April 29, 2004
Source: Berlex, Inc.
Berlex, Inc., a U.S. affiliate of Schering AG Germany, today announced that early results from the first phase of the multiple sclerosis (MS) BEYOND program show that a new, higher dose of Betaseron(R) (interferon beta-1b) for SC injection may have a positive effect in relapsing-remitting MS patients, compared to the standard Betaseron dose. The data -- the first efficacy outcomes from the study -- were presented at the 56th Annual Meeting of the American Academy of Neurology in San Francisco.
"Building on the vast body of evidence supporting high-dose, high- frequency beta interferon in treating relapsing-remitting MS, early data from this study appear to suggest that a higher dose -- double the approved dose of Betaseron -- may provide an even greater therapeutic benefit to patients," said Douglas R. Jeffery, M.D., Ph.D., Associate Professor of Neurology, Wake Forest University School of Medicine, and a study investigator. "If we can achieve similar efficacy results in the larger patient population enrolled in BEYOND, this higher Betaseron dose could represent an effective, new treatment choice for patients."
The BEYOND (Betaseron Efficacy Yielding Outcomes of a New Dose) program is an ongoing multinational, Phase III trial and one of the largest MS studies ever, involving more than 2,000 patients. The study will compare the relative efficacy of Betaseron 500 mcg every other day, Betaseron 250 mcg every other day, and glatiramer acetate (Copaxone(R)) 20 mg administered subcutaneously every day in patients with relapsing-remitting MS. Last September, Berlex announced safety and tolerability results from the first phase of the program, which showed that both the standard, currently approved Betaseron dose (250 mcg) and the new double dose of Betaseron (500 mcg) were well tolerated, with no new or unpredictable side effects.
This double-blind, randomized, parallel group study was part of the first phase of the BEYOND program (designed to assess safety and tolerability), in which 71 relapsing-remitting MS patients with no previous treatment were randomized to receive either Betaseron 250 mcg or Betaseron 500 mcg for at least 12 weeks.
Patients in both groups increased their dose of Betaseron during the first six to 12 weeks and maintained at the target dose for the duration of the study. Patients experiencing adverse events were allowed to reduce their dose. In keeping with other large-scale clinical trials, an Independent Data and Safety Monitoring Board (IDSMB) reviewed pre-planned interim and final outcomes and advised on their findings.
The results indicated that the Betaseron 500-mcg-treated group showed greater median percentage change from baseline in T2-weighted lesion volume at 12 weeks, suggesting a trend toward a greater treatment effect compared to Betaseron 250 mcg (-6.9 % for Betaseron 500 mcg vs. -1.8% for Betaseron 250 mcg). In addition, the mean number of active lesions decreased by 90% on the 500-mcg dose and by 70% on the 250-mcg dose.
MS is a disease of the central nervous system affecting the brain and spinal cord. It is estimated to affect more than 400,000 people in the United States and is the major acquired neurologic disease in young adults. People who develop MS may not immediately recognize their condition, because the symptoms of MS are nonspecific and may be similar to those of other diseases. Common signs and symptoms of MS include fatigue, psychological and cognitive changes, weakness or paralysis of limbs, numbness, vision problems, speech difficulties, problems with walking or motor skills, bladder problems, and sexual dysfunction.
Relapsing-remitting forms of MS are characterized by periods of attacks, interspersed with stable periods. Most symptomatic patients are classified at onset with the relapsing-remitting form of the disease. About 50 percent of patients with relapsing-remitting disease advance into the secondary progressive form within ten years. At this stage, after periods of intermittent attacks and remissions, the disease begins a course of steady progression.
Chiron Corporation and Berlex jointly developed Betaseron(R). It is manufactured by Chiron and sold in the United States and Canada by Berlex.
Betaseron was the first therapy approved in the United States to treat relapsing-remitting MS. Betaseron is indicated for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations. Relapses are repeat attacks during which new symptoms appear or existing symptoms worsen, followed by periods of recovery. Relapsing forms of MS include relapsing- remitting, the most common form, and secondary progressive MS with relapses.
In January 2002, the FDA approved a new room-temperature-stable formulation of Betaseron. Betaseron is the first and only interferon therapy available in the United States that is stable at room temperature (25 degrees Celsius / 77 degrees Fahrenheit) for more than 30 days, providing a convenient option for MS patients. Injections for this formulation should be administered immediately after preparation. If the injection is delayed, the solution should be refrigerated and injected within a three-hour time period.
The recommended dose of Betaseron (interferon beta-1b) is 250 mcg (8 MIUs) every other day, which delivers an average total of 875 mcg (28 MIUs) per week.
The most commonly reported adverse reactions are lymphopenia, injection site reaction, asthenia, flu-like symptom complex, headache, and pain. Betaseron should be used with caution in patients with depression. Injection site necrosis has been reported in 5 percent of patients in controlled trials. Patients should be advised of the importance of rotating injection sites. Female patients should be warned about the potential risk to pregnancy. Cases of anaphylaxis have been reported rarely. (See "Warnings," "Precautions," and "Adverse Reactions" sections of Prescribing Information.)
Committed to developing novel diagnostics and therapeutics that address unmet medical needs, Berlex, Inc., a U.S. affiliate of Schering AG, Germany (NYSE: SHR), develops and markets diagnostic imaging agents and treatments in the areas of female healthcare and dermatology, as well as specialized therapeutics for life-threatening and disabling diseases in the fields of the central nervous and cardiovascular systems, oncology and gastroenterology. Berlex has business operations in New Jersey, California and Washington. For more information, please visit http://www.berlex.com.
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