Novantrone (mitoxantrone for injection concentrate) is an intravenously delivered synthetic molecule indicated to reduce neurologic disability and frequency of relapses in patients with worsening RRMS, patients with secondary progressive multiple sclerosis, and patients with progressive-relapsing MS (but not primary-progressive MS).
History of Novantrone
Two major clinical trials tested the safety and efficacy of Novantrone in multiple sclerosis patients. Patients in the first study were diagnosed with secondary progressive or progressive relapsing MS. They were randomized into three groups: placebo (control), 5 mg/m² Novantrone, or 12 mg/m² Novantrone. Treatments were administered intravenously every three months over two years. Patients were also evaluated for side effects at the three-month follow-up. Any relapses were treated with high-dose methylprednisolone. A total of 149 patients completed the full two years of treatment.
Patients in the second study were diagnosed with secondary progressive or worsening RRMS with residual neurological deficit between relapses. After an initial screening period to identify patients who developed at least one new Gd-enhancing MRI lesion in two months, 42 patients were treated with a combination of methylprednisolone and Novantrone. Half were treated with an intravenous dose of 1g of methylprednisolone alone, and half were treated with an intravenous combination of approximately 12 mg/m² of Novantrone and 1g of methylprednisolone. Treatment lasted six months, and patients were evaluated monthly.
At the conclusion of these two studies, researchers identified fewer new lesions, fewer relapses, less neurological decline, and less physical decline in Novantrone-treated patients.
How Novantrone Works
Novantrone interacts with DNA. The molecule inserts itself within DNA strands, causing the DNA to break apart. This affects the proliferation of cells, specifically B-cell, T-cell, and macrophage cell proliferation. These are the key auto-reactive cells in RRMS, so preventing their proliferation reduces disease activity.
Novantrone also reduces the production of interferon gamma, tumor necrosis factor-alpha (TNF), and interleukin-2 (IL2), which are inflammatory proteins over-produced in MS patients. Reducing the inflammatory environment of the nervous system helps protect neurons from further damage.
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