SuperGen, Inc. presented an update on results from the company's randomized phase III study of Dacogen (decitabine) for injection, its investigational treatment for myelodysplastic syndromes (MDS), at the UBS Specialty Pharmaceuticals Conference in New York. The presentation, which included new additional subset analysis of investigators' evaluation of clinical responses, indicated an average patient objective response rate (partial and complete) of 25 per cent.

In the 170-patient study, 89 patients were randomized to Dacogen plus supportive care and 81 patients were randomized to supportive care only. The additional analysis shows that the overall patients' response to Dacogen therapy was 25 per cent. Further subset analysis showed that treatment with Dacogen achieved the following positive responses in all specific subtypes of MDS: 17 per cent of patients with chronic myelomonocytic leukaemia (CMML); 25 per cent of patients with refractory anaemia (RA); 26 per cent of patients with RA with excess blasts (RAEB); 29 per cent of patients with RAEB in transformation (RAEB-T); and 14 per cent of those with RA with ringed sideroblasts (RARS).

"We are pleased to be able to provide this additional analysis of our phase III study," stated Dr. James Manuso, president and chief executive officer of SuperGen. "Data for this analysis has now been locked and will be part of the rolling NDA submission that will start this quarter and is projected to be completed in the third quarter."

Adverse events were observed in patients receiving Dacogen more frequently than patients randomized to receive supportive care alone. The most frequent adverse events were observed to be nausea, constipation, diarrhea, vomiting, pneumonia, arthralgia, headache and insomnia. Severe adverse events observed more frequently in patients randomized to Dacogen, categorized as Grade 3 or 4, were leucopenia and febrile neutropenia. The rates of Grade 3-4 sepsis were similar (8 per cent in the Dacogen arm versus 6 per cent in the supportive care only arm). Overall adverse events for Dacogen treated patients were similar to previously reported phase II studies in MDS.