Nationwide Enrollment Under Way in Multi-Center Study
March 17, 2003, 7:33 am ET
Source: Berlex Laboratories
Berlex Laboratories, Inc., the U.S. affiliate of Schering AG, Germany (NYSE: SHR - News), today announced the start of a new clinical study to evaluate the effect of dose and frequency of beta interferon in patients with relapsing-remitting multiple sclerosis (MS). The study, known as "ABOVE" (Interferon beta-1a vs. Interferon beta-1b Observation of Efficacy), will compare the outcome of continuing once-weekly Avonex® (interferon beta-1a) versus changing to a high-dose, high-frequency regimen with Betaseron® (interferon beta-1b) for SC Injection.
Of the available disease-modifying MS treatments, beta interferons are the most studied and most widely used. These drugs are approved for use in patients with relapsing-remitting MS. Individually, the interferons may differ in their side effect and efficacy profiles, as well as dose and frequency and route of administration. Avonex is injected into the muscle once a week at a dose of 30 mcg, whereas Betaseron is injected under the skin every other day at a dose of 250 mcg.
"The ABOVE study will address several questions that previously have not been answered in full. For example, what are the effects of increasing the dose and frequency of beta interferon in relapsing-remitting patients who are on an established beta interferon regimen?" said Douglas S. Goodin, MD, a Professor of Neurology at the University of California, San Francisco and the lead investigator of the ABOVE study. "In addition, because ABOVE is such a large clinical trial that will be carried out for two full years, it will provide more complete answers to questions about the effect of neutralizing antibodies on interferon response and about differences in individual response patterns to interferon in patients with MS."
In this randomized, rater-blinded study, patients diagnosed with relapsing-remitting MS who currently are being treated with Avonex -- and have received the drug for at least the previous six months -- will randomly be assigned to either continue Avonex treatment or change to Betaseron. Patients who are treated with Betaseron will increase their dose over several weeks according to the study protocol. Patients in both treatment arms will be followed for a total of two years. Primary efficacy will be measured by the number of patients who are relapse-free at the end of the treatment period, comparing those treated with Betaseron and those treated with Avonex.
Throughout the study, investigators will monitor the status of patients through a variety of clinical measures and MRI scans, all of which will be assessed in a blinded manner. ABOVE also will compare the safety and tolerability of the treatments. Patients will be required to make regularly scheduled (as well as clinically necessary) visits to treatment centers during the study. Centers will call the patients routinely between visits to monitor their progress.
This will be the largest therapeutic MS study ever conducted, involving more than 75 research centers nationwide. Patient enrollment is beginning immediately and will continue through 2004. Once enrolled, each patient will be treated for two years.
"The ABOVE study represents Berlex's commitment to provide the MS community with new data from well-designed, scientifically innovative clinical studies to help them make informed treatment decisions," said Ayad Abdulahad, MD, PhD, Vice President, Head of Clinical Development and the ABOVE Study Director. "Previous studies have shown that high-dose, high-frequency beta interferon may provide a better therapeutic benefit for patients with relapsing-remitting MS. With ABOVE, we will evaluate patients who take a lower-dose, lower-frequency beta interferon regimen and explore the dose -- and frequency-dependent effect of changing to Betaseron -- specifically, whether patients achieve a better clinical result."
In addition to ABOVE, Berlex has several ongoing studies with Betaseron in potential new indications and new combinations. The company also is developing a number of oral agents to treat MS, and continues to improve upon its successful patient support services.
MS is a disease of the central nervous system affecting the brain and spinal cord. It is estimated to affect more than 350,000 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 10 years. At this stage, after periods of intermittent attacks and remissions, the disease begins a course of steady progression.
Betaseron was the first therapy approved in the United States to treat relapsing-remitting MS. In January 2002, the FDA approved a new room-temperature formulation of Betaseron. Betaseron is the first and only interferon therapy available as a room-temperature formulation (25 degrees C/77 Degrees F) for MS, providing a convenient option for MS patients in the United States.
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.
Serious side effects include depression, suicide, suicidal ideation, and injection site necrosis (skin breakdown, drainage of fluid and tissue destruction), which have been reported in 5 percent of patients in a controlled MS trial. The necrotic lesions are typically 3 cm or less in diameter, but larger areas have been reported, and they may occur at single or multiple sites.
Common side effects of Betaseron therapy include flu-like symptoms, shortness of breath, menstrual disorders, and injection site reactions (redness, pain, swelling, and blue-black discoloration have been reported).
For full prescribing information, please visit www.betaseron.com.
About Berlex Laboratories
Committed to developing novel diagnostics and therapeutics that address unmet medical needs, Berlex Laboratories, Inc. develops and markets ethical pharmaceuticals in the areas of Female Healthcare, Diagnostic Imaging, Dermatology, Oncology and Therapeutics for life-threatening and disabling diseases. Berlex Laboratories, Inc. has business operations in Montville and Wayne, New Jersey, Richmond and San Diego, California as well as Bothell and Seattle, Washington. For more information about Berlex and its products, you may visit our website at www.berlex.com.
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Source: Berlex Laboratories
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