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Home  /  Forum  /  uniQure  /  Wat is de waarde van uniQure?

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uniQure« Terug naar discussie overzicht

Wat is de waarde van uniQure?

7.806 Posts
Pagina: «« 1 ... 259 260 261 262 263 ... 391 »» | Laatste | Omlaag ↓
  2. forum rang 10 DeZwarteRidder 3 december 2016 18:07
    quote:

    ch@rter schreef op 3 december 2016 17:42:

    What the hell heeft cytodyn (otc rommel) met qure te maken riddert ....
    Allebei biotech en een van beide heeft een grote kans op een goedkeuring van een geneesmiddel in 2017.

    ---------------------------------------------------------

    02 december 2016 05:36
    Charlie Sheen gebruikt nieuw middel tegen HIV

    Charlie Sheen gebruikt een nieuw medicijn tegen HIV. Dat meldt het Britse dagblad The Daily Mail.

    Charlie sprak donderdag met de krant vanwege Wereld AIDS Dag. De acteur liet vorig jaar weten besmet te zijn met HIV en antiretrovirale medicijnen te slikken. Dat zijn vaak een of twee tabletten die dagelijks moeten worden ingenomen om het HIV virus te onderdrukken.

    Sinds januari maakt de acteur deel uit van een groep patiënten die experimenteert met een wekelijkse injectie, in plaats van het dagelijks slikken van de tabletten. "Het is onmogelijk geweldig", aldus een enthousiaste Charlie. "Persoonlijk: ik denk terug hoe ik me voelde toen ik hiermee begon en hoe ik me nu voel. Wow. Over een transformatie gesproken", vervolgt de 51-jarige acteur.

    De wekelijkse injectie is met het middel PRO-140, dat iets anders werkt dan de antiretrovirale pillen. Ook het feit dat het medicijn maar eenmaal per week hoeft te worden toegediend is hoopgevend, met name voor patiënten die in afgelegen gebieden wonen of meerdere gezondheidsklachten hebben. Als het experiment slaagt kan het medicijn eind 2017 of begin 2018 op de markt verschijnen.
    ANP

    2

  4. Prof. Dollar 3 december 2016 22:18
    uniQure Announces First Clinical Data From Second Dose Cohort of AMT-060 in Ongoing Phase I/II trial in Patients with Severe Hemophilia B

    -- Second-dose Cohort Demonstrates Dose Response with All Patients Free of Prophylactic FIX Replacement Therapy and Only One Spontaneous Bleed Reported

    -- Low-Dose Cohort Shows Sustained Levels of FIX Activity Up To One Year, with Marked Reduction of Bleeding Over Time and a Complete Cessation of Spontaneous Bleedings in Last 14 Weeks of Observation

    --No Activation of T-Cell Responses or Loss of FIX Activity in Any Patients

    --Investor Webcast Monday, December 5, 2016 at 7:00 a.m. PST/10 a.m. EST

    Volledig bericht:
    www.uniqure.com/investors-newsroom/pr...
  8. [verwijderd] 4 december 2016 11:49
    quote:

    Prof. Dollar schreef op 3 december 2016 22:18:

    uniQure Announces First Clinical Data From Second Dose Cohort of AMT-060 in Ongoing Phase I/II trial in Patients with Severe Hemophilia B

    -- Second-dose Cohort Demonstrates Dose Response with All Patients Free of Prophylactic FIX Replacement Therapy and Only One Spontaneous Bleed Reported

    -- Low-Dose Cohort Shows Sustained Levels of FIX Activity Up To One Year, with Marked Reduction of Bleeding Over Time and a Complete Cessation of Spontaneous Bleedings in Last 14 Weeks of Observation

    --No Activation of T-Cell Responses or Loss of FIX Activity in Any Patients

    --Investor Webcast Monday, December 5, 2016 at 7:00 a.m. PST/10 a.m. EST

    Volledig bericht:
    www.uniqure.com/investors-newsroom/pr...
    Dank prof.D
    Dat is nog eens leuk wakker worden.
    Outcome in zn geheel gelezen en oogt zeer stabiel en positief, ondanks dat het voor mij een soort van abacadabra-taal is lees ik objectief een solide voortgang van zaken.

    Graag lees ik ook jouw persoonlijke mening hierover aangezien jij hier veeel meer kaas van gegeten hebt en studies al vele jaren op de voet volgt.

    Gr
  10. flosz 4 december 2016 12:59
    quote:

    flosz schreef op 4 december 2016 02:56:

    Mooi!
    Goal of gene therapy in Hemophilia B: shift patients from severe to mild disease.

    High-dose cohort, 5 pat.having severe<1 #hemophilaB : 4 pat.mild phenotype, 1 pat.moderate phenotype post 22-26 wks AMT-060
    twitter.com/floszcrxl/status/80537220...

    ///////////

    Hemophilia phenotype:

    uniQure
    Nine patients in the trial were classified as having severe (<1% FIX activity) hemophilia. One patient in the low-dose cohort had a moderate/severe (1.5% FIX).
    twitter.com/floszcrxl/status/80522132...

    Spark
    Patients moderate ( >2% FIX activity and no underlying HBV or HCV). Patients 4/8/9: no bleeds one year prior to treatment. Patient 4 had no infusions (either on-demand or prophylaxis).
    twitter.com/floszcrxl/status/80517715...

    ////////

    uniQure

    Leebeek: "Importantly, at both doses evaluated, AMT-060 appears to be safe and well-tolerated with no loss of FIX activity, no activation of T-cell response and no development of inhibitors for any of the 10 patients in the study. 
    "In total, we are observing a therapeutic benefit from AMT-060 that is clearly superior to their  previous prophylactic FIX  replacement therapy regimen, even in patients with advanced joint disease who still experienced many bleeds despite prophylaxis with FIX," he added.  "The safety and clinical efficacy profile observed in this study, together with the higher FIX expression levels support selection of the 2x1013 gc/kg dose for a pivotal registration trial."   

    * Three out of the total of 10 patients (two in the second-dose cohort and one previously reported from the low-dose cohort) experienced mild, asymptomatic elevations of alanine aminotransferase (ALT) and received a tapering course of corticosteroids per protocol. Importantly, the temporary elevations in ALT were not associated with any loss of endogenous FIX activity or T-cell response.

    Spark

    Two of the nine participants experienced asymptomatic, transient elevation in liver enzymes associated with an immune response to the Spark100 vector capsid during the first four to eight weeks following administration. In one participant, this response was accompanied by a decline in factor IX activity level from 32 to 12 percent, as of Nov. 30, 2016

    Eight of the infused participants have required no factor IX concentrates to prevent or control bleeding events since the day after vector administration. One participant with severe joint disease self-administrated a precautionary infusion two days after administration of SPK-9001 for a suspected ankle bleed and again at week 35, post the data cut-off date and despite a factor IX activity level of 36 percent, for a suspected knee bleed.
    ir.sparktx.com/phoenix.zhtml?c=253900...
  15. forum rang 10 DeZwarteRidder 5 december 2016 12:42
    CSL Behring Presents New Phase III Analysis of IDELVION® for Hemophilia B at the 2016 American Society of Hematology Annual Meeting
    V.CSL, CSLLY | 1 day ago
    - Analysis of clinical trial efficacy results and estimated factor IX levels suggests that patients who maintain factor IX activity levels above 5 and 10 percent have significantly reduced bleeding risk
    - IDELVION is the first and only factor IX therapy with up to 14-day dosing for routine prophylaxis in appropriate hemophilia B patients

    PR Newswire

    SAN DIEGO, Dec. 3, 2016 /PRNewswire/ -- Global biotherapeutics leader CSL Behring today announced new results from its Phase III clinical development program evaluating IDELVION® [Coagulation Factor IX (Recombinant), Albumin Fusion Protein], the company's novel, long-acting recombinant albumin fusion protein for the treatment of hemophilia B. The results, from a pooled analysis of clinical studies from the global PROLONG-9FP program, assessed the relationship between estimated factor IX activity levels and clinical bleeding risk in adult hemophilia B patients treated with IDELVION using prophylaxis or on-demand (episodic) treatment. Analysis of factor IX activity versus efficacy showed that adult patients achieving sustained factor IX activity levels above 5 or 10 percent, have approximately 80 percent lower risk of bleeding events over one year compared with patients having factor IX activity levels below these thresholds. The findings were presented at the 58th annual meeting of the American Society of Hematology (ASH) in San Diego, December 3-6.

    "This new analysis of Phase III IDELVION clinical trials shows a strong association between high and prolonged factor IX levels and efficacy of IDELVION in reducing bleeding risk in adult hemophilia B patients," said John Roberts, Ph.D., Director of Clinical Pharmacology, CSL Behring, and lead investigator. "These findings provide additional clinical rationale for targeting and maintaining factor IX trough activity levels above 5 or 10 percent to optimize treatment outcomes, aligning with World Federation of Hemophilia clinical guidelines for the management of hemophilia."

    In March 2016, IDELVION was approved in the U.S. The long-acting therapy is also approved in the European Union, Japan, Australia, Switzerland and Canada. In the U.S., IDELVION is indicated for use in children and adults with hemophilia B for routine prophylaxis to prevent or reduce the frequency of bleeding episodes, on-demand control and prevention of bleeding episodes and the perioperative management of bleeding (around the time of surgery). Regulatory approvals of IDELVION were based on results from the global PROLONG-9FP clinical development program, which included five Phase I through Phase III open-label, multicenter studies evaluating the pharmacokinetics (PK), safety and efficacy of IDELVION in children and adults with hemophilia B.

    "CSL Behring's research presentation at ASH 2016 demonstrates our commitment to advance coagulation science and optimize treatment outcomes for people living with hemophilia B," said Jerry Powell, M.D., Medical Director, North America Commercial Operations, CSL Behring. "IDELVION is the only available recombinant factor IX therapy that maintains high factor levels using 14-day dosing intervals, helping to provide excellent bleeding control for hemophilia B patients. Furthermore, IDELVION has been shown to maintain high steady-state factor IX levels (21 percent at 7 days and 13 percent at 14 days, on 7- and 14-day dosing regimens, respectively)."

    Key Study Findings
    Bleeding risk reduction in relation to predicted factor IX levels in hemophilia B patients receiving IDELVION (abstract #1411): This abstract reported on a pharmacostatistical analysis utilizing pooled PK and efficacy data from the pivotal Phase III trials from PROLONG-9FP. A total of 478 bleeding episodes in 57 adult patients with hemophilia B (factor IX levels =2 percent) were evaluated. Investigators estimated factor IX activity levels utilizing available PK data and population PK methods for patients receiving IDELVION prophylaxis treatment (7-day, 10-day and 14-day regimens) and on-demand treatment. The majority of bleeding episodes occurred during the on-demand phase of the studies.

    The results suggest a statistically significant relationship between factor IX exposure and bleeding risk, as measured by the time from the start of treatment to the first major bleeding event. Patients taking IDELVION for one year who maintained cumulative factor IX trough levels above 5 percent and above 10 percent were predicted to significantly reduce their bleeding risk by greater than 80 percent, compared with patients having lower trough levels of factor IX activity. Sustained cumulative factor IX activity above 2 percent did not provide significant risk reduction over one year. Patients with daily factor IX trough levels above 5 percent and 10 percent were also predicted to reduce their everyday bleeding risk by greater than 77 percent on average.

    Read more at www.stockhouse.com/news/press-release...
  16. forum rang 10 DeZwarteRidder 5 december 2016 12:47
    Billion-Dollar ‘Biobuck’ Deals Are Mostly Hype
    By Shobhit Seth | November 28, 2016 — 4:42 AM EST

    Pharmaceutical major Novartis AG (NVS) inked a $2.6 billion deal in June with Xencor Inc. (XNCR) for blood cancer drugs. While Xencor received $150 million upfront, the remaining $2.41 billion in payments were conditional, as they were tied to clinical, regulatory, and sales milestones. (For more, see Novartis Unveils Heart Failure Social Network.)

    In April 2016, Allergan PLC (AGN) signed a $3.3 billion licensing deal for neurological disorder drugs with Heptares with a $125 million upfront payment. The rest was slated as $665 million in milestones for clinical development, and up to $2.5 billion in conditional payments were sales milestones.

    Bristol-Myers Squibb Co. (BMY) made a similar big bet – worth $1 billion – on UniQure (QURE) in April 2015, but only $50 million was paid upfront, with the rest being tied to the achievement of multiple milestones. Things aren’t looking great despite the huge deal, as UniQure is undergoing massive restructuring. (For more, see UniQure Cuts Jobs, Consolidates Pipeline.)
7.806 Posts
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