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Re: TheDane post# 43884

Thursday, 10/17/2013 8:29:59 AM

Thursday, October 17, 2013 8:29:59 AM

Post# of 403414
That is correct... restaging is more common in clinical research as a means to assess performance of the treatment... restaging can indicate improvement or worsening of the disease course... of course...

However, it is clear in the case of K from the r&r report... slide #9 of 18... that the restagings in the p1 were commensurate with "stabilization" of disease... so this is a good thing in a stage 4 cancer patient with a progressive, treatment-resistant cancer...

Slide #9 quoted below... r&r presentation can be easily accessed on the company website for any new folks who have not had the opportunity to see it...

Finally, in re-reading this I am intrigued by the line that gov has quoted recently... "Disease progression occurred following stabilization of disease in some cases", which does seem to imply that at least at the time this slide was created stabilization continued unabated for "some" of the six... wouldn't make too much of this at this early stage... but it is intriguing to say the least... again all of these early efficacy hopeful indicators are at what the clinicians suggest will likely be sub-optimal doses of K... slide #9 quotes follow:


"Observed stabilization of disease by restaging in multiple types of cancer
•Evidence of stable disease by radiological examination in 6 cases, which includes head and neck cancer, ovarian cancer, liposarcoma and clear cell carcinoma
•Disease progression occurred following stabilization of disease in some cases
•Subject 103 had 6 months of treatment and 2 successful restaging with stable disease
•Subject 202 completed 4 cycles of treatment
*Stabilization was achieved at low doses in terminal patients with relapsed tumors that were resistant to current chemotherapies.
Pharmacokinetic profiles and parameters show no evidence of accumulation in plasma
•This points to possibility to increase dose and frequency
p21 biomarker expression in patients
•Kevetrin activated p21 in 4 out of 5 patients treated with 20 or 30 mg/m2"
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