More MS news articles for June 2001

Viragen Approved to Start MS Clinical Trials

http://www.viragen.com/pressreleases/2001/virpr062101.htm

Thursday, June 21st, 2001

PLANTATION, FLORIDA – June 21, 2001 – Viragen, Inc. (AMEX: “VRA”) and Viragen (Europe) Ltd. (OTC BB: VERP) today 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, Mr. Gerald Smith, stated, “This approval marks an important milestone which targets a second billion dollar market for the use of Omniferon. We believe that our natural interferon may fill unmet needs for patients who have failed to respond to previous standard treatments.”

Omniferon is a highly purified multi-subtype natural interferon alpha derived from human white blood cells. Interferons are proteins produced by the white blood cells that modulate the human immune system and are one of the body’s most basic and effective defenses against a wide spectrum of diseases. The global sales of interferons, approved to treat many diseases, are growing at a double-digit rate and are approaching $3 billion annually.

According to Viragen’s Chief Operating Officer, Dr. Magnus Nicolson, “The most widely used drug regimen to treat multiple sclerosis is recombinant Beta interferon which is a Type 1 interferon. These Beta interferons are genetically engineered and there is a growing body of evidence showing that a significant percentage of patients develop antibodies to recombinant Beta interferon. This may limit their efficacy and potentially cause adverse side-effects. Since our natural alpha interferon, which is also a Type 1 interferon, is derived from human white blood cells, we believe that it should be less immunogenic and possibly better tolerated. These safety studies will determine how well natural alpha interferon is tolerated by MS patients. Omniferon may represent a potent alternative in the treatment of multiple sclerosis patients, particularly those with antibody responses to recombinant Type 1 interferons.”

Multiple sclerosis is a chronic, often disabling disease of the central nervous system. It is estimated there are approximately 350,000 patients in Europe suffering from MS, with a similar number in the U.S.

Viragen is scheduled to make a presentation describing Viragen’s projects at the American Stock Exchange Online Conference, a live Webcast hosted by Mr. Gerald Smith, on Thursday, June 21, 2001 at 3:00 p.m. (EST). All interested parties may access the live Webcast by visiting http://www.viragen.com, http://www.amex.com or http://www.streetfusion.com. Participants should log onto one of the host sites at least fifteen minutes before the event to install the needed software.

About Viragen, Inc.:

Viragen, Inc. researches, develops and manufactures drugs including natural human interferon and human monoclonal antibodies for the treatment of many life-threatening diseases such as hepatitis C, multiple sclerosis and cancer. In addition to developing a portfolio of proprietary drugs, Viragen is engaged in the development of Avian Transgenic Production Technology which is designed to deliver an efficient, cost-effective alternative to the biopharmaceutical industry for the large-scale production of protein-based drugs.

Viragen holds the worldwide exclusive license to commercialize Avian (bird) Transgenic Production Technology granted by the Roslin Institute in Scotland, renowned for their creation of “Dolly the Sheep”. The Avian Project is designed to produce protein-based drugs, including monoclonal antibodies to fight cancer, inside the eggs of transgenic chickens. Avian Technology promises a much faster, cost-effective and virtually unlimited production process marked by the chicken’s prolific egg laying capabilities.

The foregoing press release contains forward-looking statements that can be identified by such terminology such as “expects”, “potential”, “suggests”, “may”, “will”, or similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. In particular, management’s expectations regarding future research development results could be affected by, among other things, uncertainties relating to clinical trials and product development; unexpected regulatory delays or government regulation generally; the Company’s ability to obtain or maintain patent and other proprietary intellectual property protection; and competition in general.
 

Corporate Contacts:

Viragen, Inc.:

Mel Rothberg, Executive Vice President
Phone: (954) 233-8746; Fax: (954) 233-8743
E-mail: mrothberg@viragen.com

Douglas Calder, Director of Communications
Phone: (954) 233-8746; Fax: (954) 233-1414
Email:  dcalder@viragen.com