Interferon beta treatment success for multiple sclerosis shown with MRI
Reata Pharmaceuticals, Inc. has announced that RTA 402 has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic cancer. RTA 402 is currently being studied in a Phase 1/2 trial in patients with pancreatic cancer, and is also in Phase 2 development for chronic kidney disease.
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Regular magnetic resonance imaging (MRI) evaluations show that only about half of patients with multiple sclerosis achieve and sustain a response to treatment with interferon beta over three years, according to a study posted online today that will appear in the January 2009 print issue of Archives of Neurology.
Before they develop symptoms of a relapse, patients with multiple sclerosis (MS) develop contrast-enhancing brain lesions that are visible on MRI, according to background information in the article. Worsening of the disease is presumed to follow these relapses. “Many clinical studies have demonstrated the ability of interferon beta to reduce contrast-enhancing lesions,” the authors write. “However, little is known regarding the heterogeneity of the MRI response profiles between patients or within an individual patient over time.”
Annie W. Chiu, B.S., and colleagues at the National Institute of Neurological Disorders and Stroke, Bethesda, Md., assessed 15 patients with MS who underwent monthly MRIs and clinical examinations during a six-month pretreatment phase and a 36-month treatment phase. During treatment, patients receive injections of 250 micrograms of interferon beta under the skin every other day.
Eight patients (53.3 percent) achieved a 60 percent reduction in the number of lesions at each six-month period and were therefore classified as responders. Of the seven non-responders, three (20 percent) initially experienced a reduction in the total number of lesions but then did not experience further reductions, two (13.3 percent) never reached the 60 percent level of reduction and two (13.3 percent) failed to respond during the first six months but reached and maintained an optimal reduction in lesions of 60 percent or more thereafter. Three patients in the responder group and all seven patients in the non-responder group experienced at least one clinical exacerbation during the treatment phase.
“To our knowledge, our descriptive study provides for the first time a detailed long-term analysis of MRI patterns of patients undergoing long-term interferon beta-1b therapy,” the authors conclude. “The results show that on close monthly MRI inspection, approximately half of the patients fail therapy from an MRI perspective.”
“Also, we show that an additional small proportion of patients may not be necessarily recognized as MRI non-responders during the first semester [six months] of therapy, and frequent radiological monitoring is advised during the first year of therapy. Multiple MRIs, beyond the first six months of therapy, also disclose a small proportion of patients with a delayed but eventually sustained response to interferon beta and provide compelling information regarding the clinical outcome of patients during the course of a longer trial.”
Bristol-Myers Squibb and ZymoGenetics, Inc. have announced a global collaboration for PEG-Interferon lambda, a novel type 3 interferon currently in Phase Ib development for the treatment of Hepatitis C, and its related development program. Under the terms of the collaboration, Bristol-Myers Squibb agreed to pay ZymoGenetics an upfront cash payment of $85 million for the
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Giving interferon to heart failure patients with evidence of a chronic viral infection safely eliminated two viruses from their systems and reduced levels of a third virus. Additionally, there were trends toward improved cardiac function and quality of life, but these did not reach significance at 24 weeks, researchers reported at the American Heart
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Scientists at UT Southwestern Medical Center have determined that the immune-system protein interferon plays a key role in “teaching” the immune system how to fight off repeated infections of the same virus. The findings, available online and in the Dec. 15 issue of the Journal of Immunology, have potential application in the development of more
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On December 11, 2008, the Joint Advisory Committees of the U.S. Food and Drug Administration (FDA) - including the Drug Safety & Risk Management Advisory Committee, the Pediatric Advisory Committee, and the Pulmonary-Allergy Drugs Advisory Committee - completed a review of the benefits and risks of asthma medications containing long-acting beta-agonists (LABAs). The committees concluded
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A new method of characterizing breast lesions found during an MRI exam could result in fewer biopsies of benign tumors with the benefits of reduced pain and expense for patients and providers, according to a paper that will be presented (Sunday, Nov. 30) at the annual meeting of the Radiological Society of North America (RSNA).
Full Post: New method could help reduce breast-lesion biopsies