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28th June 2001

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Viragen approved to start MS clinical trials
Plantation, Fla.

VIRAGEN Inc and Viragen (Europe) Ltd jointly announced that the Medicines Control Agency, the governmental body that regulates therapeutic drugs in the United Kingdom, has approved Viragen’s Application for its natural alpha interferon, Omniferon, to commence human clinical trials for the treatment of multiple sclerosis.

Omniferon is currently in phase II clinical trials in Europe for hepatitis C. The multiple sclerosis clinical trials are expected to begin later this year. Additional evaluations are ongoing to determine Omniferon’s potential for the treatment of genital herpes and many cancers. Dr Peng Lee Yap, Viragen’s Chief Medical Director, said, ‘‘The approval of our Application enables us to start the administration of Omniferon to multiple sclerosis (MS) patients as part of Viragen’s development plans to gain marketing authorization for the routine treatment of MS with Omniferon. The phase II (a) clinical trial will focus on demonstrating the safety and tolerance of different doses of Omniferon in such patients.’’

Viragen’s chairman and CEO, Gerald Smith, stated, ‘‘This approval marks an important milestone which targets a second billion dollar market for the use of Omniferon.

PRNewswire

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