To print: Select File and then Print from your browser's menu --------------------------------------------------------------------------------------- Title: Novantrone Helps Delay Progression Of Disability In MS Patients URL: http://www.pslgroup.com/dg/AE74E.htm Doctor's Guide September 10, 1998
STOCKHOLM, SWEDEN -- Sept. 10, 1998 -- Researchers report that in preliminary results of a Phase III clinical trial, Immunex Corp.'s Novantrone(R) (mitoxantrone for injection concentrate) had a statistically significant impact on relapse rate and disability progression in patients with progressive multiple sclerosis (MS). These results were presented September 10th at the 14th congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS). Magnetic resonance imaging (MRI) data were also reported that corroborated the clinical findings. Novantrone was administered by short, IV infusion once every three months in this trial. Other treatments currently approved for MS require a subcutaneous or intramuscular self-injection on a daily or weekly basis. Multiple sclerosis is a highly debilitating illness that afflicts more than 300,000 Americans and more than one million people world-wide. This autoimmune disease attacks the central nervous system. The nerve fibres of the brain and spinal cord are insulated by a fatty substance called myelin, which helps conduct the flow of nerve impulses to and from the brain. But in people with MS, myelin is damaged, causing scar tissue, or sclerosis, that can distort or even block messages from the brain. This can result in a variety of symptoms that range from numbness in the limbs to complete paralysis. Novantrone is currently marketed to treat pain in patients with advanced hormone-refractory prostate cancer in combination with corticosteroids and for initial therapy of acute nonlymphocytic leukemia. It is not approved for use in MS patients. The Phase III, multicentre, placebo-controlled, randomised, observer-blind trial in 194 patients with progressive MS assessed the effects of Novantrone on disease progression. The study investigators compared two doses of Novantrone -- 12 mg/m2 and 5 mg/m2 -- with placebo and administered each treatment intravenously once every three months for two years. There was a statistically significant difference in the duration of time from initiation of treatment to the first severe MS attack, defined as the occurrence of a new symptom or the worsening of an existing symptom that requires treatment with corticosteroids, the most commonly used medication for controlling such episodes. The median time to first relapse was not reached after 24 months for both of the Novantrone doses and was 15 months for the placebo group. The difference in annual relapse rates was also significant, with a rate of 21 percent in the Novantrone 12 mg/m2 dose group compared to 60 percent for placebo. The relapse rate was 36 percent for the 5 mg/m2 dose. The percentage of patients who had confirmed treatment failure was seven percent for the 12 mg/m2 dosage, nine percent for the 5 mg/m2 dosage and 19 percent for placebo. The study investigators also used MRI in a subgroup of 110 patients at 12 and 24 months. The MRIs detected almost no additional lesions (scar tissue), an objective indicator of disease progression, in either the 5 or 12 mg/m2 Novantrone groups. In the placebo group, however, the MRI found a continuous increase in lesions at 12 and 24 months. There was a significant decrease in gadolinium-enhanced lesions in the 12mg/m2 group as compared to the placebo group. Investigators also reported that patients receiving Novantrone had an improvement of their neurologic function as measured by the Expanded Disability Status Scale (EDSS), the standard clinical rating scale used to evaluate disability progression in MS clinical trials. The EDSS measures disability based on the level of neurologic impairment. The EDSS rates a patient's level of function from zero (normal neurological exam) to 10 (death due to MS), with every half-point increase on the scale representing a progressive deterioration of ability. Mean change from baseline in EDSS score was -0.13 for patients receiving the 12 mg/m2 dose and -0.23 for the 5 mg/m2 dose compared to +0.23 for placebo. In addition, patients who received Novantrone had less deterioration of their mobility based on scores from the Ambulatory Index (AI), another measure of patient symptoms and disease progression. The AI rates a patient's mobility from zero (asymptomatic or fully active) to nine (restricted to wheelchair and unable to transfer independently). The mean change in score for Novantrone doses was +0.30 for the 12 mg/m2 dose and +0.41 for the 5 mg/m2 dose compared to +0.77 for placebo. Overall, treatment with Novantrone resulted in generally manageable side effects in this trial. The most frequently reported side effects were neutropenia (a reduced number of white blood cells), infection and alopecia (hair loss), which occurred in 11, 10 and five percent of the patients respectively. Related Links: Novantrone, Immunex Corp. --------------------------------------------------------------------------------------------- Copyright © 1999 P\S\L Consulting Group Inc. All rights reserved. Republication or redistribution of P\S\L content is expressly prohibited without the prior written consent of P\S\L. 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