More MS news articles for Nov 2001

Novuspharma SpA
BBR 2778 Shows Promise In Preclinical Trials,2,424;

Biotech Week
Issue:   Volume 2001, October 24 & 31, 2001
Page:   3


2001 OCT 24 - ( -- Novuspharma SpA (NOV.MI) announced that Dr. Gonsette from the National Center for Multiple Sclerosis, together with colleagues from the University of Leuven in Belgium, have presented preclinical results on the potential of BBR 2778 as a treatment for multiple sclerosis (MS) at the ECTRIMS conference in Dublin, Ireland.

BBR 2778 is Novuspharma's novel intercalating agent currently in Phase II clinical trials for the treatment of cancer. In his studies, Gonsette evaluated an experimental model of acute autoimmune inflammation of the central nervous system, mimicking MS. In this model, BBR 2778 exerted a protective effect similar to that of mitoxantrone on the development of the disease. The incidence of neurological symptoms was reduced by more than 50% compared with placebo-treated animals. Mortality and disease severity were also significantly decreased, and disease onset was delayed.

Following these preliminary findings, additional studies will be undertaken by Gonsette in chronic models that reflect more closely the human disease.

Multiple sclerosis is a neurological disorder affecting approximately 1.5 million individuals world-wide. In the Western world, it is second only to trauma as a cause of neurological disability arising in early to middle adulthood. The disease derives its name from the multiple scarred areas occurring in the brain of affected subjects. Symptoms include weakness of the limbs with spasticity and disturbances of gait, vision and speech, and bladder and gut dysfunction. The clinical course is relapsing-remitting or progressive, and can vary in an unpredictable way from a benign illness to a rapidly evolving and incapacitating disease. MS appears to be an autoimmune disease mediated, at least in part, by autoreactive T lymphocytes.

Two immunomodulators, interferon beta and glatiramer acetate, are currently approved for the treatment of relapsing-remitting multiple sclerosis. More recently, mitoxantrone has been approved for patients with a severe, progressive form of the disease. Mitoxantrone is an antineoplastic drug with potent immunosuppressive activity, and is effective in reducing MS disease activity in terms of relapse rate, progression of disability and evidence of specific alterations of the magnetic resonance imaging of the brain. The main problem associated with mitoxantrone treatment is the cardiac toxicity that occurs when high cumulative doses are administered.

Dr. Silvano Spinelli, Novuspharma, said: "These preliminary findings from Dr Gonsette further support our plans for investing in the development of BBR 2778, our lead and most important compound. The product is already showing high promise in the therapy of lymphoma, but might have further upside in other indications that we will actively pursue."

BBR 2778, is an intercalating agent which appears to have the potential for reduced cardiotoxicity. The compound was evaluated as a single agent in Phase I and was shown to have potential for the treatment of non-Hodgkin lymphoma. Enrollment of patients for a Phase II study of the drug was completed in Europe during the first quarter of 2001, and relevant data are expected to be released before the end of 2001. Novuspharma has recently been granted Investigational New Drug status by the U.S. Food and Drug Administration in order to assess the drug in various combinations with other therapies prior to the start of preregistration studies, anticipated for the end of 2001.

This article was prepared by Biotech Week editors from staff and other reports.
Copyright 2001, Biotech Week via