AI
Wednesday, May 03, 2023 1:05:04 AM
georgebailey, I do not know if poly-ICLC was used as the maturation and activation agent in the completed DCVax-L Phase III trial. That information was not disclosed in the JAMA Oncology peer-reviewed article.
There was some information disclosed in the 2018 interim study release about the ITT blended and blinded results, but it did not provide much details:
As you may know, the exact details about how to make a DCVax-L vaccine are proprietary and patented. But, there are pre-defined processes that are required to make DCVax-L: (1) use the patient’s own tumor / cells / blood to make the vaccine, (2) separate the patient’s dendritic cells, (3) add a maturation agent (there are several to choose from, (4) add an activation agent (there are several to choose from), (5) inject the vaccine back into the patient.
However, my guess is that if poly-ICLC was used, it was not used on very many patients because I believe if poly-ICLC had been used for most or all of the trial patients, the OS would have been higher than 19.3 months, and the 5-Year survival rate would be higher than 13%. Maybe even a 50% or higher 5-Year+ survival rate, based on the interim Phase II results.
As you may know, the last patient in the DCVax-L Phase III trial was dosed in 2015 I believe. The DCVax-L + poly-ICLC Phase I/II trial started around 2010. UCLA and NWBio learned after the DCVax-L Phase III started in 2007, that the best and most efficacious maturation and activation agent is poly-ICLC.
The DCVax-L patented processes allow NWBio to use the best and most efficacious maturation and activation agents. GBM patients should not die unnecessarily or prematurely because some do not want NWBio to use a safe and the most efficacious maturation and activation agents.
There was some information disclosed in the 2018 interim study release about the ITT blended and blinded results, but it did not provide much details:
As you may know, the exact details about how to make a DCVax-L vaccine are proprietary and patented. But, there are pre-defined processes that are required to make DCVax-L: (1) use the patient’s own tumor / cells / blood to make the vaccine, (2) separate the patient’s dendritic cells, (3) add a maturation agent (there are several to choose from, (4) add an activation agent (there are several to choose from), (5) inject the vaccine back into the patient.
However, my guess is that if poly-ICLC was used, it was not used on very many patients because I believe if poly-ICLC had been used for most or all of the trial patients, the OS would have been higher than 19.3 months, and the 5-Year survival rate would be higher than 13%. Maybe even a 50% or higher 5-Year+ survival rate, based on the interim Phase II results.
As you may know, the last patient in the DCVax-L Phase III trial was dosed in 2015 I believe. The DCVax-L + poly-ICLC Phase I/II trial started around 2010. UCLA and NWBio learned after the DCVax-L Phase III started in 2007, that the best and most efficacious maturation and activation agent is poly-ICLC.
The DCVax-L patented processes allow NWBio to use the best and most efficacious maturation and activation agents. GBM patients should not die unnecessarily or prematurely because some do not want NWBio to use a safe and the most efficacious maturation and activation agents.
Bullish
