Vi har jo selvfølgelig vores fyldige Asco program fra d.7 juni og frem, men deruodver er de altså gået i max promotion mode.
Genmab to Present at Three June Investor Conferences
Copenhagen, Denmark; May 28, 2010 - Genmab A/S (OMX: GEN) announced today its management will present at three investor conferences in June 2010.
June 11 - CFO David Eatwell will present at the Jefferies 2010 Global Life Sciences Conference in New York, NY at 1:15 PM local time.
June 16 - CEO Lisa N. Drakeman, Ph.D. will present at the Goldman Sachs 31st Annual Global Healthcare Conference in Los Angeles, CA at 11:20 AM local time.
June 22 - CEO Lisa N. Drakeman, Ph.D. will present at the Piper Jaffray European Healthcare Conference in London, UK at 8:30 AM local time.
Genmab to Present at Three June Investor Conferences
Copenhagen, Denmark; May 28, 2010 - Genmab A/S (OMX: GEN) announced today its management will present at three investor conferences in June 2010.
June 11 - CFO David Eatwell will present at the Jefferies 2010 Global Life Sciences Conference in New York, NY at 1:15 PM local time.
June 16 - CEO Lisa N. Drakeman, Ph.D. will present at the Goldman Sachs 31st Annual Global Healthcare Conference in Los Angeles, CA at 11:20 AM local time.
June 22 - CEO Lisa N. Drakeman, Ph.D. will present at the Piper Jaffray European Healthcare Conference in London, UK at 8:30 AM local time.
31/5 2010 13:22 gentogen 0
29783 PLUS
3rd Annual Antibody Discovery and Development Forum - June 17-18, 2010...»
3rd Annual Antibody Discovery and Development Forum - June 17-18, 2010...»
31/5 2010 16:43 gentogen 029790 Når Genmab omhyggeligt vælger at offentliggøre deres abstract vedrørende Zalutumumab på ASCO konferencen på en fredag efter dansk børsluk, så er det vel nærliggende at se det som et udtryk for, at de vurderer, at dette abstract indeholder information, der er ny i forhold til allerede kendt information. Eller hvad?? Jeg mener: Langt de fleste abstracts offentliggøres jo bare?
Jeg tror ikke man skal lægge noget i det. Hvis de tror at det har kurspåvirkende effekt skal det offentliggøres med det samme at Genmab bliver bekendt med resultaterne. Så jeg tror ikke at man kan læse noget ud af det.
Til gengæld tror jeg at det kommer til at gå vildt for sig hvis de annoncerer de går videre med filing.
Til gengæld tror jeg at det kommer til at gå vildt for sig hvis de annoncerer de går videre med filing.
31/5 2010 18:57 HRmunk 029801 Zalutumumab efter børsluk lugter af opgivelse eller hvad? Jeg er ikke tryg.
31/5 2010 19:53 Solsen 029803 Investorerne har opgivet Zalutumumab - måske lige bortset fra aka og undertegnede 
Opgivelse kan ikke blive en negativ trigger.
Men aftale med FDA/Emea om filing og dermed licensaftale i nær fremtid vil være posistivt !!!
Opgivelse kan ikke blive en negativ trigger.
Men aftale med FDA/Emea om filing og dermed licensaftale i nær fremtid vil være posistivt !!!
Det er noget nær utænkeligt at de vil gå til asco for at give stoffet op. Den tror jeg ikke på
31/5 2010 20:15 Stinker 029805 Eftersom Zalutumumabpræsentationen er mundtlig (modsat alle Ofatumumab præsentationerne, der blot er poster sessions) og den er optaget på ASCO-konferencen som et "late breaking abstract" sigter præsentationen med garanti ikke mod opgivelse af Zalutumumab.
Abstractet må antages at indeholde del uddybende informationer om resultatet af fase III forsøget i SCCHN, som vi jo faktisk kun fik præsenteret ganske overfladisk ved meddelelsen om dets afslutning, og spørgsmålet må vel defor være om disse informationer vil danne grundlag for nye forsøg eller filing.
Abstractet må antages at indeholde del uddybende informationer om resultatet af fase III forsøget i SCCHN, som vi jo faktisk kun fik præsenteret ganske overfladisk ved meddelelsen om dets afslutning, og spørgsmålet må vel defor være om disse informationer vil danne grundlag for nye forsøg eller filing.
Eftersom investorerne har opgivet Zalutumumab totalt, kan der ganske rigtigt ikke komme en negativ trigger ud af det. HVIS de opgiver det, så sparer Genmab 100 millioner om året i udviklingsomkostninger og HVIS de går videre, så tjener de forhåbentlig 500 på en aftale. Det er ren win win.......(smil)
Mig bekendt har konkurrenten ikke leveret bedre data, så situationen er vel ret åben.
Mig bekendt har konkurrenten ikke leveret bedre data, så situationen er vel ret åben.
1/6 2010 11:13 troldmanden 029834 Ork jo det er lige så sikkert som ammen i kirken at hvis Genmab vælger officielt at nedlægge projektet så kommer kursen til at falde en del.
Det er set SÅ mange gange før at et selskab gennem lang tid holder liv i et nøgle program selvom stort set alle analytikere har afskrevet det i deres økonomiske modeller. Men når stikket så endeligt trækkes ud så falder aktien alligevel.
Der vil ske præcis det samme i Neurosearch hvis/når de vælger at trække stikket til Tesofensine. Her har stort set alle analytikerne også valgt kun i meget beskeden omfang at indregne projektet
Jeg tror do ikke Genmap er der hvor de vil træffe en sådan beslutning. De vil helt sikekrt afvente yderligere data.
En anden ting. Vi ser ofte en positiv effekt når et selskab indtræder i C20. Men er der nogen der har set på effekten når et selskab udtræder?. Altså sker salget af fra de fonde der investere i C20 tier forud for den endelige afgørelse eller er det først bagefter?
Det er set SÅ mange gange før at et selskab gennem lang tid holder liv i et nøgle program selvom stort set alle analytikere har afskrevet det i deres økonomiske modeller. Men når stikket så endeligt trækkes ud så falder aktien alligevel.
Der vil ske præcis det samme i Neurosearch hvis/når de vælger at trække stikket til Tesofensine. Her har stort set alle analytikerne også valgt kun i meget beskeden omfang at indregne projektet
Jeg tror do ikke Genmap er der hvor de vil træffe en sådan beslutning. De vil helt sikekrt afvente yderligere data.
En anden ting. Vi ser ofte en positiv effekt når et selskab indtræder i C20. Men er der nogen der har set på effekten når et selskab udtræder?. Altså sker salget af fra de fonde der investere i C20 tier forud for den endelige afgørelse eller er det først bagefter?
1/6 2010 11:33 Sukkeralf 029837 Enig med et fald hvis Zalutumumab opgives helt, for den slags koster altid på kursen uanset hvad - i hvert fald på den korte bane. Et gæt er omkring 10% ned !
Ligeledes spændende hvad det betyder at Genmab ryger ud af OMXC20 - tror nu ikke det bliver voldsomt på den korte bane (måske 3-5%), men spørgsmålet er hvad en evt. manglende interesse fra større investorer kan betyde på den langt sigt.
Der skal snart nogle gode data på bordet, så der kan komme lidt tro og forhåbninger i aktien igen.
Mvh
Sukkeralf
Ligeledes spændende hvad det betyder at Genmab ryger ud af OMXC20 - tror nu ikke det bliver voldsomt på den korte bane (måske 3-5%), men spørgsmålet er hvad en evt. manglende interesse fra større investorer kan betyde på den langt sigt.
Der skal snart nogle gode data på bordet, så der kan komme lidt tro og forhåbninger i aktien igen.
Mvh
Sukkeralf
1/6 2010 11:59 troldmanden 029838 Ja jeg tror også en nedlukning af zalu hurtigt kan koste 10% på den korte bane inden den retter sig igen. Men tror om sagt ikke det ligger i kortene. Dertil er der stadig for mange muligheder med stoffet omend de finansieringsmæssigt ikke rigtigt har råd til selv at sætte nye forsøg i gang. Så jeg tror stadig vi vil se dem finde en parnter i løbet af 2011
Ja i samme øjeblik et selskab udtræder af C20 så er der en række fonde/investorer der slet ikke finder det interessant/relevant at holde aktien mere. Det store spørgsmål er som sagt bare om de allerede har solgt ud.
Og ja genmab og næsten hele den danske biotech branche sukker lige nu efter positive nyheder. For Genmab skal vi ind i 2. halvår før der kommer nyt. Jo før fabrikssalget komme des do bedre og mere positivt
Har du genmab aktier nu Sukkeralf?
Ja i samme øjeblik et selskab udtræder af C20 så er der en række fonde/investorer der slet ikke finder det interessant/relevant at holde aktien mere. Det store spørgsmål er som sagt bare om de allerede har solgt ud.
Og ja genmab og næsten hele den danske biotech branche sukker lige nu efter positive nyheder. For Genmab skal vi ind i 2. halvår før der kommer nyt. Jo før fabrikssalget komme des do bedre og mere positivt
Har du genmab aktier nu Sukkeralf?
Og på 5 års low. Det er jo et udtryk for at der er minus sentiment i aktien.
I forhold til Zalutumumab, så er det 100% givet at der ingen forventninger er til stoffet indregnet i kursen, men også 100% sikkert at vi falder hvis det opgives. Sådan er markedet. Der vil også komme en ex-oms effekt, men den tror jeg bliver meget marginal.
Spørgsmålet er om salgstallene kan andet end at overraske. Så er der ligelede en del aktivitet i juni måned, som måske kan få lidt buzz til at ske og endeligt må vi sige at GSK må kigge på at overtage genmab i 150-200. Det regnestykke må gå op.
I forhold til Zalutumumab, så er det 100% givet at der ingen forventninger er til stoffet indregnet i kursen, men også 100% sikkert at vi falder hvis det opgives. Sådan er markedet. Der vil også komme en ex-oms effekt, men den tror jeg bliver meget marginal.
Spørgsmålet er om salgstallene kan andet end at overraske. Så er der ligelede en del aktivitet i juni måned, som måske kan få lidt buzz til at ske og endeligt må vi sige at GSK må kigge på at overtage genmab i 150-200. Det regnestykke må gå op.
1/6 2010 13:18 Sukkeralf 029841 Jep - er aktionær på den lange bane med en slat !!
Købt på forventninger om positive Arzerra og venter stadig på dem
Efter en super flot start for biotek i år, så har branchen vist fået en ordentlig mavepumper efterfølgende - ikke mindst på grund af NS.
Mvh
Sukkeralf
Købt på forventninger om positive Arzerra og venter stadig på dem
Efter en super flot start for biotek i år, så har branchen vist fået en ordentlig mavepumper efterfølgende - ikke mindst på grund af NS.
Mvh
Sukkeralf
Der er da også grund til positiove forventninger. Optimismen stiger yderligere på cll diary, hvor patienten i dag skriver:
On Thursday the 20th, I had 1000 mg of Arzerra. Over the next four or five days, the switch went on. I began losing weight, and my neck and abdomen showed visible progress.
But the best example of change was the nodal mass under my right arm. What had been a hard baseball-like thing (well, half a baseball) -- a number of nodes that had grown together -- simply fell apart. I can feel individual nodes there now, but they're no longer connected.
On Thursday the 20th, I had 1000 mg of Arzerra. Over the next four or five days, the switch went on. I began losing weight, and my neck and abdomen showed visible progress.
But the best example of change was the nodal mass under my right arm. What had been a hard baseball-like thing (well, half a baseball) -- a number of nodes that had grown together -- simply fell apart. I can feel individual nodes there now, but they're no longer connected.
Det er dejligt at høre disse patient historier, selvom jeg synes der er for få af dem. Men det er helt sikkert meget meget befriende læsning.
Keep it Coming !
Keep it Coming !
1/6 2010 13:33 gentogen 029846 Glemte lige linket, men det kender I vel...
http://clldiary.blogspot.com/
http://clldiary.blogspot.com/
1/6 2010 13:39 troldmanden 029847 Jeg regner også med jeg skal have købt mig en langsigtet beholdning indenfor de næste par mdr. Men tror jeg kan fange den længere nede end nu da jeg ikke umiddelbart ser nogle positive triggers på den korte bane. Og med den dårlige stemning der pt er omkring aktien så kan det godt være yderligere gift for kursen når de positive nyheder udebliver
Ja NS er helt sikkert medskyldig i den pludselige negative stemning omkring biotch. De har en kæmpe opgave foran sig med at få rettet skuden op igen. Og FPs meget pludselige skifte gør ikke just opgaven mindre. Tvært i mod.
Prøv evt at se den seneste præsentation fra dem. Du kan finde den her http://www.proinvestor.com/aktier/Neurosearch/NEUR.CO
Der er flere nye detaljer på den. Men det kan vi evt drøfte i en NS råd frem for genmab tråd
Ja NS er helt sikkert medskyldig i den pludselige negative stemning omkring biotch. De har en kæmpe opgave foran sig med at få rettet skuden op igen. Og FPs meget pludselige skifte gør ikke just opgaven mindre. Tvært i mod.
Prøv evt at se den seneste præsentation fra dem. Du kan finde den her http://www.proinvestor.com/aktier/Neurosearch/NEUR.CO
Der er flere nye detaljer på den. Men det kan vi evt drøfte i en NS råd frem for genmab tråd
Arzerra styrer bare.
Akkurat som i andre, mener jeg ikke det ligger i kortene at Zalutumumab opgives. Jeg tror snarere at der kommer en redegørelse, eller en uddybning omkring resultaterne og at der er liv i mulighederne. Måske nye afprøvninger eller grundlag for videre ansøgning.
Skulle det ske, at de opgiver Zalu vil det midlertidigt give et dyk i kursen. Genmab er dog så langt nede, at jeg mener de afgjort har potentiale.
Jeg har brugt lidt tid på at indsamle egne info om Arzerra, både på nettet og andet.
Alle steder dukker der vinkler op omkring Arzerra og det bliver efterhånden klart fremhævet positivt i CLL verdenen. Flere steder sammenligner man med Rituxan og fremhæver Arzerra som mindst lige så effektiv men med klart mindre bivirkninger. Det at man oftere skriver positivt om Arzerra i diverse fora gør, at flere og flere ønsker at vælge dette. Det kan få betydning for kombinationsbehandling, second line og for den sags skyld i andre indikationer.
Der er noget som går igen, bl.a. at opstarten med de første behandlinger går stille af hvorefter virkningen bliver bedre og bedre. At der virkelig sker en forbedring ved den høje dosis og at bivirkningerne, eller mangel på samme, er det helt store hit. Ikke mindst dette vil kunne flytte patienter og behandleres fokus, idet alle vil vide det efter en tid.
Jeg tror vi ser starten på en trend, hvor salget vil eskalere.
Vedhæfter lige nogle få klip fra diverse sider Læs selv hele teksterne:
CLLdiary.blogspot.com
TUESDAY, JUNE 01, 2010
At last, progress on the nodes
"Good news, everyone!"
Fans of Futurama and its doddering professor and sometime inventor Hubert J. Farnsworth will recognize that expression and know the voice that goes with it. If I may take a little more liberty in the style of the good professor:
"The Lenalidomide-Ofatumumab Leukemi-o-meter De-noder appears to be working!"
The last thing I expected was that progress would be sudden. But it has been, like turning on a light switch. I alluded to it in my last post, which was mainly concerned with a Revlimid-induced rash that I had developed.
In the week prior to my May 20 monthly Arzerra infusion, I had finally managed to get my Revlimid dose up to 10 mg daily, which is what the protocol calls for. This obviously raised the levels of the drug in my body (ergo the rash). I began to suspect some subtle progress on the nodes in my neck. On Thursday the 20th, I had 1000 mg of Arzerra. Over the next four or five days, the switch went on. I began losing weight, and my neck and abdomen showed visible progress.
But the best example of change was the nodal mass under my right arm. What had been a hard baseball-like thing (well, half a baseball) -- a number of nodes that had grown together -- simply fell apart. I can feel individual nodes there now, but they're no longer connected.
I'm making an educated guess that this could be going on in the abdomen, which has slimmed down considerably. I'm still full of nodes, but the masses may be breaking apart as each node reduces in size. My neck is looking positively scrawny as a mass on the right side has undergone a similar fate.
Why the Arzerra chose that weekend to kick in, I don't know. To give my body a break from the rash, I was off Revlimid from May 20 until the night of May 24. But levels of the drug, which had been building while I was managing 10 mg daily, had to have been high on May 20, the day of the Arzerra infusion. Revlimid is an immunomodulator and perhaps it had sufficiently started to change the microenvironment in which my CLL cells live and my immune system functions, creating a more advantageous environment for the Arzerra. That's only a guess. (If the experts don't know how it works, I don't think I'm going to figure it out.) Whether that modulation has do to with dosage levels or length of time used, I can't know for sure, although it stands to reason that both are a factor and that dosage is important.
That's why I am anxious to get to and stay at the optimal dose of 10 mg daily. We all respond differently to drugs and their dosages. A tiny dose of vincristine, which probably would have gone unnoticed in another patient, once gave me peripheral neuropathy for months. Claritin, the allergy medicine, doesn't work for me at all at the recommended dose. If I exceed that dose and take two Claritin, it does work. So in the case of one drug I am more sensitive than average, in the case of the other I am less so.
But the bottom line is that the underlying progress is a result of the OL (ofatumumab-lenalidomide) protocol. Why or how it suddenly decided to visibly work after three months is a Farnsworthian mystery. My advice to those starting Revlimd and Arzerra is to hold on, get ready for the long haul, and be aware that you may not see immediate results like you do with most treatments. That makes it a little counterintuitive and a little hard to take at times, but you might just be surprised one day. I certainly am.
Fra 27 maj 2010:
http://updates.clltopics.org/2226-fc-versus-fcr
If you are a late stage CLL patient looking at your therapy options and your guy tells you the best option is FC (Fludarabine+cyclophosphamide), please tell him you would rather have FCR (R for Rituxan). Or the FC+O combination, where the new monoclonal antibody ofatumumab (also known as Arzerra, Humax-cd20) replaces Rituxan. While ofatumumab has far less track record than Rituxan and that is an issue worth remembering, there are some reasons for hoping that being a fully humanized antibody, ofatumumab may have fewer adverse effects and may have higher efficacy. As you probably know, Rituxan has snippets of mouse protein in it and some patients develop hypersensitivity to it. My husband PC was one of them. Back then we had to go to the UK to get access to ofatumumab. Now that the FDA has approved it, patients can get access to it in the comfort of their home towns
23 maj 2010 http://community.lls.org/
Efter 10 behandlinger med Arzerra:
CONCLUSIONS
HGB - I am definitely happy with the results. I am now at a good level and have not had blood transfusion in the last 5 months. Hopefully they will stay at these levels.
ANC-I was happy with the counts during the weekly infusions but I am unhappy with the drop off during the monthly infusions. I suspect these will remain a problem.
WBC-has not been a problem and no change during the infusions.
PLATELETS-the increase in platelet count was pleasant surprise and while they still remain low, they are better than they have been for a long time. I hope this continues.
I had no serious side affects from the infusions, no pains, no loss of hair, no tiredness, no up set stomach. I had an occasional diarrhea but not sure that was from the infusions.
First infusion took 8.5 hours as they had to slowly increase the drip rate and monitor for any side affects. After that the infusions only took 6 hours and as I have a port they were no trouble, just boring.
While I am not in remission I am happy with relief it has brought me over the last five months. I am hopeful it will continue over the summer as I do some traveling. I will just have to wait and see how long the effects last. In the mean time I will continue searching and looking for the next plan of attack, while maintaining a positive attitude and enjoying every day.
Fred
Case History of a Relapsed CLL patient
Chaya Venkat
4. april 2010
Many clinical trials are going on to see if the ability of Revlimid to increase T-cell and NK-cell function means it can give Rituxan or Arzerra a more effective helping hand. Remember, we said both Rituxan and Arzerra depend on the immune system to do the actual cell kill of CLL cells. They do the tagging, Revlimid supplies the T-cell and NK-cell troops to do the actual killing. Sweet concept, I hope it proves to be the case.
So, that is my advice to Sarah; that she should talk to her doctors about low dose Revlimid therapy, either by itself or in combination with Rituxan (or Arzerra). And that she should consider starting sooner rather than later, in order to possibly avoid massive tumor flare reactions. Unlike Campath and fludarabine which will further demolish her T-cells and NK-cells, Revlimid may actually build up these immune defenses, give her additional protection against opportunistic infections, especially viral infections. The neutropenia that seems to be built into the cake with Revlimid therapy can be controlled with prudent use of Neupogen or Neulasta shots. Staying away from standard chemotherapy drugs may also increase her chances of avoiding secondary cancers.
Akkurat som i andre, mener jeg ikke det ligger i kortene at Zalutumumab opgives. Jeg tror snarere at der kommer en redegørelse, eller en uddybning omkring resultaterne og at der er liv i mulighederne. Måske nye afprøvninger eller grundlag for videre ansøgning.
Skulle det ske, at de opgiver Zalu vil det midlertidigt give et dyk i kursen. Genmab er dog så langt nede, at jeg mener de afgjort har potentiale.
Jeg har brugt lidt tid på at indsamle egne info om Arzerra, både på nettet og andet.
Alle steder dukker der vinkler op omkring Arzerra og det bliver efterhånden klart fremhævet positivt i CLL verdenen. Flere steder sammenligner man med Rituxan og fremhæver Arzerra som mindst lige så effektiv men med klart mindre bivirkninger. Det at man oftere skriver positivt om Arzerra i diverse fora gør, at flere og flere ønsker at vælge dette. Det kan få betydning for kombinationsbehandling, second line og for den sags skyld i andre indikationer.
Der er noget som går igen, bl.a. at opstarten med de første behandlinger går stille af hvorefter virkningen bliver bedre og bedre. At der virkelig sker en forbedring ved den høje dosis og at bivirkningerne, eller mangel på samme, er det helt store hit. Ikke mindst dette vil kunne flytte patienter og behandleres fokus, idet alle vil vide det efter en tid.
Jeg tror vi ser starten på en trend, hvor salget vil eskalere.
Vedhæfter lige nogle få klip fra diverse sider Læs selv hele teksterne:
CLLdiary.blogspot.com
TUESDAY, JUNE 01, 2010
At last, progress on the nodes
"Good news, everyone!"
Fans of Futurama and its doddering professor and sometime inventor Hubert J. Farnsworth will recognize that expression and know the voice that goes with it. If I may take a little more liberty in the style of the good professor:
"The Lenalidomide-Ofatumumab Leukemi-o-meter De-noder appears to be working!"
The last thing I expected was that progress would be sudden. But it has been, like turning on a light switch. I alluded to it in my last post, which was mainly concerned with a Revlimid-induced rash that I had developed.
In the week prior to my May 20 monthly Arzerra infusion, I had finally managed to get my Revlimid dose up to 10 mg daily, which is what the protocol calls for. This obviously raised the levels of the drug in my body (ergo the rash). I began to suspect some subtle progress on the nodes in my neck. On Thursday the 20th, I had 1000 mg of Arzerra. Over the next four or five days, the switch went on. I began losing weight, and my neck and abdomen showed visible progress.
But the best example of change was the nodal mass under my right arm. What had been a hard baseball-like thing (well, half a baseball) -- a number of nodes that had grown together -- simply fell apart. I can feel individual nodes there now, but they're no longer connected.
I'm making an educated guess that this could be going on in the abdomen, which has slimmed down considerably. I'm still full of nodes, but the masses may be breaking apart as each node reduces in size. My neck is looking positively scrawny as a mass on the right side has undergone a similar fate.
Why the Arzerra chose that weekend to kick in, I don't know. To give my body a break from the rash, I was off Revlimid from May 20 until the night of May 24. But levels of the drug, which had been building while I was managing 10 mg daily, had to have been high on May 20, the day of the Arzerra infusion. Revlimid is an immunomodulator and perhaps it had sufficiently started to change the microenvironment in which my CLL cells live and my immune system functions, creating a more advantageous environment for the Arzerra. That's only a guess. (If the experts don't know how it works, I don't think I'm going to figure it out.) Whether that modulation has do to with dosage levels or length of time used, I can't know for sure, although it stands to reason that both are a factor and that dosage is important.
That's why I am anxious to get to and stay at the optimal dose of 10 mg daily. We all respond differently to drugs and their dosages. A tiny dose of vincristine, which probably would have gone unnoticed in another patient, once gave me peripheral neuropathy for months. Claritin, the allergy medicine, doesn't work for me at all at the recommended dose. If I exceed that dose and take two Claritin, it does work. So in the case of one drug I am more sensitive than average, in the case of the other I am less so.
But the bottom line is that the underlying progress is a result of the OL (ofatumumab-lenalidomide) protocol. Why or how it suddenly decided to visibly work after three months is a Farnsworthian mystery. My advice to those starting Revlimd and Arzerra is to hold on, get ready for the long haul, and be aware that you may not see immediate results like you do with most treatments. That makes it a little counterintuitive and a little hard to take at times, but you might just be surprised one day. I certainly am.
Fra 27 maj 2010:
http://updates.clltopics.org/2226-fc-versus-fcr
If you are a late stage CLL patient looking at your therapy options and your guy tells you the best option is FC (Fludarabine+cyclophosphamide), please tell him you would rather have FCR (R for Rituxan). Or the FC+O combination, where the new monoclonal antibody ofatumumab (also known as Arzerra, Humax-cd20) replaces Rituxan. While ofatumumab has far less track record than Rituxan and that is an issue worth remembering, there are some reasons for hoping that being a fully humanized antibody, ofatumumab may have fewer adverse effects and may have higher efficacy. As you probably know, Rituxan has snippets of mouse protein in it and some patients develop hypersensitivity to it. My husband PC was one of them. Back then we had to go to the UK to get access to ofatumumab. Now that the FDA has approved it, patients can get access to it in the comfort of their home towns
23 maj 2010 http://community.lls.org/
Efter 10 behandlinger med Arzerra:
CONCLUSIONS
HGB - I am definitely happy with the results. I am now at a good level and have not had blood transfusion in the last 5 months. Hopefully they will stay at these levels.
ANC-I was happy with the counts during the weekly infusions but I am unhappy with the drop off during the monthly infusions. I suspect these will remain a problem.
WBC-has not been a problem and no change during the infusions.
PLATELETS-the increase in platelet count was pleasant surprise and while they still remain low, they are better than they have been for a long time. I hope this continues.
I had no serious side affects from the infusions, no pains, no loss of hair, no tiredness, no up set stomach. I had an occasional diarrhea but not sure that was from the infusions.
First infusion took 8.5 hours as they had to slowly increase the drip rate and monitor for any side affects. After that the infusions only took 6 hours and as I have a port they were no trouble, just boring.
While I am not in remission I am happy with relief it has brought me over the last five months. I am hopeful it will continue over the summer as I do some traveling. I will just have to wait and see how long the effects last. In the mean time I will continue searching and looking for the next plan of attack, while maintaining a positive attitude and enjoying every day.
Fred
Case History of a Relapsed CLL patient
Chaya Venkat
4. april 2010
Many clinical trials are going on to see if the ability of Revlimid to increase T-cell and NK-cell function means it can give Rituxan or Arzerra a more effective helping hand. Remember, we said both Rituxan and Arzerra depend on the immune system to do the actual cell kill of CLL cells. They do the tagging, Revlimid supplies the T-cell and NK-cell troops to do the actual killing. Sweet concept, I hope it proves to be the case.
So, that is my advice to Sarah; that she should talk to her doctors about low dose Revlimid therapy, either by itself or in combination with Rituxan (or Arzerra). And that she should consider starting sooner rather than later, in order to possibly avoid massive tumor flare reactions. Unlike Campath and fludarabine which will further demolish her T-cells and NK-cells, Revlimid may actually build up these immune defenses, give her additional protection against opportunistic infections, especially viral infections. The neutropenia that seems to be built into the cake with Revlimid therapy can be controlled with prudent use of Neupogen or Neulasta shots. Staying away from standard chemotherapy drugs may also increase her chances of avoiding secondary cancers.
1/6 2010 18:33 troldmanden 029868 Fint indlæg og god research
Det ligger ret fast at Genmab ikke har råd til selv at igangssætte nye kliniske forsøg me Zalu. Så det sker først når/hvis der kommer en ny partner ind. Ind til da fortsætter de med de igangværende forsøg og analysere videre på det famøse fase 3 forsøg.
Vh
T.
Det ligger ret fast at Genmab ikke har råd til selv at igangssætte nye kliniske forsøg me Zalu. Så det sker først når/hvis der kommer en ny partner ind. Ind til da fortsætter de med de igangværende forsøg og analysere videre på det famøse fase 3 forsøg.
Vh
T.
Før Fabrikken er solgt så rører Genmab ikke på opstart af nye forsøg. Og i deres nye strategi ligger også at de bringer 1(!) IND på banen om året.
Men tag nu ikke fejl. Antistoffer til partnerskaber er fortsat meget populære og Genmab har gode muligheder.
Og enig Arzerra styrer!!!
Men tag nu ikke fejl. Antistoffer til partnerskaber er fortsat meget populære og Genmab har gode muligheder.
Og enig Arzerra styrer!!!
1/6 2010 19:41 gentogen 029873 De videnskabelige artikler vælter snart over hinanden her i 2010. Et udvalg........
Ofatumumab Combined With Fludarabine and Cyclophosphamide (O-FC) Shows High Activity in Patients With Previously Untreated Chronic Lymphocytic Leukemia: Results From a Randomized, Multicenter, International, Two-Dose, Parallel-Group Phase II Trial
Journal Clinical Lymphoma, Myeloma & Leukemia
Publisher CIG Media Group, L.P.
ISSN 2152-2650 (Print) 2152-2669 (Online)
Issue Volume 10, Number 3 / June 2010
J Clin Oncol. 2010 Apr 1;28(10):1749-55. Epub 2010 Mar 1.
Ofatumumab as single-agent CD20 immunotherapy in fludarabine-refractory chronic lymphocytic leukemia.
Wierda WG, Kipps TJ, Mayer J, Stilgenbauer S, Williams CD, Hellmann A, Robak T, Furman RR, Hillmen P, Trneny M, Dyer MJ, Padmanabhan S, Piotrowska M, Kozak T, Chan G, Davis R, Losic N, Wilms J, Russell CA, Osterborg A; Hx-CD20-406 Study Investigators.
The University of Texas M.D. Anderson Cancer Center, Houston, TX 77030-4009, USA. [email protected]
Clin Adv Hematol Oncol. 2010 Jan;8(1):28-30.
Advances in LLM. Ofatumumab: a new agent for chronic lymphocytic leukemia.
Osterborg A.
Karolinska University Hospital, Karolinska Institutet, SE-171 77 Stockholm, Sweden.
Cancer Chemotherapy Update - Ofatumumab and Romidepsin
Journal Hospital Pharmacy
Publisher Thomas Land Publishers Inc.
ISSN 0018-5787
Issue Volume 45, Number 5 / May 2010
Category Cancer Chemotherapy Update
News and Analysis
Nature Reviews Drug Discovery 9, 101-102 (February 2010) ' doi:10.1038/nrd3100
FRESH FROM THE PIPELINE:
Ofatumumab
Michael J. Keating1, Argyris Dritselis2, Uma Yasothan2 & Peter Kirkpatrick
J Castillo - Journal of Blood Medicine, 2010 - dovepress.com
Ofatumumab for fludarabine- and
alemtuzumab-refractory CLL
A novel anti-CD20 monoclonal antibody produces durable remissions in patients with refractory chronic
lymphocytic leukemia
Summary by Matt Stenger, MS; reviewed by
Dhaval Mehta, MD, University of Pittsburgh
Cancer Institute, Pittsburgh, PA, and Kanti
Rai, MD, Long Island Jewish Medical Center,
New Hyde Park, NY.
Summary
Expert Opinion on Biological Therapy
March 2010, Vol. 10, No. 3, Pages 439-449 , DOI 10.1517/14712590903586239
Ofatumumab, a human anti-CD20 monoclonal antibody
Anders Österborg MD PhD Professor of Oncology
Submitted January 2, 2010; accepted March 5, 2010.
________________________________________Review Articles
Ofatumumab, a Novel Anti-CD20 Monoclonal Antibody for the Treatment of B-Cell Malignancies
Bruce D. Cheson
From Georgetown University Hospital, Washington, DC.
research paper april 2010
Pharmacokinetics and pharmacokinetic/pharmacodynamic associations of ofatumumab, a human monoclonal CD20 antibody, in patients with relapsed or refractory chronic lymphocytic leukaemia: a phase 1-2 study
Ofatumumab Combined With Fludarabine and Cyclophosphamide (O-FC) Shows High Activity in Patients With Previously Untreated Chronic Lymphocytic Leukemia: Results From a Randomized, Multicenter, International, Two-Dose, Parallel-Group Phase II Trial
Journal Clinical Lymphoma, Myeloma & Leukemia
Publisher CIG Media Group, L.P.
ISSN 2152-2650 (Print) 2152-2669 (Online)
Issue Volume 10, Number 3 / June 2010
J Clin Oncol. 2010 Apr 1;28(10):1749-55. Epub 2010 Mar 1.
Ofatumumab as single-agent CD20 immunotherapy in fludarabine-refractory chronic lymphocytic leukemia.
Wierda WG, Kipps TJ, Mayer J, Stilgenbauer S, Williams CD, Hellmann A, Robak T, Furman RR, Hillmen P, Trneny M, Dyer MJ, Padmanabhan S, Piotrowska M, Kozak T, Chan G, Davis R, Losic N, Wilms J, Russell CA, Osterborg A; Hx-CD20-406 Study Investigators.
The University of Texas M.D. Anderson Cancer Center, Houston, TX 77030-4009, USA. [email protected]
Clin Adv Hematol Oncol. 2010 Jan;8(1):28-30.
Advances in LLM. Ofatumumab: a new agent for chronic lymphocytic leukemia.
Osterborg A.
Karolinska University Hospital, Karolinska Institutet, SE-171 77 Stockholm, Sweden.
Cancer Chemotherapy Update - Ofatumumab and Romidepsin
Journal Hospital Pharmacy
Publisher Thomas Land Publishers Inc.
ISSN 0018-5787
Issue Volume 45, Number 5 / May 2010
Category Cancer Chemotherapy Update
News and Analysis
Nature Reviews Drug Discovery 9, 101-102 (February 2010) ' doi:10.1038/nrd3100
FRESH FROM THE PIPELINE:
Ofatumumab
Michael J. Keating1, Argyris Dritselis2, Uma Yasothan2 & Peter Kirkpatrick
J Castillo - Journal of Blood Medicine, 2010 - dovepress.com
Ofatumumab for fludarabine- and
alemtuzumab-refractory CLL
A novel anti-CD20 monoclonal antibody produces durable remissions in patients with refractory chronic
lymphocytic leukemia
Summary by Matt Stenger, MS; reviewed by
Dhaval Mehta, MD, University of Pittsburgh
Cancer Institute, Pittsburgh, PA, and Kanti
Rai, MD, Long Island Jewish Medical Center,
New Hyde Park, NY.
Summary
Expert Opinion on Biological Therapy
March 2010, Vol. 10, No. 3, Pages 439-449 , DOI 10.1517/14712590903586239
Ofatumumab, a human anti-CD20 monoclonal antibody
Anders Österborg MD PhD Professor of Oncology
Submitted January 2, 2010; accepted March 5, 2010.
________________________________________Review Articles
Ofatumumab, a Novel Anti-CD20 Monoclonal Antibody for the Treatment of B-Cell Malignancies
Bruce D. Cheson
From Georgetown University Hospital, Washington, DC.
research paper april 2010
Pharmacokinetics and pharmacokinetic/pharmacodynamic associations of ofatumumab, a human monoclonal CD20 antibody, in patients with relapsed or refractory chronic lymphocytic leukaemia: a phase 1-2 study
Og det er vel nøjagtig også det der skal til så onkologerne får øjnene op for stoffet. Måske måske er vi på vej mod lysere tider.
2/6 2010 20:39 gentogen 029905 Tilfældigt tidspunkt??
København, Danmark, 2. juni 2010 - Genmab A/S (OMX: GEN) offentliggjorde i dag,
at på et bestyrelsesmøde har bestyrelsen besluttet at tildele 337.500 warrants
(tegningsoptioner) til bestyrelsesmedlemmer, direktion og medarbejdere i
selskabet og selskabets datterselskaber.
København, Danmark, 2. juni 2010 - Genmab A/S (OMX: GEN) offentliggjorde i dag,
at på et bestyrelsesmøde har bestyrelsen besluttet at tildele 337.500 warrants
(tegningsoptioner) til bestyrelsesmedlemmer, direktion og medarbejdere i
selskabet og selskabets datterselskaber.
De har lige fået medarbejderrepræsentanter i bestyrelsen, så det kan hænge sammen med det.
5/6 2010 17:18 gentogen 029985 Fra ASCO:http://abstract.asco.org/AbstView_74_47330.html
Background: Zalutumumab is a novel, fully human IgG1 mAb targeting the EGFr that has shown encouraging activity in SCCHN. Methods: Patients with noncurable SCCHN with an ECOG PS of 0-2 and centrally documented radiographic progressive disease (PD) within 6 months after platinum-therapy were randomized between zalutumumab monotherapy and best supportive care (BSC) in a 2:1 ratio. Stratification parameter was ECOG PS. Methotrexate (MTX) was allowed in the BSC arm only. Individual dose-titration of zalutumumab was applied (max. exposure 16 mg/kg). The primary endpoint was overall survival (OS), with progression free survival (PFS) as the only secondary endpoint to be compared between groups, using log-rank test. 231 deaths were required to statistically differentiate OS between groups with 80% power. Results: 286 patients (34F, 252M) were randomized. The median age was 57 years (range 18-78), 65% had distant metastasis and 17% were ECOG PS 2, all similar between groups. 78% of patients in BSC arm received MTX. Although a median OS of 6.7 months was observed in the zalutumumab group compared to 5.2 in the BSC group, this was not statistically significant (p=0.065). A clear improvement in PFS (P=0.001) was demonstrated. Zalutumumab showed a safety profile as expected within this drug class. Conclusions: This is the first controlled study to demonstrate that an EGFr-targeted antibody given as monotherapy induces a clinically meaningful improvement in PFS in patients with SSCHN who have failed platinum-based chemotherapy.
Background: Zalutumumab is a novel, fully human IgG1 mAb targeting the EGFr that has shown encouraging activity in SCCHN. Methods: Patients with noncurable SCCHN with an ECOG PS of 0-2 and centrally documented radiographic progressive disease (PD) within 6 months after platinum-therapy were randomized between zalutumumab monotherapy and best supportive care (BSC) in a 2:1 ratio. Stratification parameter was ECOG PS. Methotrexate (MTX) was allowed in the BSC arm only. Individual dose-titration of zalutumumab was applied (max. exposure 16 mg/kg). The primary endpoint was overall survival (OS), with progression free survival (PFS) as the only secondary endpoint to be compared between groups, using log-rank test. 231 deaths were required to statistically differentiate OS between groups with 80% power. Results: 286 patients (34F, 252M) were randomized. The median age was 57 years (range 18-78), 65% had distant metastasis and 17% were ECOG PS 2, all similar between groups. 78% of patients in BSC arm received MTX. Although a median OS of 6.7 months was observed in the zalutumumab group compared to 5.2 in the BSC group, this was not statistically significant (p=0.065). A clear improvement in PFS (P=0.001) was demonstrated. Zalutumumab showed a safety profile as expected within this drug class. Conclusions: This is the first controlled study to demonstrate that an EGFr-targeted antibody given as monotherapy induces a clinically meaningful improvement in PFS in patients with SSCHN who have failed platinum-based chemotherapy.
5/6 2010 17:42 HRmunk 029986 Lyder det ikke som noget vi har hørt før? Og vel ikke særlig opmuntrende?
Jo - men vi forventede ikke mere.
Det der er interessant nu er hvorvidt FDA/EMEA finder stoffets resultater for gode nok til at file en BLA.
Det forhandler Genmab pt med nævnte myndigheder.
Er der tommelen op så kan der komme en aftale med nogle millioner dollers til Genmab.
Det der er interessant nu er hvorvidt FDA/EMEA finder stoffets resultater for gode nok til at file en BLA.
Det forhandler Genmab pt med nævnte myndigheder.
Er der tommelen op så kan der komme en aftale med nogle millioner dollers til Genmab.
5/6 2010 20:49 RTH 029995 Solsen - hvor mange mio. dollars vil der evt. blive tale om? vi har jo ikke statistisk signifikant primary endpoint men hvor meget er secondary endpoint egentlig værd her? er det i kombibehandlinger vi evt. skal se Zalu?
5/6 2010 18:07 gentogen 029989 Jo. Data i abstract er de velkendte fra marts (der er dog lidt flere data på linket). Som Aka forudså intet afgørende nyt, så det er vel ikke uventet.
I den forstand er det vel hverken opmuntrende eller det modsatte, da der umiddelbart ikke er noget nyt, men pointen er jo (fortsat), som de selv skriver, at dette er det første KONTROLLEREDE studie til at påvise dette omfang af effekt (30% OS)(61% PFS)-(hvilket selvfølgelig heller ikke er ny viden, men måske lidt undervurderet viden, - det er jo det store spørgsmål.....).
I den forstand er det vel hverken opmuntrende eller det modsatte, da der umiddelbart ikke er noget nyt, men pointen er jo (fortsat), som de selv skriver, at dette er det første KONTROLLEREDE studie til at påvise dette omfang af effekt (30% OS)(61% PFS)-(hvilket selvfølgelig heller ikke er ny viden, men måske lidt undervurderet viden, - det er jo det store spørgsmål.....).
7/6 2010 09:23 MadsK 030016 Den her passer da meget godt ind i tråden:
Genmab: Fyring af Lisa Drakeman vil give stor kursstigning
- Genmabs adm. direktør Lisa Drakeman er uden sammenligning den mest upopulære CEO blandt topcheferne på Københavns Fondsbørs. Af 15 aktieanalytikere og porteføljeforvaltere, der har vurderet kurseffekten af Lisa Drakemans eventuelle fratræden, mener samtlige, at det vil få aktien til at stige.
2/3-dele af dem mener oveni købet, at et exit for den administrerende direktør vil give en "stor kursstigning."
Resultatet fremgår af Økonomiske Ugebrevs Direktør- Rating, hvor vi har bedt 65 analytikere og porteføljeforvaltere vurdere kurseffekten af en eventuel direktørfratræden.
Resultaterne er ikke i alle tilfælde de samme, som i den almindelige DirektørRating, da kurseffekten i høj grad også vil afhænge af en række mere bløde parametre end selve ledelseskvaliteten. En kraftig kursstigning efter en fyring kan kun tolkes på den måde, at analytikere og investorer er grundigt trætte af den pågældende topchef, og at det stort set kun kan blive bedre med en ny mand på posten.
- For Genmabs vedkommende har der siden starten af 2009 været en næsten ubrudt nedtur i aktiekursen, der i perioden er dykket fra kurs 250 til kurs 48. Skuffende resultater fra kliniske forsøg, en dyrt indkøbt fabrik i USA, som måske ikke engang kan sælges efter en betydelig nedskrivning, og en meget udansk og nærmest uhæmmet tildeling af optioner til ledelsen og ledende medarbejdere gennem årene, har kostet store pointtab på image- og troværdighed til ledelsen med Lisa Drakeman i spidsen, skriver Økonomisk Ugebrev.
Genmab: Fyring af Lisa Drakeman vil give stor kursstigning
- Genmabs adm. direktør Lisa Drakeman er uden sammenligning den mest upopulære CEO blandt topcheferne på Københavns Fondsbørs. Af 15 aktieanalytikere og porteføljeforvaltere, der har vurderet kurseffekten af Lisa Drakemans eventuelle fratræden, mener samtlige, at det vil få aktien til at stige.
2/3-dele af dem mener oveni købet, at et exit for den administrerende direktør vil give en "stor kursstigning."
Resultatet fremgår af Økonomiske Ugebrevs Direktør- Rating, hvor vi har bedt 65 analytikere og porteføljeforvaltere vurdere kurseffekten af en eventuel direktørfratræden.
Resultaterne er ikke i alle tilfælde de samme, som i den almindelige DirektørRating, da kurseffekten i høj grad også vil afhænge af en række mere bløde parametre end selve ledelseskvaliteten. En kraftig kursstigning efter en fyring kan kun tolkes på den måde, at analytikere og investorer er grundigt trætte af den pågældende topchef, og at det stort set kun kan blive bedre med en ny mand på posten.
- For Genmabs vedkommende har der siden starten af 2009 været en næsten ubrudt nedtur i aktiekursen, der i perioden er dykket fra kurs 250 til kurs 48. Skuffende resultater fra kliniske forsøg, en dyrt indkøbt fabrik i USA, som måske ikke engang kan sælges efter en betydelig nedskrivning, og en meget udansk og nærmest uhæmmet tildeling af optioner til ledelsen og ledende medarbejdere gennem årene, har kostet store pointtab på image- og troværdighed til ledelsen med Lisa Drakeman i spidsen, skriver Økonomisk Ugebrev.
