Quinamed® (amonafide dihydrochloride) is a synthetic organic compound with established anti-cancer clinical activity. We have recently discovered that amonafide affects a number of targets in the EGFR pathway. In NCI-sponsored clinical studies with amonafide monohydrochloride, response rates as high as 25% were observed in breast cancer. However, researchers also noted some unpredictable side effects. It was later discovered that differences in how patients metabolize the drug has a significant impact on toxicities. These metabolic differences can now be determined by testing a patient’s NAT2 genotype.

Our personalized medicine development strategy is to determine a patient’s NAT2 genotype and then treat them with the precise dose needed to produce the optimal result. In our ongoing Phase 1/2a clinical trial, investigators have already been able to achieve a higher overall dose intensity using a weekly schedule without observing unexpected side effects.

We have recently completed a Phase 2a study with prospective dosing based on NAT2 genotype in patients with refractory prostate, ovarian or breast cancers who have failed chemotherapy. Data from the phase 2a trial was presented at the ASCO Annual Meeting in Chicago in June, 2007. The key outcomes from the study were (i) demonstration that dose level could be optimised according to patient genotype, (ii) the drug was well tolerated, with predictable and manageable side effects, and (iii) there was evidence of anticancer activity in several solid tumor types.

We have two issued patents and eight additional patent applications covering the composition of matter for both organic and inorganic salts of amonafide, formulations, synthesis and uses.