PLANTATION, Fla., Oct. 5 /PRNewswire-FirstCall/ -- Viragen, Inc.
(Amex: VRA) and its majority-owned subsidiary, Viragen International, Inc.
(OTC Bulletin Board: VGNI), today announced the results from a 7-year follow-
up to a Phase II/III clinical study that evaluated the use of Multiferon(R),
natural human alpha interferon, for the treatment of malignant melanoma after
surgical removal of all tumor masses compared to surgery alone. The analysis
confirmed a statistically significant increase in overall survival for
patients treated with adjuvant dacarbazine (DTIC) followed by Multiferon(R),
compared to patients with no adjuvant treatment. The study data will serve as
the basis for an application that Viragen intends to file in Sweden to seek
expanded approval for Multiferon(R) to include the first-line adjuvant
treatment of high-risk malignant melanoma.
After a 7-year follow-up, the results showed an actual 51.3% overall
survival in high-risk patients treated with short-term DTIC, followed by
Multiferon(R) as adjuvant low-dose treatment for 6 months versus 30.3% overall
survival among patients who underwent surgery only (p=0.0077).
A follow-up beyond 7 years was obtained in most patients and 9-year
follow-up results showed an estimated 50.9% overall survival in the treated
population versus 23.5% in the control group. This suggests that a
significant survival benefit is sustained beyond 7 years.
"We intend to submit an application for registration with the Swedish
regulatory authorities for this new indication this year, which if approved,
could provide us with the opportunity to proceed with Mutual Recognition
Procedure (MRP) in the European Union (EU)," stated Viragen's President & CEO,
Mr. Charles A. Rice. "This study is of paramount importance as part of our
strategy to expand approvals for Multiferon(R) into major global markets, as
well as enhance our ability to attract key strategic partners."
About the Phase II/III Malignant Melanoma Study:
In a controlled, randomized, multi-center trial conducted in Germany, the
study evaluated the adjuvant sequential treatment of Malignant Melanoma (Stage
IIb, IIIa, IIIb; high risk) with dacarbazine (DTIC) followed by Multiferon(R)
(Highly purified, multi-subtype, natural human alpha interferon) versus
untreated controls, in patients who underwent complete surgical removal of all
tumor masses. The study was followed up for a minimum of 7 years in each
individual patient.
In spite of the extremely promising outcome, it is ultimately the decision
of the appropriate regulatory authorities as to whether or not the data is
accepted for the basis of an approval.
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. About 132,000 people worldwide
are diagnosed with melanoma each year, and more than 37,000 die from the
disease annually. According to Decision Resources, current pharmaceutical
therapies are extremely toxic and ineffective in the majority of patients.
Any emerging therapy that can bring modest improvements in overall survival
and tolerability will revolutionize the treatment of malignant melanoma.
Research and Markets reports that the worldwide melanoma therapeutics
market is estimated at $265 million in 2004 and is expected to exceed
$630 million worldwide by 2009.
About Alpha Interferon:
The majority of alpha interferons that are marketed are single-subtype
recombinant interferons. Therapy resistance is not unusual with recombinant
interferons with a significant percentage of patients failing to respond. In
some instances, recombinant interferon is rejected by the patient's immune
system, possibly the result of the formation of neutralizing antibodies which
may lead to a loss of clinical efficacy. Also, many patients cannot tolerate
the adverse side effects sometimes associated with recombinant therapy,
especially when applied in such high doses as they are approved for melanoma
treatment.
About Multiferon(R):
Multiferon(R) is a highly purified, multi-subtype, natural human alpha
interferon derived from human white blood cells and is approved in Sweden for
the second-line treatment of any and all diseases in which patients show an
initial response to recombinant alpha interferon followed by treatment
failure, possibly due to the formation of neutralizing antibodies.
Multiferon(R) is also approved for sale in the following countries for the
treatment of a range of viral and malignant diseases: Czech Republic, Egypt,
Hong Kong, Indonesia, Mexico, Myanmar, South Africa and Thailand. Work is
ongoing to expand the approved indications in these countries. Regulatory
approval activities are also underway in a number of other European, South
American, Middle East and Far East territories.
About Viragen, Inc.:
Viragen is a biotechnology company specializing in the research,
development and commercialization of natural and recombinant protein-based
drugs designed to treat a broad range of viral and malignant diseases. These
protein-based drugs include natural human alpha interferon, monoclonal
antibodies and a peptide drug. Viragen's strategy also includes the
development of Avian Transgenic Technology as a biomanufacturing platform for
the large-scale, cost-effective production of therapeutic proteins.
Viragen is publicly traded on the American Stock Exchange (VRA).
Viragen's majority owned subsidiary, Viragen International, Inc., is publicly
traded on the Over-The-Counter Bulletin Board (VGNI). Viragen's key partners
and licensors include: Roslin Institute, Memorial Sloan-Kettering Cancer
Center, Cancer Research UK, University of Nottingham (U.K.), University of
Miami, America's Blood Centers and the German Red Cross.
For more information, please visit: http://www.Viragen.com
Viragen, Inc. Corporate Contact:
Douglas Calder, Director of Communications
Phone: (954) 233-8746; Fax: (954) 233-1414 E-mail: dcalder@viragen.com
The foregoing press announcement contains forward-looking statements that
can be identified by such terminology such as "expect," "potential,"
"suggests," "may," "should," "could" 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 Company's 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.
SOURCE Viragen, Inc.
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Related links:
http://www.viragen.com
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CONTACT:
Douglas Calder, Director of Communications,
Viragen, Inc., +1-954-233-8746, or fax, +1-954-233-1414, or
e-mail, dcalder@viragen.com
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