Switzerland-based Ares-Serono Group said data from Phase II/IIItrials of its recombinant interferon beta product, Rebif, for treatmentof multiple sclerosis showed the drug was able to reduce attacks inrelapsing-remitting patients by 60 percent.

The results, reported Wednesday, were from a one-year, open studyin Italy where 68 patients received one of two doses of therecombinant interferon beta. The clinical endpoint involvedevaluating reduction in number and size of disease lesions on thebrain.

Lesions were monitored by gadolinium-enhanced magnetic resonanceimaging. Ares-Serono investigators said the data showed the numberof existing lesions declined 55 percent and the size of others wasreduced 66 percent. The results also indicated that the number of newlesions declined 65 percent and for those that did emerge, theirgrowth rate was slowed by 67 percent.

In addition, the company reported a 60 percent reduction in the rateof exacerbations experienced by the relapsing-remitting multiplesclerosis patients, leading the investigators to conclude that there is acorrelation between the number of lesions and the rate of attacks.

Gina Cella, an Ares-Serono spokeswoman, said the study is one ofsix ongoing Phase II/III trials involving its recombinant and naturalforms of interferon beta.

She said the company will not seek approval of the drug in the U.S.for relapsing-remitting multiple sclerosis because Cambridge, Mass.-based Biogen Inc. has orphan drug status for that indication with itsrecombinant interferon beta product.

She said Ares-Serono plans to pursue other multiple sclerosisindications in the U.S. for Rebif. The company, she said, expects tocomplete studies in 1997 for chronic progressive and early onsetmultiple sclerosis. However, the trials are being conducted in Europe.

Ares-Serono has filed for approval of recombinant interferon beta inItaly for multiple sclerosis. In Spain the company is seeking approvalof its natural interferon beta, called Frone, for multiple sclerosis.Frone already is on the market in about 13 countries outside the U.S.for a variety of other indications, such as hepatitis B and hepatitis C.

Biogen, in May, filed a new drug application (NDA) with the FDAfor market approval of its interferon beta, called Avonex. It also isseeking approval in Europe. This month, Teva PharmaceuticalIndustries Inc., of Jerusalem, filed an NDA for its multiple sclerosisdrug, Copaxone, which is a co-polymer 1 with a different mechanismof action from the beta interferon products.

Chiron Corp., of Emeryville, Calif., has a multiple sclerosis drug onthe market in the U.S. It's beta interferon product, called Betaseron,was approved by the FDA in 1993.

Competition among the multiple sclerosis products, particularlybetween Biogen's and Chiron's drugs, is expected to be fierce if theFDA approves Avonex and Copaxone. The beta interferon drugs andTeva's co-polymer 1 are not cures, but they target the underlyingmechanisms of the disease.

Stephen Reingold, of the National Multiple Sclerosis Society in NewYork, said Betaseron "is a hard drug to take and is expensive," so thepossibility of alternative treatments is welcome news for multiplesclerosis patients.

Reingold, who is the society's vice president of research and medicalprograms, said he was not familiar with the data reported from theAres-Serono's study.

Robert LeBoyer, an analyst with Brown Brothers Harriman in NewYork, said Betaseron costs about $8,000 per patient per year. IfAvonex and Copaxone are approved, he said Betaseron probably willremain the drug of choice by those who are already using it andbenefiting from it. He expects new patients to lean toward Avonexwhile those in the early stages of the disease are more likely to tryCopaxone than the other two products.

Multiple sclerosis is a neurological disease caused by damage to themyelin sheath, which insulates nerve fibers that transmit electricalimpulses.

-- Charles Craig

(c) 1997 American Health Consultants. All rights reserved.