Monday, December 29, 2014 4:07:31 PM
"The trial is currently enrolling patients in the ninth cohort. Preliminary data show that 50 percent of patients treated with Kevetrin through the eighth cohort demonstrated enhancement in p21 expression in peripheral blood cells, and that these observations appeared dose-related. The biomarker p21 is tightly controlled by the tumor suppressor protein p53, which is often referred to as the “Guardian Angel Gene” because of its crucial role in controlling cell mutations. Initial comparisons between early and latter cohorts support Cellceutix’s expectations that p53 activation is dependent on extent of exposure to Kevetrin. These results support the hypothesis that Kevetrin has pharmacological activity in patients.
Kevetrin continues to be generally well-tolerated with no evidence of hematologic toxicity. One patient who received the highest dose of Kevetrin administered (350 mg/m2) experienced a dose-limiting toxicity (DLT). At the request of the patient and approval by the physician, the patient continues on the study, but at a reduced Kevetrin dose with no further DLT events. A maximum tolerated dose (MTD) has not been determined in this trial, to date"
- See more at: http://cellceutix.com/patient-enrollment-in-cellceutix-phase-2-clinical-trial-of-brilacidin-om-for-oral-mucositis-targeted-to-begin-in-december-2014/#sthash.s96mUYHF.dpuf
With dose-related p21 levels we should be able to crack the 50% enhancement in p21 levels at higher cohorts especially given the 10% threshold they put on p21 levels. I have been hoping for dose-related p21 levels statements for years now!
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