Wino115 wrote:
Agree, and PLEASE ask these important questions on the call. You must log in to the webcast to ask questions nd not the phone in number. We had a hint that recruitment was going well and they look to expand the trial size, likely to increase probabilities given the focus solely on refractory end stage at this point. Both are positive signals.
On efficacy, let's not forget what our friend said a while back, with one cycle the doctors saw the CA125 protein marker fall over 30% and he had not seen that in any previous other drug treatments. Cancer Antigen 125 is highly useful for endothelial ovarian cancer. It is highly indicative of whether the cancer is responding to the drug or not. Here is from a pathology hand book:
"If CA-125 levels fall during therapy, this generally indicates that the cancer is responding to treatment. If CA-125 levels rise, the cancer may not be responding to treatment. High CA-125 levels after treatment is complete may indicate that the cancer has come back"
That hint we heard is very, very positive. The cancer was responding to the drug after one cycle. Put another way, if the toxin was not getting in to the tumor, it would not have fallen over 30%. It would have been the same or likely risen. The fact the most widely measured cancer marker from blood fell a statistically huge amount is very meaningful as far as the concept seeming to work, and ultimately the drug having a good shot at efficacy over multiple cycles and longer treatments. Obviously there are still risks around accumulation and safety which we will learn, and the level of sort1 expression needed for response. Other drugs have response rates in the 30-40% level so that is the mark. We shouldn't expect much different and be pleasantly surprised if it is higher in certain cancers. Although, to be statistically significant for each tumor type you need the P2 type enrollment numbers and not the small 10-20 type numbers in this conceptual proof phase.
So that may be the most important finding we have quantified thus far and it's an actual blood test reading of a clear cancer response signal from one cycle.
PLEASE ASK GOOD MEANINGFUL QUESTIONS TO GET GOOD ANSWERS. I am looking forward to hearing the call and hearing all your questions. I will also be putting through some fair and incisive questions and I know others will be.
palinc2000 wrote: The plan is to recruit 10 patients per tumor type .While I will be surprised if they reveal much clinical data I hope they disclose the number of patients per tumor type recruited so far and their best estimate of the pace of enrollment going forward...
The plan also includes a goal of 15 patients in a different mix of tumors,,,I also expect an upgate pn the number of patients so far...