"Progression Free Survival"
Did others notice the secondary objective called “progression free survival” in today's PR. This is different from Median Time To Progression (MTTP) and would seem to allow the Company to announce efficacy results much sooner. Here’s why:
MTTP requires that you monitor all patients in the study for about six months after dosing to determine the average time it took for the tumors to progress. In the prior Cotara study the MTTP for patients treated with sweet-spot dosing was 20 weeks or around 5 months (which compared very favorably to 9 weeks or 2 months for SOC)
We know that under SOC half the tumors enlarge by about 30% after 2 months. MRI scans done of Cotara-treated tumors 2 months after dosing typically show a tumor that is the same size or only slightly smaller than before dosing. Over the next few months the Cotara-treated tumor will shrink or disappear, but after just two months doctors know Cotara is working because tumor size is stable as compared with SOC-treated tumors that show a 30% progression after two months.
In the current study they will look at “progression free survival,” which would seem to mean that they look at the surviving pool of patients 2 months after dosing and again 3, 4 and 5 months after dosing and ask, “How many of these patients are progression free as compared with SOC?”
Bottom Line: If twenty patients are dosed with Cotara during August at 3-4 clinical sites, then two months later in early November we hope/expect the Company will publish interim results reporting something like this: “As compared with SOC where 50% of tumors have progressed by more than 30% after two months, only 10% -20% (??) of Cotara-treated tumors have progressed after two months.
Three months later in early December we hope/expect the Company will publish interim results reporting something like this: “As compared with SOC where 70% of tumors have progressed by more than 30% after three months, only 10% -20% (??) of Cotarata-treated tumors have progressed after three months.
Four months later in early January we hope/expect the Company will publish interim results reporting something like this: “As compared with SOC where 90% of tumors have progressed by more than 30% after four months, only 10% -20% (??) of Cotarata-treated tumors have progressed after four months and xx% of those tumors have shown remission greater than 30%.
Six months later in March we hope/expect the Company will publish interim results reporting something like this: “As compared with SOC where 50% of patients are dead after six months, 90%-100% (??) of Cotara-treated patients are still living after six months.
My bet is that BP will only need to see the November data to know Cotara is the new SOC for GBM and get real serious about re-starting license/partnership negotiations. The deal will probably close and be announced around Jan '08 after BP has seen two more months of confirming data.
