Safety and Efficacy of MLC601 in Iranian Patients after Stroke: A Double-Blind, Placebo-Controlled Clinical Trial.

Objective. To investigate the safety and efficacy of MLC601 (NeuroAid) as a traditional Chinese medicine on motor recovery after ischemic stroke. Methods. This study was a double-blind, placebo-controlled clinical trial on 150 patients with a recent (less than 3 month) ischemic stroke. All patients were given either MLC601 (100 patients) or placebo (50 patients), 4 capsules 3 times a day, as an add-on to standard stroke treatment for 3 months. Results. Sex, age, elapsed time from stroke onset, and risk factors in the treatment group were not significantly different from placebo group at baseline (P > .05). Repeated measures analysis showed that Fugl-Meyer assessment was significantly higher in the treatment group during 12 weeks after stroke (P < .001). Good tolerability to treatment was shown, and adverse events were mild and transient. Conclusion. MLC601 showed better motor recovery than placebo and was safe on top of standard ischemic stroke medications especially in the severe and moderate cases.

Biosimilars: opinion of an expert panel in the Middle East.

BACKGROUND: Several biotechnology-derived drugs are reaching the end of their patent lives. As a result, so-called biosimilar products are in development, and a few have already gained approval in Europe and other countries such as the USA. Biosimilars, unlike generic versions of conventional drugs, are not identical to their reference product, and their production is complex and sensitive to even slight changes in the manufacturing and storage process. Therefore, the registration of these products requires more stringent evaluation than that for conventional generics. METHODS AND SCOPE: A consensus group of experts from the Near and Middle East discussed the currently available guidelines for registration of biosimilars--including those produced by the European Medicines Agency (EMEA)--and their application in this region. To inform this report, a literature search was also conducted on PubMed in January 2008, using the search terms 'biosimilar' and 'follow-on biologic'. This paper provides an overview of the issues in the development and registration of biosimilars, a description of the EMEA guidelines and the recommendations of the consensus group for the registration of biosimilars in the Middle East. FINDINGS: Because of the complex nature of biosimilars and their potential immunogenicity, these products cannot undergo the abbreviated approval process used for generic agents. Instead demonstration of their quality, safety and efficacy, in comparison with their reference biological product, is required. CONCLUSIONS: The consensus group recommended the implementation of the EMEA guidelines as the basis of Regional guidelines for the registration of biosimilars in the Near and Middle East. Registration would, therefore, require demonstration of the robustness of the manufacturing process and quality-control methods, the comparability of pharmacokinetics, pharmacodynamics, efficacy and safety between the biosimilar and reference product and plans for post-marketing surveillance of the long-term risks and immunogenicity of new biosimilars.

Effect of early interferon beta-1a therapy on conversion to multiple sclerosis in Iranian patients with a first demyelinating event.

BACKGROUND: A new treatment approach to multiple sclerosis (MS) is the initiation of interferon therapy in the early phase of the disease when a patient presents with clinically isolated syndrome. AIMS OF THE STUDY: The goal of this study was to assess the effect of early treatment on the risk of conversion to clinically definite MS in Iranian patients. METHODS: Eligible patients had presented with a first episode of neurological dysfunction suggesting MS within the previous 3 months and had abnormal brain magnetic resonance imaging (MRI). Patients were randomly assigned to receive intramuscular interferon beta 1a 30 mug or placebo once a week for 3 years. RESULTS: Of the 217 patients randomized, 202 patients completed the study; 104 received Avonex and 98 received placebo. Fewer patients converted to clinically definite multiple sclerosis in the treated group than in the placebo group during the study (36.6% vs 58.2%, P < 0.003). The number of active T2-weighted MRI lesions was significantly lower in the treated group. CONCLUSIONS: The results of our study, which are consistent with those from western studies, show that treatment at an early stage of MS delays conversion to definite MS and has positive effects on MRI outcomes.

Treatment of early onset multiple sclerosis with suboptimal dose of interferon beta-1a.

BACKGROUND: Patients with early onset multiple sclerosis may develop disability at a younger age than adults. There are several reports about safety of beta interferons in childhood and juvenile MS with different doses. OBJECTIVES: To determine safety and efficacy of substandard dose of intramuscular interferon beta-1a in a prospective randomized trial in patients with multiple sclerosis under the age of 16. METHODS: Sixteen patients were divided into two groups randomly. The first group was treated with intramuscular interferon beta-1a 15 micrograms once a week and the second group received no disease-modifying therapy. RESULTS: The patients were followed for four years. There was no significant side effect and none of the treated patients discontinued the drug. There were significant differences between two groups regarding relapse rates (p = 0.04), disability progression (p = 0.01), and new T2 lesions (p = 0.006). CONCLUSION: Treatment with interferon beta-1a is well tolerated for a long period of time and may be effective in substandard doses in early onset multiple sclerosis.

The changes in the transmission functioning of the ulnar nerve in a high power magnetic field.

INTRODUCTION: The present study aims at exploring the changes in the functioning of the ulnar nerve in a high power magnetic field. METHODS: 12 volunteers with a healthy peripheral nervous system participated in the study. The ulnar nerve was selected from the upper organs as the site for study. The functioning of both the sensory and motor parts of the ulnar nerve in normal conditions was electromyographically tested. Then, using the same setting, the functioning of the nerve was electromyographically tested within a high power magnetic field (0.2 Tesla). With regard to the sensory function, the distal latency and the amplitude were examined. With regard to the motor section, the duration, amplitude of the evoked potentials, and latency from two sites--distal and proximal--were examined. These results of the two readings, taken in normal condition and in a high power magnetic field, as well as the motor neural conduction velocity, were compared. RESULTS: The statistical analyses indicated that the changes in both the distal latency and amplitude of the sensory part of the ulnar nerve were significant. However, the changes in the motor function of the nerve were not significant.