDA, the Phase 3 clinical program for Zerenex consists of two clinical studies, the completed short-term study, and a long-term safety and efficacy study that is currently ongoing.
  19. [verwijderd] 28 januari 2013 17:57
    Keryx Biopharmaceuticals Announces Zerenex™ (ferric citrate) Meets Primary and All Key Secondary Endpoints in Phase 3 Long-Term Study as a Treatment for Hyperphosphatemia in End-Stage Renal Disease Patients on Dialysis
    Zerenex Significantly Increases Iron Storage Parameters and Decreases Need for Intravenous Iron and Erythropoiesis-Stimulating Agents Versus Active Control
    U.S. and European New Drug Application Submissions Anticipated in Second Quarter 2013
    Conference Call to Be Held Today, Monday, January 28, 2013, at 8:00 am Eastern Time
    NEW YORK, Jan. 28, 2013 /PRNewswire/ -- Keryx Biopharmaceuticals, Inc. (NASDAQ: KERX) today announced successful top-line results from the long-term Phase 3 study of Zerenex™ (ferric citrate), the Company's ferric iron-based phosphate binder drug candidate, for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with end-stage renal disease (ESRD) on dialysis. In this study, Zerenex met the study's primary endpoint, described below, demonstrating a highly statistically significant change in serum phosphorus versus placebo over the four-week Efficacy Assessment Period of the study. In addition, Zerenex met the key secondary endpoints of increasing ferritin and transferrin saturation (TSAT) and reducing the use of intravenous (IV) iron and erythropoiesis-stimulating agents (ESAs) versus the active control over the 52-week Safety Assessment Period of the study. This long-term study was the final component of the Company's Phase 3 registration program, which was conducted pursuant to a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA). In April 2011, the Company reported the positive final dataset from the short-term study component of this Phase 3 registration program. The Company expects to submit a New Drug Application (NDA) with the FDA and a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) for Zerenex in the second quarter of 2013.
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