Innovation Pharmaceuticals Inc (IPIX)

[farrell90]

Nice summary. There is a lot we do not know. The FDA phase 1 study data will be scoured for information which will contribute to the dosage and frequency of administration.

"Surely, Cellceutix and Dana Farber are working to determine necessary Kevetrin serum levels, the risk/benefit of higher levels of exposure, the importance of continuous exposure, the duration of clinical effect, and if this clinical effect correlates with various biomarkers."


Questions which may be answered:

At what dose did tumor biomarkers start to decline?
Did the P21 biomarker levels peak at a certain dosing levels.
Did the imaging demonstrate responses at a certain doses and did higher doses improve responses.
At what dose did clinical signs of improvement [eg weight gain,less pain, improved activity] develop.

Pharmacokinetic data will help determine the dosing.Degree of protein binding,plasma and peak plasma concentrations, renal and hepatic excretion, volume distribution and other factors will give insight to the dosing.

Were active metabolites discovered? Was the SER binding site on P53 bound tightly by Kevetrin to increase the biologic effect?

The fact that Kevetrin: is not genotoxic; does not produce myelodepression, renal or hepatic toxicity; produced no DLTs and the MTD was not achieved but was declared will give the researchers a lot of flexability in selecting safe and effective dosing.

GLTA, Farrell