Posted On: 11/15/2016 10:45:31 AM
Post# of 72443
Kevetrin: have multiple FDA orphan drug designations. Starting 2A for platinum-resistant ovarian cancer. p53 central in many types of cancer, esp. ovarian.
Phase 1 trial is supportive of proceeding with ovarian. To measure p53 pathway to establish mechanism of action. Need to shift from intravenous to oral formulation which would allow multiple doses per day.
CHART OF PHASE 1 RESULTS
60% of ovarian patients had increase in p21, downstream marker of p53. 3-73% increase.
1 non-serious adverse effect from infusion, low blood pressure. No other significant adverse effects.
Phase 2A: dose 3x/week, IV, over 3 weeks. 2 dosing groups, 5 in each group (10 total). Will be followed by standard of care treatment with doxil. Will look at pharmacokinetics. Purpose is to establish mechanism of action.
Phase 1 trial is supportive of proceeding with ovarian. To measure p53 pathway to establish mechanism of action. Need to shift from intravenous to oral formulation which would allow multiple doses per day.
CHART OF PHASE 1 RESULTS
60% of ovarian patients had increase in p21, downstream marker of p53. 3-73% increase.
1 non-serious adverse effect from infusion, low blood pressure. No other significant adverse effects.
Phase 2A: dose 3x/week, IV, over 3 weeks. 2 dosing groups, 5 in each group (10 total). Will be followed by standard of care treatment with doxil. Will look at pharmacokinetics. Purpose is to establish mechanism of action.
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