PLANTATION, Fla., May 8 /PRNewswire-FirstCall/ -- 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.
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 "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.
SOURCE Viragen, Inc.
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Related links:
http://www.viragen.com/
CONTACT:
Douglas Calder, Director of Communications of
Viragen, Inc., +1-954-233-8746, Fax, +1-954-233-1414,
dcalder@viragen.com
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