Genta Incorporated has announced the publication of findings from a phase III trial of the company's lead anticancer drug, Genasense (oblimersen sodium) Injection, when used in combination with chemotherapy for treatment of patients with relapsed or refractory chronic lymphocytic leukaemia (CLL).

The findings were published on-line this week in the Journal of Clinical Oncology, ahead of its tentatively scheduled print publication date of March 20, 2007.

Conducted at 100 centres in the US, Europe, Canada, Australia and South America, patients with relapsed or refractory CLL received fludarabine plus cyclophosphamide (Flu/Cy) chemotherapy with or without Genasense. This trial - the first randomised study ever conducted in this population - achieved its primary endpoint, which was a statistically significant increase in the proportion of patients who achieved a complete or nodular partial response (CR/nPR).

Patients who achieved CR/nPR experienced the disappearance of all predefined CLL symptoms, including fever, night sweats, fatigue, abdominal discomfort due to an enlarged spleen, and impaired mobility due to swollen lymph nodes.

The key secondary endpoint - duration of CR/nPR - was also significantly longer for patients treated with Genasense (median = not reached but will exceed 36+ months in the Genasense group vs. 22 months for patients treated with chemotherapy alone).

Among patients who achieved a CR/nPR with Genasense, 70 per cent were alive at three years versus 38 per cent for the control arm. Among patients who achieved a partial response, 45 per cent who received Genasense were alive at three years compared to 33 per cent for the control arm.

The lead and senior authors of the article are, respectively, Dr Susan O'Brien, Professor of Medicine, Department of Leukaemia, MD anderson Cancer Centre, and Dr Kanti R. Rai, Chief, haematology and oncology, North Shore/Long Island Jewish Medical Centre, and Professor of Medicine, Albert Einstein College of Medicine.