Novuspharma SpA plans to begin a phase I trial of pixantrone (BBR 2778) in patients with multiple sclerosis (MS) in early 2003. The trial is expected to recruit 15-20 patients in Europe.The main goal of this study is to define the dose of pixantrone to be used in longer term clinical trials, and to obtain preliminary activity data.

Patients will receive four infusions of pixantrone every three weeks, with a starting dose of 120 mg/m2.The effect of pixantrone on patients' brain lesions will be assessed by magnetic resonance imaging (MRI) at the start of the trial and at two, four and six months thereafter.Pixantrone's cardiac safety profile will also be assessed at these time points by using a multiple gated acquisition (MUGA) scan to measure the left ventricular ejection fraction of the heart.

Additional endpoints will include general safety and tolerability and number of pixantrone infusions required to induce significant lymphopenia (a reduction in the white blood cell count, pixantrone's primary mechanism of action in this indication).

The trial plans to enroll patients between the age of 18 and 55 with relapsing-remitting or relapsing-progressive MS, as defined by the McDonald criteria.Patients should have a disease duration of not more than 15 years and an Expanded Disability Status Scale Score (EDSS) between 1 and 5.5. Patients that have been treated with an immunosuppressor, such as mitoxantrone, in the past year will be excluded from the study.

At the same conference, a summary of previous pre-clinical data for pixantrone in MS was also presented.This included the results of a study in a chronic model of MS in rats (experimental autoimmune encephalomyelitis, EAE), which demonstrated that pixantrone was effective at preventing disease relapses and reducing white blood cell counts and suggested it was possibly more efficacious than mitoxantrone.This study also suggested an almost complete absence of cardiotoxicity compared to mitoxantrone.

In addition, new data for pixantrone in a chronic model of EAE in mice was also presented, which demonstrated that pixantrone was highly efficacious at preventing disease development, as well as being better tolerated than mitoxantrone.These data were generated by an independent group of scientists, led by Prof. Dr. B. Dubois from the University of Leuven in Belgium.

Mitoxantrone is currently the only treatment option for many patients with rapidly progressing forms of MS.However, its use is limited to 2-3 years due to its cumulative cardiotoxicity. Pixantrone is currently in phase III studies for the treatment of non-Hodgkin's lymphoma (NHL).

Silvano Spinelli, Chief Executive Officer, said: "If pixantrone's improved safety and efficacy profile is confirmed in the clinic, it should allow for the earlier and more prolonged treatment of severe MS patients.At Novuspharma we plan to continue our focus on developing improved cancer therapeutics but will not neglect the potential of our products in other therapeutic areas, which should prove attractive to partners wishing to conduct late stage development in these indications."