Jeg mener ikke, at disse tidligere har været nævnt her (fra Clinical Trials):
Ofatumumab in Nodular Lymphocyte Predominant Hodgkin Lymphoma (NLPHL)
This study is not yet open for participant recruitment.
Verified by University of Cologne, August 2010
Study to Investigate CAL-101 in Combination With Bendamustine and CD20 mAb in Patients With Relapsed or Refractory Indolent B-cell Non-Hodgkin's Lymphoma or Chronic Lymphocytic Leukemia
This study is currently recruiting participants.
Verified by Calistoga Pharmaceuticals, Inc., August 2010
I sidstnævnte sammenlignes blandt andet en arm med Rituximab mod en arm med Ofatumumab
Nye forsøg - indenfor de sidste 14 dage mener jeg:
http://clinicaltrials.gov/ct2/show/NCT01190449?term=arzerra&rank=25
http://clinicaltrials.gov/ct2/show/NCT01187303?term=arzerra&rank=34
http://clinicaltrials.gov/ct2/show/NCT01088048?term=arzerra&rank=40
Med hhv 100, 30 og 96 patienter
Vi mangler stadig de mange forventede fase 2 forsøg i reumatiske sygdomme i s.c. version !
http://clinicaltrials.gov/ct2/show/NCT01190449?term=arzerra&rank=25
http://clinicaltrials.gov/ct2/show/NCT01187303?term=arzerra&rank=34
http://clinicaltrials.gov/ct2/show/NCT01088048?term=arzerra&rank=40
Med hhv 100, 30 og 96 patienter
Vi mangler stadig de mange forventede fase 2 forsøg i reumatiske sygdomme i s.c. version !
Mig bekendt har denne ikke tidligere været omtalt. Ofatumumab ER bare bedst!!
Journal of Clinical Oncology, 2010 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 28, No 15_suppl (May 20 Supplement), 2010: 8095
© 2010 American Society of Clinical Oncology
Activity of ofatumumab (OFA), a fully human monoclonal antibody targeting CD20, against rituximab (RTX)-sensitive (RSCL) and rituximab-resistant cell lines (RRCL), in vivo, and primary tumor cells derived from patients with B-cell lymphoma.
M. J. Barth, F. J. Hernandez-Ilizaliturri, C. Mavis, P. Tsai, J. F. Gibbs and M. S. Czuczman
Roswell Park Cancer Institute, Buffalo, NY
Abstract
8095
Background: RTX has changed the treatment paradigm for B-cell neoplasms and is associated with improved outcomes, but also appears to be changing the sensitivity of relapsed lymphoma. OFA is a new mAb that targets a novel membrane-proximal epitope on CD20. OFA has received marketing approval in the US for fludarabine and alemtuzumab refractory CLL, and is currently evaluated in several clinical trials. To better define OFA's activity, we conducted pre-clinical studies in a panel of RSCL, RRCL, primary lymphoma cells (n=17), and in vivo.
Methods: RRCL were generated by repeated exposure (i.e. 10 passages) of sensitive cells to escalating doses of RTX ± human serum. Antibody- dependant cellular cytotoxicity (ADCC) and complement-mediated cytotoxicity (CMC) assays were performed to demonstrate changes in sensitivity to RTX. Lymphoma cells were labeled with 51Cr prior to incubation with RTX or OFA (1 or 10 mg/ml) plus human serum. 51Cr-release was measured and the percentage of lysis was calculated. Surface CD20 levels were determined by flow cytometry. SCID mice were inoculated via tail vein with Raji cells (day 0) and assigned to observation versus 4 doses of either OFA or RTX (1 or 10mg/kg/dose).
Results: OFA was more potent than RTX in elucidating effective CMC at the doses tested not only in RSCL, but also in all RRCL (all passages) tested. OFA was more active than RTX in killing tumor cells derived from patients with de novo or relapsed B-cell lymphoma. In addition, OFA was more effective in controlling in vivo lymphoma growth than RTX. The median survival for animals treated with OFA (1 or 10mg/kg/dose) [58 and 77 days] was longer than those treated with RTX [40 and 50 days]. While the activity of RTX diminished with CD20 down-regulation in RRCL passages, OFA activity was preserved even at low CD20 levels.
Conclusions: Our data suggest that OFA is more potent than RTX not only in RTX-sensitive but also in RTX-resistant models. We are currently evaluating the biological effects of OFA in combination with a panel of chemotherapeutic agents and target-specific small molecule inhibitors.
http://meeting.ascopubs.org/cgi/content/abstract/28/15_suppl/8095
Journal of Clinical Oncology, 2010 ASCO Annual Meeting Proceedings (Post-Meeting Edition).
Vol 28, No 15_suppl (May 20 Supplement), 2010: 8095
© 2010 American Society of Clinical Oncology
Activity of ofatumumab (OFA), a fully human monoclonal antibody targeting CD20, against rituximab (RTX)-sensitive (RSCL) and rituximab-resistant cell lines (RRCL), in vivo, and primary tumor cells derived from patients with B-cell lymphoma.
M. J. Barth, F. J. Hernandez-Ilizaliturri, C. Mavis, P. Tsai, J. F. Gibbs and M. S. Czuczman
Roswell Park Cancer Institute, Buffalo, NY
Abstract
8095
Background: RTX has changed the treatment paradigm for B-cell neoplasms and is associated with improved outcomes, but also appears to be changing the sensitivity of relapsed lymphoma. OFA is a new mAb that targets a novel membrane-proximal epitope on CD20. OFA has received marketing approval in the US for fludarabine and alemtuzumab refractory CLL, and is currently evaluated in several clinical trials. To better define OFA's activity, we conducted pre-clinical studies in a panel of RSCL, RRCL, primary lymphoma cells (n=17), and in vivo.
Methods: RRCL were generated by repeated exposure (i.e. 10 passages) of sensitive cells to escalating doses of RTX ± human serum. Antibody- dependant cellular cytotoxicity (ADCC) and complement-mediated cytotoxicity (CMC) assays were performed to demonstrate changes in sensitivity to RTX. Lymphoma cells were labeled with 51Cr prior to incubation with RTX or OFA (1 or 10 mg/ml) plus human serum. 51Cr-release was measured and the percentage of lysis was calculated. Surface CD20 levels were determined by flow cytometry. SCID mice were inoculated via tail vein with Raji cells (day 0) and assigned to observation versus 4 doses of either OFA or RTX (1 or 10mg/kg/dose).
Results: OFA was more potent than RTX in elucidating effective CMC at the doses tested not only in RSCL, but also in all RRCL (all passages) tested. OFA was more active than RTX in killing tumor cells derived from patients with de novo or relapsed B-cell lymphoma. In addition, OFA was more effective in controlling in vivo lymphoma growth than RTX. The median survival for animals treated with OFA (1 or 10mg/kg/dose) [58 and 77 days] was longer than those treated with RTX [40 and 50 days]. While the activity of RTX diminished with CD20 down-regulation in RRCL passages, OFA activity was preserved even at low CD20 levels.
Conclusions: Our data suggest that OFA is more potent than RTX not only in RTX-sensitive but also in RTX-resistant models. We are currently evaluating the biological effects of OFA in combination with a panel of chemotherapeutic agents and target-specific small molecule inhibitors.
http://meeting.ascopubs.org/cgi/content/abstract/28/15_suppl/8095
31/8 2010 09:25 colombuss 0
32638 Flot fundet. Så ser vi med sindsro frem til head to head undersøgelser, og at blockbuster potentialet bliver realiseret.
31/8 2010 12:41 gentogen 032649 Man kan også kigge lidt på:
http://www.communityoncology.net/journal/articles/0704151.pdf
http://www.communityoncology.net/journal/articles/0704151.pdf
31/8 2010 20:57 Solsen 032676 Endnu et forsøg:
http://clinicaltrials.gov/ct2/show/NCT01191190?term=arzerra&rank=3
41 ialt på søgningen.
Godt link Gentogen - bekræfter vores tiltro til Arzerra.
http://clinicaltrials.gov/ct2/show/NCT01191190?term=arzerra&rank=3
41 ialt på søgningen.
Godt link Gentogen - bekræfter vores tiltro til Arzerra.
31/8 2010 21:35 gentogen 032677 Vi er jo snart nødt til at læse Clinical Trials hver dag! Vi er åbenbart ikke helt alene i verden i troen på Ofatumumab.....
Der bliver også skrevet rigtig mange artikler om Ofatumumab. Denne her er også ganske god, synes jeg (fra februar i år).
http://www.dovepress.com/getfile.php?fileID=5809.
Der bliver også skrevet rigtig mange artikler om Ofatumumab. Denne her er også ganske god, synes jeg (fra februar i år).
http://www.dovepress.com/getfile.php?fileID=5809.
dit link dur ikke gentogen. Men jeg tager nu hellere strategi oplægget om et par uger.
1/9 2010 00:45 gentogen 032686 Jeg prøver lige igen.....
http://www.dovepress.com/the-role-of-ofatumumab-in-the-treatment-of-chronic-lymphocytic-leukemi-peer-reviewed-article-JBM
I øvrigt er jeg da med på, at vi har indledt de sidste 14 dages ventetid på sidste ny strategi. Dette er da også blot lidt læsestof til ventetiden. Ikke desto mindre forekommer det mig, at det er særdeles positivt med mange positive videnskabelige artikler her i 2010 (i direkte modstrid med markedets vurdering det sidste årstid), mange nye partnere i studierne og GSKs engagement, de gode historier fra patienthjemmesider etc.
http://www.dovepress.com/the-role-of-ofatumumab-in-the-treatment-of-chronic-lymphocytic-leukemi-peer-reviewed-article-JBM
I øvrigt er jeg da med på, at vi har indledt de sidste 14 dages ventetid på sidste ny strategi. Dette er da også blot lidt læsestof til ventetiden. Ikke desto mindre forekommer det mig, at det er særdeles positivt med mange positive videnskabelige artikler her i 2010 (i direkte modstrid med markedets vurdering det sidste årstid), mange nye partnere i studierne og GSKs engagement, de gode historier fra patienthjemmesider etc.
1/9 2010 10:30 colombuss 032709 Hvor jeg ærger mig over at man skal lege gen pudslespil i så mange tråde, selv om det giver klik og indlæg til Pro, ville det nu være dejligt med nyt indlæg først, så disse info kom lige op til overfladen. hurtigt.
6/9 2010 20:07 masha 032957 http://www.gsk.com/investors/product_pipeline/docs/GSK-product-pipeline-Feb-2010.pdf synes da at indikere at der er langt flere studier med Genmabs produkter involveret end hvad jeg havde opdaget. Men måske skal pipelinen bare opdateres så de forsvinder igen?
hej masha, faktisk er der mange flere. hvilke nogen undrer du dig over?
6/9 2010 23:13 masha 032967 ofatumumab anti-CD20 human monoclonal antibody rheumatoid arthritis lll - var denne ikke dømt død - det er jo her de helt store penge kan ligge!
7/9 2010 17:55 Solsen 032981 De store penge ligger i s.c. i MS og RA - derfor var GSK også tilfredse med at give Genmab en stor pose penge for at nedsætte royalty og milestones.
Nu 43 forsøg.... 2 nye hhv 120 og 66 patienter
http://clinicaltrials.gov/ct2/show/NCT01195714?term=arzerra&rank=41
http://clinicaltrials.gov/ct2/show/NCT01195766?term=arzerra&rank=39
Nu 43 forsøg.... 2 nye hhv 120 og 66 patienter
http://clinicaltrials.gov/ct2/show/NCT01195714?term=arzerra&rank=41
http://clinicaltrials.gov/ct2/show/NCT01195766?term=arzerra&rank=39
3/10 2010 20:40 Solsen 034356 Nu 44 forsøg....
http://clinicaltrials.gov/ct2/results?term=arzerra
og AMG-714 lever endnu til min store overraskelse.
http://clinicaltrials.gov/archive/NCT00443326
http://clinicaltrials.gov/ct2/results?term=arzerra
og AMG-714 lever endnu til min store overraskelse.
http://clinicaltrials.gov/archive/NCT00443326
8/10 2010 21:58 Solsen 034593 så 45 forsøg
http://clinicaltrials.gov/ct2/show/NCT01217749?term=arzerra&rank=45
Nedtælling til salgstal og MS konference med data fra s.c. version af arzerra
http://clinicaltrials.gov/ct2/show/NCT01217749?term=arzerra&rank=45
Nedtælling til salgstal og MS konference med data fra s.c. version af arzerra
