Pete - this is what ctix deems unacceptable: "Dose Limiting Toxicities (DLT) of Kevetrin. [ Time Frame: up to 4 weeks ] [ Designated as safety issue: Yes ] The definition of dose limiting toxicity (DLT) is in accord with the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE). Dose limiting toxicity will be defined as: These are the pharmacodynamic toxicity effects seen in animal studies:"GLP Toxicology and Safety Pharmacology Studies of Kevetrin And this: Toxicology and Safety Pharmacology of Kevetrin Humans starting at much lower dose. Animals treated to DLT. My guess is humans may experience some of the milder effects known to chemo drugs - nausea, vomiting, diarrhea, alteration in cbc reflecting some dehydration - but nothing severe - because even at maximum dose the animals tolerated fairly well. Would love to hear other opinions on this.
Repeat dose toxicology studies: IV weekly x 5 weeks
• Rats (60, 90, 120 mg/kg) NOAEL = 90 mg/kg
o minor changes in hematology, clinical chemistries
Cardiovascular effects: 60 mg/kg (dogs)
• No effect on ECG
• Transient increase in heart rate, arterial pressure, diastolic
pressure resolved within 7 hours after dosing
Dogs (5, 25, 60 mg/kg) NOAEL = 5 mg/kg Cellceutix is a publicly traded company, stock ticker: o vomiting, loose stool, diarrhea (during dosing only)
biologically significant decrease in MCHC and
increases in RBC, hematocrit, and sodium (high
dose)
Neurological effects: 120 mg/kg IV (rats)
• No apparent neuropharmacological, temperature effects
Pulmonary effects: 120 mg/kg IV (rats)
• No biologically relevant effects on respiratory rate, tidal
volume or minute volume
Repeat dose toxicology studies: IV weekly x 5 weeks
• Rats (60, 90, 120 mg/kg) NOAEL = 90 mg/kg
minor changes in hematology, clinical chemistries
• Dogs (5, 25, 60 mg/kg) NOAEL = 5 mg/kg
iti l t l di h d i d i l )
Cardiovascular effects: 60 mg/kg (dogs)
• No effect on ECG
• Transient increase in heart rate, arterial pressure, diastolic
pressure – resolved within 7 hours after dosing
Neurological effects: 120 mg/kg IV (rats) p y p y
o vomiting, loose stool, diarrhea (during dosing only)
o biologically significant decrease in MCHC and
increases in RBC, hematocrit, and sodium (high dose)
• No apparent neuropharmacological, temperature effects
Pulmonary effects: 120 mg/kg IV (rats)
• No biologically relevant effects on respiratory rate, tidal
volume or minute volume
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