Från Arafat på grannkanalen:
"Godmorgen.
Nu skal jeg ikke bombardere jer med et nyt indlæg hver morgen,jeg fik desværre slet ikke tid til at medvirke i debatten i går.
Men Rajesh, af en eller anden grund forærede os resultaterne til PTCL studiet sidste uge,ikke detaljeret resultater.
Men vi ved den sidste patient blev rekrutteret slutningen af september i år, og at en behandling med belinostat varer i 3 uger,og jeg mener man minimum skal have have 2 behandlinger af belinostat,for at medvirke i studiet.
Og vi ved også, at hvis man efter den anden behandling med belinostat , ikke har oplevet effekt,ved at man enten har standset kræften,ved enten at stabilisere kræften, eller den er begyndt at skrumpe,så standser man desværre behandlingen med belinostat.
Men at CEO for SPPI, går ud og siger 3 måneder efter sidste patient er rekrutteret,at 18-19 patienter stadig er i behandling,og selv mener det er et godt tegn,er det samme som at sige,vi har 18-19 patienter som minimum har fået 3 behandlinger med belinostat,og belinostat enten har stabiliseret eller mindsket tumoren på de 18-19 patienter.
Det er den rene foræring fra Rajesh. :)"
"Godmorgen.
Nu skal jeg ikke bombardere jer med et nyt indlæg hver morgen,jeg fik desværre slet ikke tid til at medvirke i debatten i går.
Men Rajesh, af en eller anden grund forærede os resultaterne til PTCL studiet sidste uge,ikke detaljeret resultater.
Men vi ved den sidste patient blev rekrutteret slutningen af september i år, og at en behandling med belinostat varer i 3 uger,og jeg mener man minimum skal have have 2 behandlinger af belinostat,for at medvirke i studiet.
Og vi ved også, at hvis man efter den anden behandling med belinostat , ikke har oplevet effekt,ved at man enten har standset kræften,ved enten at stabilisere kræften, eller den er begyndt at skrumpe,så standser man desværre behandlingen med belinostat.
Men at CEO for SPPI, går ud og siger 3 måneder efter sidste patient er rekrutteret,at 18-19 patienter stadig er i behandling,og selv mener det er et godt tegn,er det samme som at sige,vi har 18-19 patienter som minimum har fået 3 behandlinger med belinostat,og belinostat enten har stabiliseret eller mindsket tumoren på de 18-19 patienter.
Det er den rene foræring fra Rajesh. :)"
20/12 2011 10:34 Gorm 0
50156 TOPO är idag inte längre värt några hundra miljoner DKK. Det är värt miljarder!
20/12 2011 12:24 Gorm 050160 Astra gör en avskrivning värd 2000 miljoner sek för ett misslyckat fas2 försök mot äggstockscanser.
Hela topotarget värderas idag till 400 miljoner sek.
De har osynad CUP fas2 med betydande chans för att visa bra resultat.
De har pågående fas2 för NsClc
Detta är blockbuster indikationer.
De har PTCL enligt mig med 90% chans att nå endpoints. Denna är i fas3.
Vad hade astra värderat belinostat till i deras bokföring om de ägt det?
10 ggr dagens värde som aktiemarknaden värderar topo, det är min gissning.
Hela topotarget värderas idag till 400 miljoner sek.
De har osynad CUP fas2 med betydande chans för att visa bra resultat.
De har pågående fas2 för NsClc
Detta är blockbuster indikationer.
De har PTCL enligt mig med 90% chans att nå endpoints. Denna är i fas3.
Vad hade astra värderat belinostat till i deras bokföring om de ägt det?
10 ggr dagens värde som aktiemarknaden värderar topo, det är min gissning.
20/12 2011 14:38 På slap line 050163 Hvornår forventer du den kurs: 26.
Såfremt alle data bare køre i olie, ja så er det ikke umuligt, men det kan stadig gå galt.
PS: Ja jeg er TopoTarget investor.
Såfremt alle data bare køre i olie, ja så er det ikke umuligt, men det kan stadig gå galt.
PS: Ja jeg er TopoTarget investor.
20/12 2011 16:22 troldmanden 050166 "Og vi ved også, at hvis man efter den anden behandling med belinostat , ikke har oplevet effekt,ved at man enten har standset kræften,ved enten at stabilisere kræften, eller den er begyndt at skrumpe,så standser man desværre behandlingen med belinostat."
Det er fint nok. Men hvad nu hvis "placebo" gruppen oplever det samme? Præcis som vi så med Genmabs fase 3 forsøg.
Udfra det indlæg så virker det slet ikke til at være noget Arafat skænker en tanke.
Er det positivt at de lever længere? Ja.
Øges sandsynligheden for et godt resultat? ja
Er det så sikkert det opnår et godt resultat? Nej
Det er fint nok. Men hvad nu hvis "placebo" gruppen oplever det samme? Præcis som vi så med Genmabs fase 3 forsøg.
Udfra det indlæg så virker det slet ikke til at være noget Arafat skænker en tanke.
Er det positivt at de lever længere? Ja.
Øges sandsynligheden for et godt resultat? ja
Er det så sikkert det opnår et godt resultat? Nej
20/12 2011 21:55 ToxicAss 050183 hvordan når du frem til, at PTCL har 90 % chance til endpoint? Det er urealistisk!
topo er meget spændende, men chancen for en givende succes er slet ikke oppe i nærheden
af 90 %
jeg har selv topo, men begynder at tvivle mere og mere
topo er meget spændende, men chancen for en givende succes er slet ikke oppe i nærheden
af 90 %
jeg har selv topo, men begynder at tvivle mere og mere
20/12 2011 23:13 troldmanden 050192 Enig. Det er trods alt alt for højt. Normalt så siger man at der er ca 50% sandsynlighed for godkendelse når fase 3 indledes. Og SÅ meget stiger sandsynligheden altså ikke blot fordi der går længere tid end "planlagt" inden patienterne dør. Det sker som tidligere nævnt også fra tid til anden at "placebo" patienterne levre længere.
Det er svært at sætte procent på. Men il nok sætte den til omkring 60% på nuværende tidspunkt.
Det er svært at sætte procent på. Men il nok sætte den til omkring 60% på nuværende tidspunkt.
21/12 2011 09:28 Gorm 050199 troldmanden, nu bygger ju uppskattningen ifråga på helt annan information än den du utgår ifrån, framför allt en analys DMC's beslut i Mars, nu konfirmerat med Rajesh besked om 18-19 patienter och att "that is a good sign".
Det är CUP-studien som skapat god prognos för extremt bra resultat genom att dra ut på tiden, se:
http://www.redeye.se/aktiebloggen/topotarget/68-%E2%80%93-important-number-topotarget-investor
Det är CUP-studien som skapat god prognos för extremt bra resultat genom att dra ut på tiden, se:
http://www.redeye.se/aktiebloggen/topotarget/68-%E2%80%93-important-number-topotarget-investor
21/12 2011 09:34 Gorm 050200 Klipp om CUP-studien:
"ON BELINOSTAT IN CUP - sensational statistics
Before ASCO 2010 TOPOTARGET announced that "33 pts have been randomized as of 6 Jan 2009 " (note 1). It has been made clear that this was a printing error for '6 Jan 2010', since the study started in February 2010 (note 2). The recruitment of patients seems consequently to have been very even over time, since all the 88 (89) patients were recruited in December 2010. 88 patients/22 months gives 4 recruited patients per month.
At TOPO's latest telephone-conference it was made public that 68 'events' was needed to complete the CUP-trial, i.e. 68 patients had to be taken out of the trial because t6hey were no longer to be in PFS (progression-free survival) but had entered PD (progressive disease). This means that att least 20 patients in the trial are still in PFS. This explains why the trial have been postponed for so long, but actually also reveals some sensational circumstances.
We know that in February 2010 about half of the required patients had been recruited, i.e. 44 patients. Let's say that by the beginning of March 2010 at least 40 patients had been recruited. Median survival with CaP is 13 months, which means that by April 2011 20 patients would have already died [if the results followed the CaP-standard. A tentative estimation consequently gives at hand that 68 patients would have suspected to have reached PD a long time ago now, and that was also what TOPOTARGET and SPPI had expected when they started the trial, yes in fact still when they closed down the recruitment in December 2010. By then they announced that the top line results were expected in early Q3 2011. But the CUP-patients in this trial remain in PFS.
If we look more in detail of Cap's well examined effect in CUP, we find some very surprising figures. As said, still 12 months after closed recruitment we still find at least 20 patients in PFS. Previous studies have clearly shown that from a statistical point of view only one or two patients in the CaP-arm of the trial would be suspected to still remain in PFS. See for example (note 3, figure 3, p. 47). This figure shows that after 11 months only 6% of the CaP-arm could be suspected to still remain in PFS, i.e. 44x0.06 = 2-3 patients, counted only as if all patients had been recruited in December 2010! On the basis of all the very good statistics available for CaP in CUP we can safely say that no more than absolutely maximum 5 patients of the CaP-arm could possible remain in PFS. The explanation that we PD has not been reached for 68 patients yet MUST consequently be that the BelCaP-arm is doing MUCH better than expected, and most of all MUCH better than the CaP-arm.
Another way to express the matter is that about 25% of the patients still remain in PFS, apposed to an expected figure that according to all available statistics for CaP in CUP would consist of only some solitary percentage.
See also (note 4 and 5).
TOPOTARGET seems accordingly to have something extremely big comming! A closer look at the statistics makes this totally evident. According to CaP's track-reckord 25% would hardly be alive at all.
TOPOTARGETS market cap is today ca $46 MUSD.
The deal with SPPI about US and India on these markets is worth $350 MUSD and a double digit royalty, of which only $30 MUSD have yet been paid."
note 1
http://www.asco.org/ascov2/Meetings/Abstracts?&vmview=abst_detail_view&confID=74&abstractID=49005
note 2
http://clinicaltrials.gov/ct2/show/NCT00894569
note 3
http://www.nature.com/bjc/journal/v100/n1/pdf/6604818a.pdf
note 4
http://www.redeye.se/aktiebloggen/topotarget/68-%E2%80%93-important-number-topotarget-investor
note 5
http://www.redeye.se/aktiebloggen/topotarget/topotarget-cup-studier-av-anndra-vs-belinostat
"ON BELINOSTAT IN CUP - sensational statistics
Before ASCO 2010 TOPOTARGET announced that "33 pts have been randomized as of 6 Jan 2009 " (note 1). It has been made clear that this was a printing error for '6 Jan 2010', since the study started in February 2010 (note 2). The recruitment of patients seems consequently to have been very even over time, since all the 88 (89) patients were recruited in December 2010. 88 patients/22 months gives 4 recruited patients per month.
At TOPO's latest telephone-conference it was made public that 68 'events' was needed to complete the CUP-trial, i.e. 68 patients had to be taken out of the trial because t6hey were no longer to be in PFS (progression-free survival) but had entered PD (progressive disease). This means that att least 20 patients in the trial are still in PFS. This explains why the trial have been postponed for so long, but actually also reveals some sensational circumstances.
We know that in February 2010 about half of the required patients had been recruited, i.e. 44 patients. Let's say that by the beginning of March 2010 at least 40 patients had been recruited. Median survival with CaP is 13 months, which means that by April 2011 20 patients would have already died [if the results followed the CaP-standard. A tentative estimation consequently gives at hand that 68 patients would have suspected to have reached PD a long time ago now, and that was also what TOPOTARGET and SPPI had expected when they started the trial, yes in fact still when they closed down the recruitment in December 2010. By then they announced that the top line results were expected in early Q3 2011. But the CUP-patients in this trial remain in PFS.
If we look more in detail of Cap's well examined effect in CUP, we find some very surprising figures. As said, still 12 months after closed recruitment we still find at least 20 patients in PFS. Previous studies have clearly shown that from a statistical point of view only one or two patients in the CaP-arm of the trial would be suspected to still remain in PFS. See for example (note 3, figure 3, p. 47). This figure shows that after 11 months only 6% of the CaP-arm could be suspected to still remain in PFS, i.e. 44x0.06 = 2-3 patients, counted only as if all patients had been recruited in December 2010! On the basis of all the very good statistics available for CaP in CUP we can safely say that no more than absolutely maximum 5 patients of the CaP-arm could possible remain in PFS. The explanation that we PD has not been reached for 68 patients yet MUST consequently be that the BelCaP-arm is doing MUCH better than expected, and most of all MUCH better than the CaP-arm.
Another way to express the matter is that about 25% of the patients still remain in PFS, apposed to an expected figure that according to all available statistics for CaP in CUP would consist of only some solitary percentage.
See also (note 4 and 5).
TOPOTARGET seems accordingly to have something extremely big comming! A closer look at the statistics makes this totally evident. According to CaP's track-reckord 25% would hardly be alive at all.
TOPOTARGETS market cap is today ca $46 MUSD.
The deal with SPPI about US and India on these markets is worth $350 MUSD and a double digit royalty, of which only $30 MUSD have yet been paid."
note 1
http://www.asco.org/ascov2/Meetings/Abstracts?&vmview=abst_detail_view&confID=74&abstractID=49005
note 2
http://clinicaltrials.gov/ct2/show/NCT00894569
note 3
http://www.nature.com/bjc/journal/v100/n1/pdf/6604818a.pdf
note 4
http://www.redeye.se/aktiebloggen/topotarget/68-%E2%80%93-important-number-topotarget-investor
note 5
http://www.redeye.se/aktiebloggen/topotarget/topotarget-cup-studier-av-anndra-vs-belinostat
21/12 2011 10:09 Gorm 050202 Nya studier!
Skribenten Nära på DI' Börssnack postade nu på morgonen detta.
'Någon som har tillgång till tidskriften "Immunology and Cell Biology"? Här kommer lite kul läsning i så fall. Det har nämligen kommit inte mindre än fyra artiklar senaste månaden som tar upp belinostat:
29 November 2011
HDAC inhibitors in cancer biology: emerging mechanisms and clinical applications
Omar Khan &
Nicholas B La Thangue
Immunology and Cell Biology doi:10.1038/icb.2011.100
22 November 2011
Modulation of antigen-presenting cells by HDAC inhibitors: implications in autoimmunity and cancer
Karrune V Woan,
Eva Sahakian,
Eduardo M Sotomayor,
Edward Seto &
Alejandro Villagra
Immunology and Cell Biology doi:10.1038/icb.2011.96
15 November 2011
HDAC inhibitors in HIV
Fiona Wightman,
Paula Ellenberg,
Melissa Churchill &
Sharon R Lewin
Immunology and Cell Biology doi:10.1038/icb.2011.95
15 November 2011
HDACi: molecular mechanisms and therapeutic implications in the innate immune system
Bandar Ali Suliman,
Dakang Xu &
Bryan RG Williams
Immunology and Cell Biology doi:10.1038/icb.2011.92
http://www.nature.com/search/executeSearch?sp
-q-1=ICB&sp-q=belinostat&sp-c=25&
sp-m=0&sp-s=date_descending&sp-a=sp10
01702d&sp-sfvl-field=subject'ujournal&
;sp-x-1=ujournal&sp-p-1=phrase&sp-p=a
ll&submit=go
I den första av dessa läser man tydligen bl.a.:
"The activity of the HDACi belinostat (PXD101) was investigated in three HCC cell lines. PXD101 was found to inhibit cell growth in a dose-dependent manner and induce histone acetylation in PLC/PRF/5, Hep3B and HepG2 cells. In PLC/PRF/5 and Hep3B cells that express hepatitis B-related genes (HBx and HBc), treatment with PXD101 provided apoptosis induction without a significant effect on viral gene expression."'
Skribenten Nära på DI' Börssnack postade nu på morgonen detta.
'Någon som har tillgång till tidskriften "Immunology and Cell Biology"? Här kommer lite kul läsning i så fall. Det har nämligen kommit inte mindre än fyra artiklar senaste månaden som tar upp belinostat:
29 November 2011
HDAC inhibitors in cancer biology: emerging mechanisms and clinical applications
Omar Khan &
Nicholas B La Thangue
Immunology and Cell Biology doi:10.1038/icb.2011.100
22 November 2011
Modulation of antigen-presenting cells by HDAC inhibitors: implications in autoimmunity and cancer
Karrune V Woan,
Eva Sahakian,
Eduardo M Sotomayor,
Edward Seto &
Alejandro Villagra
Immunology and Cell Biology doi:10.1038/icb.2011.96
15 November 2011
HDAC inhibitors in HIV
Fiona Wightman,
Paula Ellenberg,
Melissa Churchill &
Sharon R Lewin
Immunology and Cell Biology doi:10.1038/icb.2011.95
15 November 2011
HDACi: molecular mechanisms and therapeutic implications in the innate immune system
Bandar Ali Suliman,
Dakang Xu &
Bryan RG Williams
Immunology and Cell Biology doi:10.1038/icb.2011.92
http://www.nature.com/search/executeSearch?sp
-q-1=ICB&sp-q=belinostat&sp-c=25&
sp-m=0&sp-s=date_descending&sp-a=sp10
01702d&sp-sfvl-field=subject'ujournal&
;sp-x-1=ujournal&sp-p-1=phrase&sp-p=a
ll&submit=go
I den första av dessa läser man tydligen bl.a.:
"The activity of the HDACi belinostat (PXD101) was investigated in three HCC cell lines. PXD101 was found to inhibit cell growth in a dose-dependent manner and induce histone acetylation in PLC/PRF/5, Hep3B and HepG2 cells. In PLC/PRF/5 and Hep3B cells that express hepatitis B-related genes (HBx and HBc), treatment with PXD101 provided apoptosis induction without a significant effect on viral gene expression."'
21/12 2011 12:44 polopolo 050213 Til Gorm! Et gammelt dansk udtryk lyder Således :"Skru lidt ned for Charmen"
Til dig vil jeg sige :" Vær SØD at skrue lidt ned for hypen, den skærer i ørene" . Ellers- god jul.
Til dig vil jeg sige :" Vær SØD at skrue lidt ned for hypen, den skærer i ørene" . Ellers- god jul.
21/12 2011 12:55 troldmanden 050214 Gorm et hav af cancer stoffer får ok af DMC til at gåp videre uden de efterfølgende bliver godkendt. DMC kigger blot overordnet på om der er nogle alvorlige bivirkninger eller om dem på den aktive dosis ligefrem lever kortere end "placebo" armen. Det siger intet om der er stor nok forskel mellem de 2 arme til at opnå signifikans.
Jeg tør godt sige at du ikke kan finde én eneste uafhængig forsker der på nuværende tidspunkt regner med 90% sandsynlighed for belinostat. Og jeg er faktisk også ret sikker på at hvis man spurgte topotarget om de ser 90% sandsynlighed så vil de også sige at usikkerheden trods alt er større end det.
Jeg tør godt sige at du ikke kan finde én eneste uafhængig forsker der på nuværende tidspunkt regner med 90% sandsynlighed for belinostat. Og jeg er faktisk også ret sikker på at hvis man spurgte topotarget om de ser 90% sandsynlighed så vil de også sige at usikkerheden trods alt er større end det.
21/12 2011 14:24 Gorm 050221 troldmanden, du missar som oftast detaljerna. Det fanns kriterier i DMC's OK som i sig själva förutsatte resultat för PTCL-studien som kom mycket nära målen.Jag orkar dock inte redovisa dem här igen.
Och vad betyder väl detaljer.
Och vad betyder väl detaljer.
21/12 2011 14:45 troldmanden 050223 Du misser vel også lige en væsentlig detalje. At du ikke får nogen uafhængig forsker til at sige der er 90% sandsynlighed for succes med de forliggende informationer.
21/12 2011 15:20 Gorm 050228 OK troldmand, vi ger oss där tror jag. 90% var inget matematiskt tal utan snarare ett semantiskt uttryck för att indicierna nu starkt talar för att målen kommer att kunna nås.
21/12 2011 17:54 troldmanden 050240 Fint indlæg. Han gør også opmærksom på risikoen ved forsøgene fejler
