Study Suggests a Continuum of Patients with Varying Ability May Respond to Treatment
Updated 9:15 PM ET May 1, 2000
Current quotes (delayed 20 mins.) CHIR 36 5/8 5/8 (1.74%)
SAN DIEGO, May 1 /PRNewswire/ -- Berlex Laboratories, Inc., distributor of Betaseron(R) (Interferon beta-1b) for SC Injection, and Chiron Corporation (NASDAQ:CHIR), manufacturer of Betaseron(R), released findings from the North American trial of Betaseron(R) in secondary progressive (SP) multiple sclerosis (MS) at the annual meeting of the American Academy of Neurology (AAN). The findings suggest there are clinically important differences among patients diagnosed with SPMS.
Results from the North American secondary progressive MS trial suggest that patients with more advanced disease, characterized by less active inflammatory activity on magnetic resonance imaging (MRI), are less likely to show a measurable response to treatment with interferon beta therapy as measured by the Expanded Disability Status Scale (EDSS). However, there is evidence to suggest that there may be a subset of the patient population -- corresponding to those enrolled in the European SPMS Betaseron(R) trial -- in which clinical treatment with Betaseron(R) slowed the progression of disability. This difference between patient groups may explain why responses in the delay of progression of disability, the primary endpoint of both studies, was statistically significant in the European trial, but did not reach statistical significance in the North American trial.
Side effects seen in the North American secondary progressive MS study were similar to those seen previously in other studies, including flu-like symptoms, dyspnea, menstrual disorders, injection site reactions, and injection site necrosis. The incidence of depression, risk of suicide, or attempted suicide, were the same for patients in the Betaseron(R) arm as the placebo arm of the study.
"This study confirms that Betaseron(R) reduces relapse rates and MRI activity in patients with SPMS. Betaseron delays time to onset of sustained progression of disability in patients with SPMS, but this effect becomes more difficult to demonstrate as patients transition to the less inflammatory phase of SPMS," noted Donald Goodkin, MD, Associate Professor of Neurological and Medical Disorders, Mt. Zion MS Center, University of California at San Francisco, and chairman of the study's steering committee.
At AAN, Henry McFarland, MD, Chief of Neuroimmunology Branch, NINDS, and chairperson of the Independent Monitoring Committee for both studies, presented an analysis of the reasons why the European and North American studies differed in the effect of treatment on progression. He indicated that "based on the consistent effect on progression seen in the European SP study population and on our understanding of the disease process, it is likely that Betaseron is effective in patients in the secondary progressive phase of disease who continue to have an inflammatory component contributing to progression."
In the North American SPMS study, the standard fixed dose of Betaseron(R) appears to reduce the relapse rate, as well as the amount and activity of brain lesions detected by MRI, regardless of baseline MRI. The effects on relapse rates and MRI are consistent with those of the European study and relapsing-remitting studies conducted earlier.
"The cumulative data from all recently completed MS studies suggest that patients be treated as early as possible, before neurological damage becomes too severe," said Barry Arnason, MD, Professor of Neurology, University of Chicago Pritzker School of Medicine, and a study investigator. Several other studies also indicate that treating patients early may slow the development of serious, debilitating consequences for the patient.
The Betaseron(R) database now contains information from studies involving over 1600 people with SPMS, making it the largest collection of controlled clinical treatment information of that condition. When combined with data from the company's extensive relapsing-remitting Betaseron(R) MS study program, Berlex's database represents one of the world's most comprehensive bodies of clinical treatment data on MS.
"We now know about responses to clinical treatment in a broad spectrum of people with MS, from newly diagnosed relapsing-remitting disease through more advanced secondary progressive disease," said Howard Robin, General Manager of Berlex Laboratories. "The cumulative body of data tell us that the best way to fight MS is to treat early and aggressively."
About the Study
The North American study was a double-blind, randomized study of 935 people with SPMS, and involved 34 clinical research centers in the United States and Canada. Patients received placebo, the standard fixed 8 million international units (MIU) dose of Betaseron, or a dose of 5 MIU/m2 that was adjusted for body mass. No significant differences in safety or efficacy were found between the fixed dose and doses adjusted for body mass.
Side Effects Comparable to Established Profile
In the secondary-progressive MS trials, Betaseron(R) demonstrated manageable side effects similar to those seen in previous clinical studies, including flu-like symptoms, injection reactions and injection site necrosis. Other reported side effects associated with Betaseron(R) treatment included muscle hypertonia, hypertension, dyspnea, and menstrual disorders.
Betaseron(R) was the first therapy approved in the United States to treat relapsing-remitting MS. These patients typically have mild to moderate disability with EDSS scores of 0-5.5. The secondary progressive study program examined the safety and efficacy of Betaseron(R) in the higher range of MS disability, which includes EDSS scores of 3.0-6.5.
About 50 percent of people with the relapsing-remitting disease advance into the secondary progressive form. Betaseron(R) is approved for secondary progressive MS in Europe, Canada, and Australia. In these regions, it is the only approved therapy for the treatment of both the relapsing-remitting form as well as the more advanced secondary progressive form of MS.
Betaseron(R) provides patients with 8 MIUs of medicine every other day, for a total of 24-32 MIUs each week. In clinical studies of two dose levels of Betaseron(R) in early stage relapsing-remitting MS, there was a clear correlation between dose and clinical efficacy, leading to the selection of the higher 8 MIU dose as the recommended dosage.
About Berlex & Chiron Corp.
Betaseron(R) was jointly developed by Chiron Corporation and Berlex Laboratories, Inc. It is manufactured by Chiron and sold in the U.S. and Canada by Berlex.
Committed to developing novel therapeutics that address unmet medical needs, Berlex Laboratories, Inc. researches, develops, manufactures, and markets ethical pharmaceuticals in three strategic areas: Diagnostic Imaging, Female Healthcare, Therapeutics and Dermatology for life-threatening and chronic, disabling diseases. Berlex business divisions are located in Montville and Wayne, New Jersey, and in Richmond, California. For more information about the company please visit the web site: http://www.berlex.com. To learn about MS and Berlex-sponsored patient support programs, please visit http://www.betaseron.com or call MS Pathways at 800-788-1467.
Chiron Corporation, headquartered in Emeryville, California, is a leading biotechnology company that participates in three global healthcare markets: biopharmaceuticals, blood-testing and vaccines. The company is applying a broad and integrated scientific approach to the development of innovative products for preventing and treating cancer, infectious diseases, and cardiovascular diseases. This approach is supported by research strengths in recombinant proteins, genomics, small molecules, gene therapy, and vaccines. For more information, visit the company's website at http://www.chiron.com.
Contact: Joanne Marion, Director, Investor Relations, 973-276-2164,
or Richard Salem, Director, Corporate Communications, 973-276-2371, both
of Berlex Laboratories, Inc; or Joyce Lonergan, VP Corporate Development,
Investor Relations, Chiron Corporation, 510-923-3030