KEVETRIN PHASE 1 DATA POINTS

With the trial start imminent, here is a chronological summary of phase 1 trial data points and measures:  

Primary Outcome Measures:  
Dose Limiting Toxicities (DLT) of Kevetrin. [ Time Frame: up to 4 weeks ] 
Maximum Tolerated Dose (MTD) of Kevetrin [ Time Frame: up to 6 months ]


DAY 1 TO TAKE PLACE ON/AROUND THURSDAY, NOV 1ST, 2012 (WITHIN A FEW DAY WINDOW)


Secondary Outcome Measures:

DAY 1 :
Pharmacokinetic Profile of Kevetrin [ Time Frame: Day 1 Pre-dose, 30 minutes after starting the infusion, 1 hr, 1 hr 10 min, 1 hr 20 min, 1 hr 30 min, 1 hr 45 min, 2 hr, 2 hr 30 min, 3 hr, 4 hr, 5 hr, 7 hr, and 24 hr after the initiation of the infusion ]

DAY 1 :
Changes in the biomarker p21 in peripheral blood lymphocytes [ Time Frame: baseline and 7 hours ]

DAY 1 :
Changes in the biomarker p21 in peripheral blood lymphocytes [ Time Frame: baseline and 24 hours ]

DAY 15 :
Pharmacokinetic Profile of Kevetrin [ Time Frame: Day 15 Pre-dose, 30 minutes after starting the infusion, 1 hr, 1 hr 10 min, 1 hr 20 min, 1 hr 30 min, 1 hr 45 min, 2 hr, 2 hr 30 min, 3 hr, 4 hr, 5 hr, 7 hr, and 24 hr after the initiation of the infusion ]

DAY 30 :
Decrease in serum tumor marker [ Time Frame: baseline and 1 month ]


DAY 60 :
Change in tumor size [ Time Frame: baseline and 2 months ]

DAY 60 :
Decrease in serum tumor marker [ Time Frame: baseline and 2 months ]

DAY 90 :
Decrease in serum tumor marker [ Time Frame: baseline and 3 months ]

DAY 120 :
Change in tumor size [ Time Frame: baseline and 4 months ]

DAY 120 :
Decrease in serum tumor marker [ Time Frame: baseline and 4 months ]

DAY 150 :
Decrease in serum tumor marker [ Time Frame: baseline and 5 months ]

DAY 180 :
Change in tumor size [ Time Frame: baseline and 6 months ]

DAY 180 :
Decrease in serum tumor marker [ Time Frame: baseline and 6 months ]




That sums it up. That is what we will learn, and in proper chronological order. Very exciting, the will be trial data on a regular basis, lots of talking points and PR material.