Preclinical Data Presented at 12th Meeting of the European Neurological Society in Berlin
June 24, 2002
Novuspharma SpA (Nuovo Mercato: NOV.MI), a biotechnology company focused on cancer, today announces results from a preclinical study with BBR 2778 in a chronic model of multiple sclerosis. The results were presented by Dr Guido Cavaletti of the Bicocca University of Milan, together with colleagues and Novuspharma scientists, at the 12th Meeting of the European Neurological Society in Berlin being held from 22 to 26 June 2002. BBR 2778 is Novuspharma's novel intercalating agent currently in Phase III clinical trials for the treatment of Non Hodgkin's lymphoma.
The aim of the preclinical experiments was to examine the effect of BBR 2778 in a chronic, relapsing, experimental autoimmune encephalomyelitis (EAE) model of multiple sclerosis by comparing BBR 2778 with mitoxantrone, an anti-cancer drug approved in US and certain European Countries for the treatment of multiple sclerosis. The rationale for the study was based on encouraging findings from an independent preliminary study by Dr Gonsette (University of Leuven, Belgium) presented last year at the ECTRIMS conference in Dublin, Ireland (see press release of 13 September 2001).
The data analysed so far indicate that repeated intravenous administration of both mitoxantrone and BBR 2778 is effective in preventing disease relapses, and there are some suggestions of better efficacy of BBR 2778 than mitoxantrone at the dose level tested. These results are consistent with the effects seen on the white blood counts: both agents induced a similar and significant reduction in total white blood cell count in comparison with the control group. Lymphocytes were reduced accordingly, but more markedly after BBR 2778 administration. The reduction was still evident at the end of the 60 day observation period. Histopathology confirmed previous observations in addition to showing evidence of BBR 2778's non-cardiotoxic properties.
Dr Silvano Spinelli, Chief Executive Officer of Novuspharma, said: "With these results we are now closer to showing pharmacological proof of concept in the treatment of multiple sclerosis with BBR 2778, broadening the product's potential into a new indication. The next step will be to define a minimum effective dose and an adequate schedule of administration for the start of clinical trials."
For a copy of the abstract from today's presentation, please contact Financial Dynamics on +44 (0) 20 7831 3113.
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 auto-immune disease mediated, at least in part, by auto-reactive T lymphocytes.
Current Treatments for Multiple Sclerosis
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 anti-neoplastic drug with potent immuno-suppressive 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. Current treatments for MS represent a potential $2bn plus market which is expected to grow to c.$3bn by 2004.
Novuspharma, based in Bresso, Milan, is an emerging biopharmaceutical company leveraging its expertise in the field of oncology to discover and develop innovative new treatments for cancer. It has four products in clinical development and a dynamic research programme. Novuspharma's leading anti-cancer drug, BBR 2778, has recently begun Phase III clinical trials in indolent Non-Hodgkin's Lymphoma. Novuspharma was established in 1998 following the merger of Boehringer Mannheim and Hoffmann-LaRoche, to exploit the R&D team's proven track record in product development. Novuspharma makes use of a complete range of discovery and development platforms and focuses its specific expertise on the most critical part of the development process from the initial identification of leads to late clinical development stages as far as New Drug Application.
Novuspharma has recently relocated its headquarters and research operations to join the growing number of start-up biotechnology and healthcare enterprises already situated in Bresso. One of the objectives of the relocation was to enable Novuspharma, as one of Italy's publicly-quoted biotechnology companies, to foster bio-entrepreneurship within the country and encourage the development of an innovative research environment.
For further information, please visit the Company's web site at http://www.novuspharma.com .
SOURCE Novuspharma SpA
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