Multiferon(R) Shows Potent Activity In Preventing The Progression Of Malignant Melanoma; Study To Be Published

Main Category: Melanoma / Skin Cancer
Also Included In: Cancer / Oncology;  Clinical Trials / Drug Trials
Article Date: 09 May 2007 - 0:00 PDT

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Viragen, Inc. (AMEX: "VRA"; "VRA.U"; "VRA.WS") and Viragen International, Inc. (OTC BB: "VGNI") today announced results from a sponsored in vitro study conducted at Umea University in Sweden, which found that Multiferon(R) (multi- subtype, human alpha interferon) suppressed development of resistant human melanoma clones to a far greater degree than recombinant alpha interferon. The study has been accepted for publication in AntiCancer Research, International Journal of Cancer Research and Treatment.

The study, conducted by Professor Erik Lundgren, Head of Research at the Department of Molecular Biology, Umea University, was designed to compare Multiferon(R) and Intron(R) A (Interferon alpha-2b, recombinant) with respect to the abilities of each product to inhibit the development of interferon- resistant melanoma cells in vitro, in order to better understand the reason for melanoma treatment failures.

The Study:

Three human melanoma cell lines were grown at a range of different cell concentrations in the presence of graded doses of either Multiferon(R) or Intron(R) A. After four weeks, the number of melanoma cell colonies were assessed and their properties analyzed.

Results:

Long-term treatment with Multiferon(R) was found to result in substantially fewer interferon-resistant melanoma clones than treatment with Intron(R) A. When treated with the single-subtype, recombinant alpha interferon, not only were distinct colonies found, but scattered individual cells were also observed. In contrast, during short term treatment, there was no difference in potency between the two interferon types with respect to growth and survival.

Conclusion:

The results suggest that the mixture of six human alpha subtypes present in Multiferon(R) (a1 a2, a8, a10, a14, a21) provides distinct benefits versus other alpha interferon products in vitro with respect to reducing the number of resistant clones.

According to Professor Lundgren, "It is widely known that melanoma cells often develop resistance to recombinant alpha interferon therapies. We observed dramatically different outcomes when comparing Multiferon(R) against Intron(R) A in human melanoma cell lines in vitro, with Multiferon(R) clearly suppressing resistance development far more efficiently than Intron(R) A after four weeks of treatment. One possibility is that multiple subtypes of alpha interferon in Multiferon(R) are working synergistically to eradicate resistant cell clones. If Multiferon(R) is indeed suppressing the development of resistant melanoma clones, this effect may have played a role in improving overall survival in melanoma patients in Viragen's previously reported Phase II/III melanoma trial, published last year in Acta Oncologica."

In February 2006, Multiferon(R) was approved in Sweden for the first-line adjuvant treatment of high-risk malignant melanoma. Viragen is preparing to proceed with a European Union (EU) regulatory process for Multiferon(R), through a registration pathway called the Mutual Recognition Procedure (MRP). This procedure allows a single registration dossier to be filed for approval among a targeted group of EU countries via one application and review process.

Intron(R) A is registered trademark of Schering-Plough Corporation

About Malignant Melanoma:

Skin cancer is the most common type of cancer, accounting for more than 50% of all cancers. Melanoma accounts for approximately 4% of skin cancer cases, but causes 79% of skin cancer deaths. The American Cancer Society estimates that in 2006 there were 62,190 new cases of melanoma in the United States and about 7,910 people died of this disease.

About Multiferon(R):

Alpha interferon is produced by the human immune system and helps improve the body's natural resistance to disease.

Multiferon(R) differs from single-subtype recombinant alpha interferon drug products in that it contains a unique mixture of multiple subtypes of human interferon (a1, a2, a8, a10, a14, a21). It is believed that each subtype, some of which are glycosylated, employs a specific biological activity, but more importantly, the subtypes act synergistically to elicit an overall effect.

For prescription information, please visit: http://www.Multiferon.com

About Viragen, Inc.:

With international operations in the U.S., Scotland and Sweden, we are a bio-pharmaceutical company engaged in the research, development, manufacture and commercialization of therapeutic proteins for the treatment of cancers and viral diseases. Our product portfolio includes: Multiferon(R) (multi- subtype, human alpha interferon) which is uniquely positioned in valuable niche indications, such as high-risk malignant melanoma, and other select cancers and infectious diseases; VG102, a novel monoclonal antibody that binds selectively to an antigen that is significantly over-expressed on nearly all malignant tumors; and VG106, a novel cytokine targeting difficult-to-treat cancers. We are also pioneering the development of The OVA(TM) System with the renowned Roslin Institute, creators of "Dolly the Sheep", as a revolutionary manufacturing platform for the large-scale, efficient and economical production of human therapeutic proteins and antibodies, by expressing these products in the egg whites of transgenic hens.

The foregoing press announcement contains forward-looking statements that can be identified by such terminology such as "believes," "expects," "potential," "plans," "suggests," "may," "should," "could," "intends," 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 and/or commercial results could be affected by, among other things, uncertainties relating to clinical trials and product development; availability of future financing; unexpected regulatory delays or government regulation generally; the success of third- party marketing efforts; our ability to retain third-party distributors; our ability to obtain or maintain patent and other proprietary intellectual property protection; and competition in general. Forward-looking statements speak only as to the date they are made. The Company does not undertake to update forward-looking statements to reflect circumstances or events that occur after the date the forward-looking statements are made.

Viragen, Inc.
http://www.viragen.com