ApoPharma Inc. highlights presentation at the 13th European Hematology Association meeting

Toronto, June 12, 2008 - ApoPharma Inc. today announced the presentation of data from a cross-sectional study of thalassemia major patients in Italy comparing MRI T2* values and LVEF% in patients receiving deferiprone (Ferriprox®), desferrioxamine (Desferal®) or deferasirox (Exjade®) conducted under the auspices of the MIOT group in Pisa, Italy at the 13th European Hematology Association meeting.

Ferriprox® and T2*
Dr. Alessia Pepe, a cardiologist from the Institute of Clinical Physiology in Italy, presented the first comparison of the three iron chelators on the effectiveness of myocardial iron chelation entitled 'Comparison of deferasirox (Exjade®), deferiprone (Ferriprox®), and desferrioxamine (Desferal®) effectiveness on myocardial iron concentrations and biventricular function by quantitative MR in beta-thalassemia major'.

The investigators identified 3 groups of patients; 24 treated with deferasirox, 42 treated with deferiprone and 89 treated with desferrioxamine. The 3 groups were matched for gender, hemoglobin pre-transfusions levels, age of starting chelation, and good compliance to the treatment.

Study results
The deferasirox group was significantly (p=0.0001) younger (26±7 years) than the deferiprone (32±9 years) and the desferrioxamine group (33±8 years) at the time of the study. Mean serum ferritin levels in the deferasirox group (2516±2106 ng/mL) were significantly higher (p=0.0001) than those treated with deferiprone (1493±1651 ng/mL) or desferrioxamine (987±915 ng/mL)

The T2* in the mid ventricular septum was significantly higher (P = 0.0001) in the deferiprone (36 ±12 ms) vs. the deferasirox (20±12 ms) and desferrioxamine groups (28±13 ms). Also, the number of segments with normal T2* value was significantly higher (P = 0.0001) in the deferiprone and the desferrioxamine groups vs. the deferasirox group (14±2 vs. 11±6 vs. 7±7 segments; p=0.0001) and the global heart T2* value in the deferiprone group (34±11 ms) was significantly higher vs. the deferasirox (21±12 ms) and desferrioxamine groups (27±11 ms) (p=0.0001). Additionally, when examining the biventricular function parameters, the left ventricular ejection fractions (LVEF%0) in the deferiprone and desferrioxamine groups were significantly higher (p=0.005) than the deferasirox group (64±7 vs. 62±6 vs. 58±7)

Dr Pepe indicated that "oral deferiprone seems to be more effective than oral deferasirox and subcutaneous desferrioxamine in removal of myocardial iron with concordant positive effects on left global systolic function"

About the MIOT study
MIOT (Myocardial Iron Overload in Thalassemia) is an Italian network of Magnetic Resonance (MR) sites where the cardiac and liver iron status is assessed by validated and homogeneous standard procedures. Myocardial iron concentrations and distribution were measured using the MRI T2* multislice, multiecho technique. Biventricular function parameters are quantitatively assessed by cine-dynamic MRI images, while liver iron concentrations are measured by the MRI T2* multiecho technique. At the time of the study, only 6 centres were involved, however, it has subsequently grown to 8 centres (Pisa, Ferrara, Ancona, Rome, Campobasso, Palermo, Catania, Lamezia Terme)

About the role of myocardial iron
Magnetic resonance T2* values of the myocardium are directly related to tissue iron levels. Myocardial T2* values less than 20 ms indicate iron overload, and this is considered severe when T2* is less than 10 ms. Decreasing myocardial T2* levels are associated with systolic and diastolic ventricular dysfunction. Most recorded cases of heart failure in thalassemia major to date have occurred in patients with very low T2* values (in the severe range). Exceptions to this have occurred in patients with other causes of heart failure such as concomitant congenital heart disease.

In patients presenting with heart failure who undergo aggressive chelation with continuous intravenous desferrioxamine, longitudinal studies show that myocardial T2* increases, and this is accompanied by increases in ejection fraction and relief of heart failure. In cross-sectional studies, the myocardial T2* and ejection fraction of patients on deferiprone has been shown to be superior to that of patients on desferrioxamine (DFO).

About ApoPharma
ApoPharma is the innovative drug development member of the Canadian-owned Apotex Group of Companies. ApoPharma is developing medications primarily in the fields of Iron Chelation and psoriasis.