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Tuesday, 08/25/2015 11:53:43 PM

Tuesday, August 25, 2015 11:53:43 PM

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I have been reading back over prior press releases and website info trying to find data about other tumors and Kevetrin. I was surprised to find in the 9/24/14 update PR that Kevetrin in early cohorts stabilized the CA 125 in some ovarian CA pts and stabilized the CEA in one pancreatic CA pt(NB usual pancreatic ca marker is CA-19-9)for 4 months. This was news to me, since there has been no info on CA 125 or CA 19-9 or CEA released in any press release- other than of course the mention of the disappearing spleen lesion patient having an increased CA 125 over course of treatment.

More recently we have heard about the CT scans stable for some ovarian CA pts at 3 and 6 months. And of course there is the thymoma pt. ASCO 2015 presentation says that this is a 48 yo man , patient 129, 8th cohort. Apparently he is stable and getting kevetrin for 11 months.

What does that tell us about other 8th cohort pts? How about patients 124 and 126 and 206, all with ovarian CA, and patients 130 and 131 with endometrial CA? Of course we know nothing for certain about them, how long they got Kevetrin, or whether biomarkers stabilized, or if they had CT scans that were stable. Some of these pts must have been the basis for the stable CT scan data and for the ovarian CA orphan drug application and approval.

One can surely say that the juicy morsels come from CTIX and that the Shapiro presentations do not give much away.

Also: I was surprised to read on the website that Bologna cannot start until more is known about the MTD from phase 1- just as thought- and it is the CTIX part that needs clarification, not a prolem on the Italian end.
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