Thursday February 28, 9:49 am Eastern
SOURCE: Schering AG
BERLIN - Schering AG (FSE: SCH, NYSE: SHR) today announced the start of the multicenter phase III study, BENEFIT, to investigate the efficacy and safety of interferon beta-1b (Betaferon® / Betaseron®) in persons with first clinical symptoms indicative of MS.
"There is as yet no licensed treatment for more than 100,000 persons worldwide in this group with high risk of developing clinically definite MS and the impact of such an early treatment on the course of the disease remains controversial," said Dr. Joachim-Friedrich Kapp, Head of Specialised Therapeutics at Schering AG. "The results obtained will be of great significance for our understanding of early treatment with high-dose, high frequency Betaferon® / Betaseron®. BENEFIT -- together with the long-term follow-up study -- will provide the necessary answers for the best benefit of people with MS."
BENEFIT (Betaferon®/Betaseron® in newly emerging multiple sclerosis for initial treatment) will be conducted in up to one hundred centres in 21 countries and will include a total of 400 patients presenting with a first clinical episode suggestive of MS, who will be treated with Betaferon® for a period of up to 24 months.
The BENEFIT study seeks to identify the effect of early treatment prior to the second attack as well as to investigate the impact on the formation of new brain lesions as measured by magnetic resonance imaging (MRI). It will be conducted in specialist centers in all European Union countries, Switzerland, some eastern European countries, Canada and Israel. Patients with a first clinical demyelinating event suggestive of MS and typical MRI findings will either receive eight million units of interferon beta-1b (Betaferon®) every other day or placebo as a subcutaneous injection. Treatment will continue for up to 24 months unless they suffer a second attack leading to a diagnosis of clinically definite MS. All study participants will then be entered into a separate follow up study with all patients being offered the option of receiving Betaferon®/ Betaseron® for at least another 36 months. This design will provide the first opportunity to investigate the long-term effects of early vs delayed treatment on disease progression in a rigorous manner.
"With recent diagnostic advances we are more confident about the interpretation of the first symptoms suggestive of MS," said Prof. Ludwig Kappos of the Neurological Clinic at Basle University and member of the BENEFIT Steering Committee. "Previous trials with lower weekly dosages of beta-interferons have shown that this treatment can delay the advent of a second relapse. Investigation of the high-dose, high-frequency treatment regimen of Betaferon®/ Betaseron® in the BENEFIT study is the logical follow up to these early findings. It allows us to explore if we can improve on these results and if early treatment has also an impact on the overall evolution of the disease."
Schering AG is a research-based pharmaceutical company. Its activities are focused on four business areas: Fertility Control & Hormone Therapy, Diagnostics & Radiopharmaceuticals, Dermatology as well as Specialized Therapeutics for disabling diseases in the fields of the central nervous system, oncology and cardiovascular. As a global player with innovative products Schering AG aims for leading positions in specialized markets worldwide. With in-house R&D and supported by an excellent global network of external partners, Schering AG is securing a promising product pipeline. Using new ideas, Schering AG aims to make a recognized contribution to medical progress and strives to improve the quality of life.
An electronic version of this news release -- as well as additional information about Schering AG -- is available at http://www.schering.de/eng
Certain statements in this press release that are neither reported financial results nor other historical information are forward-looking statements, including but not limited to, statements that are predictions of or indicate future events, trends, plans or objectives. Undue reliance should not be placed on such statements because, by their nature, they are subject to known and unknown risks and uncertainties and can be affected by other factors that could cause actual results and Schering AG's plans and objectives to differ materially from those expressed or implied in the forward-looking statements. Certain factors that may cause such differences are discussed in our Form 20-F and Form 6-K reports filed with the U.S. Securities and Exchange Commission. Schering AG undertakes no obligation to update publicly or revise any of these forward-looking statements, whether to reflect new information or future events or circumstances or otherwise.
SOURCE: Schering AG
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