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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).
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
Sendt fra ProInvestor gruppen
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).
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
Sendt fra ProInvestor gruppen
26/11 2011 19:27 benny 0
49158 Har startet med at give et point for, at du trods alt "gidder" 
. Jeg "gider" ikke læse fagartikler på hverken svensk eller engelsk. Mest fordi jeg kan begge til husbehov, alm konversation, skønlitt. etc og frygter at mistolke eller misse marginalerne. Såhh deeettt.
. Jeg "gider" ikke læse fagartikler på hverken svensk eller engelsk. Mest fordi jeg kan begge til husbehov, alm konversation, skønlitt. etc og frygter at mistolke eller misse marginalerne. Såhh deeettt.