Ares-Serono Announces Frone Efficacy Data In MS

Ares-Serono has become the fourth company in recent weeks to release new data on a multiple sclerosis drug, in this case the company's Frone (native interferon beta) product (Marketletters passim). Six-month data from a Phase II trial of the drug reveal that it can achieve "a 67% reduction in the number of active lesions as measured in T1 and T21-weighted MRI scans."

These results come from an ongoing open-label study in Spain. Monthly MRI scans generated in the study are analysed by two independent external observers blinded to the patients' treatment. The trial involved 60 patients who were recruited into groups, receiving either 9 MIU of Serono's interferon beta by subcutaneous injection three times a week or no treatment. At the end of six months, the untreated group was switched to Frone following the same treatment schedule. Relapsing-remitting MS patients with an Expanded Disability Scoring System score of zero to five and a disease duration of one to 10 years were enrolled.

The clinical parameters at six months showed that the exacerbation rate in the interferon beta group was 1.24 compared to 2.0 in the control group (extrapolated to one year). 59% of the Frone-treated patients remained exacerbation-free during the treatment period compared to only 31% in the control group. Similarly, the proportion of patients with severe exacerbations was 14% and 38%, respectively. Overall, Frone was well-tolerated at the doses used for MS therapy, although 30% of patients experienced injection site reactions and 50% experienced mild, transient flu-like symptoms. Only one patient had to withdraw from Frone therapy.