"It can be pointed out that the last patient in the CUP-trial of Belinostat was enrolled in December 2010. The first was recruited in April 2009. 33 were reported as recruited in january 2010. A total of 89 patient were recruited. Endpoint is when 68 patients have left PFS, i.e. when their cancer shows progression. The controll-arm with the first-line treatment CaP normally have a medium PFS at 5-6 months - a record in one trial reaches almost 6.5. The rest is pure math. It shows that the BelCaP-arm is on its way to become something spectacular. Topotarget and SPPI first expected the trial to be finnished last summer, or actually before the end of H1 2011. The patients however refuses to leav PFS, and statistics shows that these patients can not possibly be those in the CaP-arm. Consequently they must be in the BelCaP-arm. There is indeed sensational things happening here."
http://medicoinvestor.com/about-spectrum-pharmaceuticals-inc.html?utm_source=rss&utm_medium=rss&utm_campaign=about-spectrum-pharmaceuticals-inc
http://medicoinvestor.com/about-spectrum-pharmaceuticals-inc.html?utm_source=rss&utm_medium=rss&utm_campaign=about-spectrum-pharmaceuticals-inc
15/2 2012 15:07 Gorm 0
53065 Låt mig påminna om nedanstående artikel, framförallt figur 3, s. 47. Grafen visar att det det efter 11 månader är 6% kvar med PFS i CaP-armen, dvs 44*0.06 = 2-3 st kvar - om man räknar endast från det att rekryteringen avslutades i december 2010! Rimligen återstår absolut max 5 patienter från denna arm. Idag torde max 1 patient vara kvar i PFS i CaP-armen, och högst 5 patienter är över huvud kvar i livet. Förklaringen till att vi inte nått PD för 68 patienter MÅSTE således vara att BelCaP presterar MYCKET bättre än väntat och framförallt mycket bättre än CaP.
http://www.nature.com/bjc/journal/v100/n1/pdf/6604818a.pdf
http://www.nature.com/bjc/journal/v100/n1/pdf/6604818a.pdf
16/2 2012 11:37 Gorm 053097 "Patients with CUP represent a diverse group, but in the majority of patients, empiric chemotherapy is the treatment of choice. At present, the combination of carboplatin and paclitaxel is a common choice for first-line therapy. This regimen produces a response rate of 25-40%, median progression-free survival of 4-6 months, overall survival of 9-11 months, and a 2-year survival of approximately 20%."
This caused TOPOTARGET, at the completion of enrolment in December 2010, to estimate that they would be able to present top-line data in Q3 2011.
"Top-line results of progression-free survival and response rate are expected by Q3 2011. Final evaluation of overall survival is expected in Q1 2012."
Both quotes from:
http://investor.topotarget.com/releasedetail.cfm?releaseid=538667
However, today TOPOTAGET estimates that top-line data will be expected in the early Q2 2012! See the trigger-list at page 21 in this presentation from a few days ago:
http://investor.topotarget.com/common/download/download.cfm?companyid=ABEA-4C7P7T&fileid=540991&filekey=5d379954-ad00-4ce8-b4d6-6bffe6ae48e0&filename=Corporate%20Presentation_Swiss-Scandinavian%20Bio-Business%202012.pdf
The reason for the delay: The patients stays in PFS!
This is indeed astonishing! Confer for instance figure nr 3 at page 47 in this article concerning the effects of CaP in CUP:
http://www.nature.com/bjc/journal/v100/n1/pdf/6604818a.pdf
It is high time to buy TOPOTARGET!
This caused TOPOTARGET, at the completion of enrolment in December 2010, to estimate that they would be able to present top-line data in Q3 2011.
"Top-line results of progression-free survival and response rate are expected by Q3 2011. Final evaluation of overall survival is expected in Q1 2012."
Both quotes from:
http://investor.topotarget.com/releasedetail.cfm?releaseid=538667
However, today TOPOTAGET estimates that top-line data will be expected in the early Q2 2012! See the trigger-list at page 21 in this presentation from a few days ago:
http://investor.topotarget.com/common/download/download.cfm?companyid=ABEA-4C7P7T&fileid=540991&filekey=5d379954-ad00-4ce8-b4d6-6bffe6ae48e0&filename=Corporate%20Presentation_Swiss-Scandinavian%20Bio-Business%202012.pdf
The reason for the delay: The patients stays in PFS!
This is indeed astonishing! Confer for instance figure nr 3 at page 47 in this article concerning the effects of CaP in CUP:
http://www.nature.com/bjc/journal/v100/n1/pdf/6604818a.pdf
It is high time to buy TOPOTARGET!
The cause for this trial can be found here:
"Treatment options for patients with cancer of unknown primary (CUP) are limited; carboplatin and paclitaxel combination being one of the options. Belinostat, is a hydroxamate, class I and II histone deacetylase inhibitor (HDACi) with a broad antineoplastic activity. Phase I and II trials are ongoing in multiple indications and in more than 500 patients the most common adverse events have been nausea, vomiting and fatigue. Preclinical data shows synergistic effect when combined with carboplatin and paclitaxel in vitro and in vivo. In a Phase I study for patients with pretreated advanced solid tumors, BelCaP was well-tolerated and active with objective responses seen in pancreatic and rectal cancer patients. A patient with CUP (3 prior chemotherapy regimens) had disease control during 29 months of treatment. Therefore, we are conducting a randomized Phase 2 study (N~88) of CaP with or without belinostat in CUP patients."
http://www.evaluatepharma.com/Universal/View.aspx?type=Story&id=214481
Disease control during 29 months of treatment after three failed chemotherapy regimens. Was this a coincidence? It seems not.
Today its about 34 months since the Phase II trial started to recruit, and 14 since it was fully enrolled.
TOPOTARGET: strong buy!
"Treatment options for patients with cancer of unknown primary (CUP) are limited; carboplatin and paclitaxel combination being one of the options. Belinostat, is a hydroxamate, class I and II histone deacetylase inhibitor (HDACi) with a broad antineoplastic activity. Phase I and II trials are ongoing in multiple indications and in more than 500 patients the most common adverse events have been nausea, vomiting and fatigue. Preclinical data shows synergistic effect when combined with carboplatin and paclitaxel in vitro and in vivo. In a Phase I study for patients with pretreated advanced solid tumors, BelCaP was well-tolerated and active with objective responses seen in pancreatic and rectal cancer patients. A patient with CUP (3 prior chemotherapy regimens) had disease control during 29 months of treatment. Therefore, we are conducting a randomized Phase 2 study (N~88) of CaP with or without belinostat in CUP patients."
http://www.evaluatepharma.com/Universal/View.aspx?type=Story&id=214481
Disease control during 29 months of treatment after three failed chemotherapy regimens. Was this a coincidence? It seems not.
Today its about 34 months since the Phase II trial started to recruit, and 14 since it was fully enrolled.
TOPOTARGET: strong buy!
16/2 2012 14:43 Gorm 053118 As a complementary guidance page 31 in the following presentation can be consulted:
http://files.shareholder.com/downloads/ABEA-4C7P7T/1700413671x0x456913/ae753c4e-54a4-4120-84a0-67fb2f81c640/DK%20retail%20investor%2004042011.pdf
http://files.shareholder.com/downloads/ABEA-4C7P7T/1700413671x0x456913/ae753c4e-54a4-4120-84a0-67fb2f81c640/DK%20retail%20investor%2004042011.pdf
