Plough, this toxocity study is probably to establish the limits they can push the dosage to in the phase 2. Coramsine has an excellent safety profile, far superior to chemos. I dont think they can "fail" these tests. As I recall from the phase 1 the most serious side effect was raised liver ensymes which was reversable. Other plant alkaloids(such as leading Sanofi cancer drug Taxotere can cause blackening of the finger tips and worse. Taxotere net sales in 2006 are about $1.5 Billion) that dont have the ability to target the cancer cells over other normal cells can cause serious peripheral nerve damage. As safe as Coramsine is, it is sad the TGA chose to deny it to those people who were about to start the trial. JMHO
SBP
solbec pharmaceuticals limited
