Pharma e Biotech - Europa NicOx : Quelli che aspettano ,,,, ridendo !!! (10 lettori)
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Prezzemolo
numero magico 000074130
è ora di comprarnealtre mille almeno ...
pensa come va giù il PMC .
Miki.
questo consiglio lo ho attuato la scorsa settimana; un altro bi-migliaio perchè a questi prezzi ( chiaramente avendo ancora la fiducia nella societa' ) è una occasione d'oro.
se mi sono sbagliato è' stata solo una mia responsabile decisione.
un saluto a tutti.
Miki53
Nessun pasto è gratis
bè ...mica parlo a vanvera ....
accchhhh ....1000 cox costavano (quando le presi 2650 Euro )
Pochi mesi fa ce ne andavano più di 8000.
piuttosto vado meno in vacanza ....
Però , anche se non tutto è proprio chiaro , mi tagliano troppo il prezzo .
Ok l'ho detta e non vuole essere un invito a nessuno .
Vediamo il bicchiere mezzo pieno ... di Calvà .
Saluti.
miki.
accchhhh ....1000 cox costavano (quando le presi 2650 Euro )
Pochi mesi fa ce ne andavano più di 8000.
piuttosto vado meno in vacanza ....
Però , anche se non tutto è proprio chiaro , mi tagliano troppo il prezzo .
Ok l'ho detta e non vuole essere un invito a nessuno .
Vediamo il bicchiere mezzo pieno ... di Calvà .
Saluti.
miki.
magolibero
..se la sà gira..
come si traduce / interpreta la parte quotata ?
é corretto così come di seguito ?
- un partner per NCX-6560 interessato a entrare a questo punto della sperimentazione (prima di inizio fase II) c'é già..
- ..e anche se per NicOx la cosa migliore sarebbe che ciò avvenisse afase II conclusa
- ..qualora con Naproxcinod ci fossero ulteriori slittamenti/problemi ..dando corso a punto !) non ci sarebbero problemi per "stabilità finanziaria"
ugotega
Forumer storico
doctor NO
NO nel DNA
1er ABSTRACT à l'EULAR
Auj. à 07:15
FRI0464 13-WEEK EFFICACY AND SAFETY EVALUATION OF NAPROXCINOD, A FIRST-IN-CLASS CYCLOOXYGENASE INHIBITING NITRIC OXIDE DONATOR (CINOD), IN PATIENTS WITH OSTEOARTHRITIS OF THE HIP
C. G. Baerwald 1,*, H. Frayssinet 2, T. Ferreira 2, B. Duquesroix 2, T. Schnitzer 3
1Klinik fur Gastroenterologie und Rheumatologie, Universitatskinlinikum Leipzig, Leipzig, Germany, 2NicOx, SA, Sophia Antipolis, France, 3Northwestern University, Chicago, United States
Background: Naproxcinod is a first-in-class Cyclooxygenase Inhibiting Nitric Oxide Donator (CINOD) under development for the relief of signs and symptoms of osteoarthritis (OA). Naproxcinod has demonstrated anti-inflammatory and analgesic properties similar to traditional NSAIDs and COX-2 inhibitors. It has shown a good safety profile in previous trials in knee OA so it was evaluated in this study in OA of the hip.
Objectives: The primary objective of this study was to demonstrate that naproxcinod 750 mg bid was superior to placebo bid in relieving OA signs and symptoms in patients with OA of the hip. The secondary objectives were to evaluate the effect on blood pressure (BP) of naproxcinod 750 mg bid, vs. placebo bid and naproxen 500 mg bid, as measured by Office Blood Pressure Monitoring (OBPM); and to evaluate the general safety and tolerability of naproxcinod 750 mg bid vs. placebo bid and naproxen 500 mg bid.
Methods: 810 patients with primary hip OA experiencing pain flare at baseline after discontinuation of previous analgesic treatment were randomized at 105 European and North American centers to naproxcinod 750mg, placebo or naproxen 500mg (all bid) in a 2:2:1 ratio. Efficacy was assessed using 3 co-primary endpoints: change from baseline in WOMAC™ pain and function subscales, and patients’ overall rating of disease status at Week 13. Several secondary efficacy assessments were also performed. The primary efficacy variables were analyzed using an ANCOVA model with treatment group and site as factors, and the appropriate baseline value as a covariate. Safety was assessed by adverse events (AEs), standardized BP monitoring, ECGs, laboratory assessments, and physical examinations.
Results: 810 patients were randomized (ITT population): 65.6% female, 97% Caucasian, mean age 63 years. 50.5% of patients were hypertensive, 13.6% were diabetic and 19.5% used low dose aspirin. Overall, 23.6% of patients discontinued from the study prematurely, primarily due to lack of efficacy (7.8%), with most patients being in the placebo group. Naproxcinod 750mg demonstrated statistically significant superiority over placebo for all 3 co-primary efficacy variables at all time points (p<0.0001). Results seen in the naproxen group were similar to those in the naproxcinod group. Treatments were well tolerated. At least one AE was reported in 43.2% patients in the naproxcinod 750mg group, 38.2% in the placebo group and 46.8% in the naproxen 500mg group. Most AEs were mild or moderate in severity, and the incidence of SAEs was low and similar among treatment groups (1.5% to 2.6%). The BP profile was similar in the naproxcinod and placebo groups, while patients on naproxen showed a BP increase relative to placebo.
Conclusion: Naproxcinod was statistically superior to placebo during 13 weeks of treatment in relieving the signs and symptoms of OA of the hip, as evidenced by all 3 co-primary efficacy variables. These results reflect those seen in other Phase 3 studies and demonstrate a clinical benefit following naproxcinod treatment in the more difficult indication of OA of the hip. Naproxcinod was well tolerated with a BP profile similar to placebo, while naproxen increased BP compared to placebo.
Disclosure of Interest: C. Baerwald: None Declared, H. Frayssinet Employee of: NicOx SA, Sophia Antipolis, France, T. Ferreira Employee of: NicOx SA, Sophia Antipolis, France, B. Duquesroix Employee of: NicOx SA, Sophia Antipolis, France, T. Schnitzer Shareholder of: NicOx SA, Sophia Antipolis, France, Consultant for: NicOx SA, Sophia Antipolis, France
Auj. à 07:15
FRI0464 13-WEEK EFFICACY AND SAFETY EVALUATION OF NAPROXCINOD, A FIRST-IN-CLASS CYCLOOXYGENASE INHIBITING NITRIC OXIDE DONATOR (CINOD), IN PATIENTS WITH OSTEOARTHRITIS OF THE HIP
C. G. Baerwald 1,*, H. Frayssinet 2, T. Ferreira 2, B. Duquesroix 2, T. Schnitzer 3
1Klinik fur Gastroenterologie und Rheumatologie, Universitatskinlinikum Leipzig, Leipzig, Germany, 2NicOx, SA, Sophia Antipolis, France, 3Northwestern University, Chicago, United States
Background: Naproxcinod is a first-in-class Cyclooxygenase Inhibiting Nitric Oxide Donator (CINOD) under development for the relief of signs and symptoms of osteoarthritis (OA). Naproxcinod has demonstrated anti-inflammatory and analgesic properties similar to traditional NSAIDs and COX-2 inhibitors. It has shown a good safety profile in previous trials in knee OA so it was evaluated in this study in OA of the hip.
Objectives: The primary objective of this study was to demonstrate that naproxcinod 750 mg bid was superior to placebo bid in relieving OA signs and symptoms in patients with OA of the hip. The secondary objectives were to evaluate the effect on blood pressure (BP) of naproxcinod 750 mg bid, vs. placebo bid and naproxen 500 mg bid, as measured by Office Blood Pressure Monitoring (OBPM); and to evaluate the general safety and tolerability of naproxcinod 750 mg bid vs. placebo bid and naproxen 500 mg bid.
Methods: 810 patients with primary hip OA experiencing pain flare at baseline after discontinuation of previous analgesic treatment were randomized at 105 European and North American centers to naproxcinod 750mg, placebo or naproxen 500mg (all bid) in a 2:2:1 ratio. Efficacy was assessed using 3 co-primary endpoints: change from baseline in WOMAC™ pain and function subscales, and patients’ overall rating of disease status at Week 13. Several secondary efficacy assessments were also performed. The primary efficacy variables were analyzed using an ANCOVA model with treatment group and site as factors, and the appropriate baseline value as a covariate. Safety was assessed by adverse events (AEs), standardized BP monitoring, ECGs, laboratory assessments, and physical examinations.
Results: 810 patients were randomized (ITT population): 65.6% female, 97% Caucasian, mean age 63 years. 50.5% of patients were hypertensive, 13.6% were diabetic and 19.5% used low dose aspirin. Overall, 23.6% of patients discontinued from the study prematurely, primarily due to lack of efficacy (7.8%), with most patients being in the placebo group. Naproxcinod 750mg demonstrated statistically significant superiority over placebo for all 3 co-primary efficacy variables at all time points (p<0.0001). Results seen in the naproxen group were similar to those in the naproxcinod group. Treatments were well tolerated. At least one AE was reported in 43.2% patients in the naproxcinod 750mg group, 38.2% in the placebo group and 46.8% in the naproxen 500mg group. Most AEs were mild or moderate in severity, and the incidence of SAEs was low and similar among treatment groups (1.5% to 2.6%). The BP profile was similar in the naproxcinod and placebo groups, while patients on naproxen showed a BP increase relative to placebo.
Conclusion: Naproxcinod was statistically superior to placebo during 13 weeks of treatment in relieving the signs and symptoms of OA of the hip, as evidenced by all 3 co-primary efficacy variables. These results reflect those seen in other Phase 3 studies and demonstrate a clinical benefit following naproxcinod treatment in the more difficult indication of OA of the hip. Naproxcinod was well tolerated with a BP profile similar to placebo, while naproxen increased BP compared to placebo.
Disclosure of Interest: C. Baerwald: None Declared, H. Frayssinet Employee of: NicOx SA, Sophia Antipolis, France, T. Ferreira Employee of: NicOx SA, Sophia Antipolis, France, B. Duquesroix Employee of: NicOx SA, Sophia Antipolis, France, T. Schnitzer Shareholder of: NicOx SA, Sophia Antipolis, France, Consultant for: NicOx SA, Sophia Antipolis, France
doctor NO
NO nel DNA
2ème ABSTRACT
Auj. à 07:16
THU0382 ONSET OF GASTROINTESTINAL ADVERSE EVENTS OF NAPROXCINOD VS. NAPROXEN AND PLACEBO IN PATIENTS WITH OSTEOARTHRITIS
B. L. Cryer 1,*, A. Lanas 2, R. Fleming 3, F. Dolfi 4, D. Aguirre 4, B. Duquesroix 4
1Gastroenterology, UT Southwestern Medical School, Dallas, United States, 2Gastroenterology, University of Zaragoza, Zaragoza, Spain, 3NicOx Inc, Warren, United States, 4NicOx SA, Sophia Antipolis, France
Background: NSAIDs are widely prescribed for the symptomatic treatment of osteoarthritis (OA) but their use is hampered by gastrointestinal (GI) and cardiovascular side effects. Naproxcinod is a first-in-class Cyclooxygenase-Inhibiting Nitric Oxide Donator (CINOD) exerting its effect by a dual mechanism of action by liberation of naproxen and a NO releasing moiety. Previous studies have shown naproxcinod to have similar efficacy to naproxen in OA patients. However, naproxcinod was less likely to increase blood pressure and showed a more favorable GI endoscopic profile.
Objectives: To evaluate the time to onset of GI adverse events (AEs) of naproxcinod 750 mg bid and naproxcinod 375 mg bid vs naproxen 500 mg bid and placebo bid in OA patients.
Methods: In this analysis the safety populations were pooled from three large randomized Phase 3 OA studies (13 weeks of treatment) including two dose regimens of naproxcinod, naproxen and placebo. GI AEs and discontinuations due to GI AEs were part of a pre-planned descriptive statistical analysis. A post-hoc analysis of time to onset of GI AEs and discontinuations due to GI AEs among the different treatment groups was performed by estimating the distributions of the times to onset using Kaplan-Meier methods and comparing the distributions among the treatment groups using log rank test.
Results: A total of 2741 patients were included in the analysis: 801 on naproxcinod 750 mg, 489 on naproxcinod 375 mg, 638 on naproxen 500 mg and 813 on placebo. Demography and baseline characteristics were well balanced among groups and reflected those of the general OA population. At least one GI AE was reported by 138 (17.2%) patients on naproxcinod 750 mg bid, 69 (14.1%) on naproxcinod 375 mg bid, 128 (20.1%) on naproxen and 109 (13.4%) on placebo. Few patients discontinued due to at least one GI AE: 27 (3.4%) on naproxcinod 750 mg bid, 9 (1.8%) on naproxcinod 375 mg bid, 29 (4.5%) on naproxen and 27 (3.3%) on placebo.
Time to onset of GI AEs for the different treatment groups is presented below.
Overall, the difference among the treatment groups was significant (log rank p-value=0.0050). Time to onset of discontinuations due to GI AEs showed a similar trend but the difference was not significant among treatment groups.
Image / Graph:
Conclusion: This analysis showed that over a period of 13 weeks of treatment, GI AEs occurred earlier in naproxen-treated patients. In addition, GI AEs were less likely to occur in naproxcinod-treated patients than in naproxen-treated patients. A similar trend was observed for discontinuations due to GI AEs.
References: HCT 3012-X-301, -302 up to 13 weeks of treatment, -303
Disclosure of Interest: B. Cryer Consultant for: NicOx, A. Lanas Consultant for: NicOx, R. Fleming Employee of: NicOx, F. Dolfi Employee of: NicOx, D. Aguirre Employee of: NicOx, B. Duquesroix Employee of: NicOx
beh stando ai due astratti non vedo motivi per non approvare il naproxcinod!!!!!!!!!!!!!!!!!!!!!!!!
Auj. à 07:16
THU0382 ONSET OF GASTROINTESTINAL ADVERSE EVENTS OF NAPROXCINOD VS. NAPROXEN AND PLACEBO IN PATIENTS WITH OSTEOARTHRITIS
B. L. Cryer 1,*, A. Lanas 2, R. Fleming 3, F. Dolfi 4, D. Aguirre 4, B. Duquesroix 4
1Gastroenterology, UT Southwestern Medical School, Dallas, United States, 2Gastroenterology, University of Zaragoza, Zaragoza, Spain, 3NicOx Inc, Warren, United States, 4NicOx SA, Sophia Antipolis, France
Background: NSAIDs are widely prescribed for the symptomatic treatment of osteoarthritis (OA) but their use is hampered by gastrointestinal (GI) and cardiovascular side effects. Naproxcinod is a first-in-class Cyclooxygenase-Inhibiting Nitric Oxide Donator (CINOD) exerting its effect by a dual mechanism of action by liberation of naproxen and a NO releasing moiety. Previous studies have shown naproxcinod to have similar efficacy to naproxen in OA patients. However, naproxcinod was less likely to increase blood pressure and showed a more favorable GI endoscopic profile.
Objectives: To evaluate the time to onset of GI adverse events (AEs) of naproxcinod 750 mg bid and naproxcinod 375 mg bid vs naproxen 500 mg bid and placebo bid in OA patients.
Methods: In this analysis the safety populations were pooled from three large randomized Phase 3 OA studies (13 weeks of treatment) including two dose regimens of naproxcinod, naproxen and placebo. GI AEs and discontinuations due to GI AEs were part of a pre-planned descriptive statistical analysis. A post-hoc analysis of time to onset of GI AEs and discontinuations due to GI AEs among the different treatment groups was performed by estimating the distributions of the times to onset using Kaplan-Meier methods and comparing the distributions among the treatment groups using log rank test.
Results: A total of 2741 patients were included in the analysis: 801 on naproxcinod 750 mg, 489 on naproxcinod 375 mg, 638 on naproxen 500 mg and 813 on placebo. Demography and baseline characteristics were well balanced among groups and reflected those of the general OA population. At least one GI AE was reported by 138 (17.2%) patients on naproxcinod 750 mg bid, 69 (14.1%) on naproxcinod 375 mg bid, 128 (20.1%) on naproxen and 109 (13.4%) on placebo. Few patients discontinued due to at least one GI AE: 27 (3.4%) on naproxcinod 750 mg bid, 9 (1.8%) on naproxcinod 375 mg bid, 29 (4.5%) on naproxen and 27 (3.3%) on placebo.
Time to onset of GI AEs for the different treatment groups is presented below.
Overall, the difference among the treatment groups was significant (log rank p-value=0.0050). Time to onset of discontinuations due to GI AEs showed a similar trend but the difference was not significant among treatment groups.
Image / Graph:
Conclusion: This analysis showed that over a period of 13 weeks of treatment, GI AEs occurred earlier in naproxen-treated patients. In addition, GI AEs were less likely to occur in naproxcinod-treated patients than in naproxen-treated patients. A similar trend was observed for discontinuations due to GI AEs.
References: HCT 3012-X-301, -302 up to 13 weeks of treatment, -303
Disclosure of Interest: B. Cryer Consultant for: NicOx, A. Lanas Consultant for: NicOx, R. Fleming Employee of: NicOx, F. Dolfi Employee of: NicOx, D. Aguirre Employee of: NicOx, B. Duquesroix Employee of: NicOx
beh stando ai due astratti non vedo motivi per non approvare il naproxcinod!!!!!!!!!!!!!!!!!!!!!!!!
doctor NO
NO nel DNA
Conclusion: Le naproxcinod a été statistiquement supérieur au placebo pendant 13 semaines de traitement pour soulager les signes et les symptômes de l'arthrose de la hanche, comme en témoignent les 3 variables d'efficacité primaires. Ces résultats reflètent ceux observés dans la phase 3 autres études et de démontrer un bénéfice clinique après traitement naproxcinod dans l'indication plus difficile de l'arthrose de la hanche. Le naproxcinod a été bien toléré avec un profil similaire au placebo BP, alors que le naproxène a augmenté BP par rapport au placebo.
ugotega
Forumer storico
da notare:
il campione per gli studi 303 (artrosi all'anca per 13 settimane 810 pazienti) è composto per il 97% da persone caucase, per cui è provabile che gli studi siano stati condotti nel paese ex urss
non si parla di non inferiorità dell'efficacia rispetto a naproxene ma di risultati simili al naproxene...
doctor NO
NO nel DNA
http://media.pfizer.com/files/news/press_releases/2010/celebrex_condor_061710.pdf
leggetevi le controindicazioni del celebrex!!!!!!!!!!!!!!!!! Il tutto pubblicato settimana scorsa sul sito Pfizer!!!!!!!!!!!!!!!!!! Ma non è che si apprestano a fare un mea culpa per poi sostituirlo con il naproxcinod????????????? Certo che lasciare in circolazione il celebrex e non permettere la commercializzazione al naproxcinod .................................
leggetevi le controindicazioni del celebrex!!!!!!!!!!!!!!!!! Il tutto pubblicato settimana scorsa sul sito Pfizer!!!!!!!!!!!!!!!!!! Ma non è che si apprestano a fare un mea culpa per poi sostituirlo con il naproxcinod????????????? Certo che lasciare in circolazione il celebrex e non permettere la commercializzazione al naproxcinod .................................
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