PLANTATION, Fla., June 20 /PRNewswire-FirstCall/ -- Viragen, Inc.
(Amex: VRA) and its majority-owned subsidiary, Viragen International, Inc.
(OTC Bulletin Board: VGNI), today announced that Acta Oncologica, a leading
European journal in clinical oncology, has published an article profiling
the use of Multiferon(R) for the adjuvant treatment of high-risk (Stages
IIb-III) malignant melanoma patients (Volume 45, Number 4, June 2006,
pp.389-399).
The article, entitled "Long-term survival benefit after adjuvant
treatment of cutaneous melanoma with dacarbazine and low dose natural
interferon alpha (Multiferon(R)): A controlled, randomized multi-center
trial," reports positive results for a category of melanoma patients for
whom prognosis is generally poor. The article concludes that the
dacarbazine/Multiferon(R) regimen "was found to be well tolerated and to
give beneficial effects on survival that were particularly significant in
patients with deep and/or metastasizing stages of melanoma, but still free
from distant metastases."
The article's publication follows the February approval of
Multiferon(R) for sale in Sweden for the first-line adjuvant treatment of
high-risk malignant melanoma following dacarbazine (DTIC) after surgical
removal of tumors.
Viragen's President and CEO, Charles A. Rice, said that the Company was
"very optimistic" about its current ongoing negotiations for a European
Union licensee, while cautioning that there can be no guarantee of securing
any agreement.
"Our partnering discussions continue at an accelerated pace, and we are
encouraged at the level of interest, particularly with respect to the
melanoma indication," Mr. Rice said. "Additionally, at the 6th Annual
International Conference on the Adjuvant Therapy of Malignant Melanoma last
week in Stockholm, we met with a cadre of international melanoma experts
who will participate in our next semi-global clinical trial with
Multiferon(R). Their comments and suggestions will be included in our final
trial design criteria, and we will move forward with this post-marketing
study as quickly as possible."
Acta Oncologica Article Abstract:
In a prospective, controlled, randomised, multicentre study 252
patients with totally resected cutaneous melanoma (248 in stage II-III and
4 in stage IV) were either treated with two doses of dacarbazine (DTIC)
followed by a 6- month treatment with 3 MU thrice weekly of highly purified
natural interferon- alpha (n=128; arm A) or received no adjuvant treatment
(n=124; arm B). Treatment was well tolerated. After a median follow-up of
8.5 years ITT analysis showed that the difference in survival was
statistically significant with respect to melanoma-related deaths (HR=0.65,
CI=0.46-0.97, p=0.022) and close to significance with respect to overall
survival (HR 0.71, CI 0.49-1.00, p=0.052). The risk reduction of
melanoma-associated death, calculated by Cox proportional hazards
modelling, after adjusting for identified predictive variables, was almost
50% (p=0.002). The overall efficacy of the treatment appeared to be mainly
attributable to effects observed in patients with deep and/or metastasizing
tumours (HR 0.60, CI 0.40-0.90, p=0.013).
"We received a tremendous amount of interest regarding these results at
the Stockholm conference," stated Orjan Norberg, Managing Director of
ViraNative AB, the Viragen International subsidiary that manufactures
Multiferon(R) in Umea, Sweden.
"Based on meetings with prominent, leading melanoma physicians, there
is continuing dissatisfaction with the use of recombinant alpha interferon
for the adjuvant treatment of melanoma. This is not surprising since
recombinant, single subtype alpha interferon is often poorly tolerated,
while demonstrating no improvement in overall survival. It is our mission
to demonstrate that all alpha interferons are not alike, and that our
impressive results in melanoma treatment are directly attributable to the
unique attributes of Multiferon(R)."
Mr. Norberg explained, "Multiferon(R) is comprised of six alpha
interferon subtypes, which we believe influence antiproliferative and
immunological effects that are quantitatively and qualitatively different
from recombinant interferon products. Most importantly, we are convinced
that our Multiferon(R) regimen offers a safe and effective treatment option
with a significant reduction in total treatment time and cost."
About Acta Oncologica:
Published eight times per year, Acta Oncologica is one of the leading
journals in clinical oncology and related disciplines, and accepts articles
within all fields of clinical cancer research from applied basic research
to cancer nursing and psychological aspects of cancer. It is the official
journal of the five Nordic oncological societies, and the members of the
editorial committee represent these societies.
About Viragen, Inc.:
With global operations in the U.S., Scotland and Sweden, Viragen is a
biotechnology company engaged in the research, development, manufacture and
commercialization of pharmaceutical proteins for the treatment of viral
diseases and cancers. Our product portfolio includes: Multiferon(R) (multi-
subtype, natural human alpha interferon) targeting a broad range of
infectious and malignant diseases; and humanized monoclonal antibodies
targeting specific antigens over-expressed on many types of cancers. We are
also pioneering the development of Avian Transgenic Technology, with the
renowned Roslin Institute, as a revolutionary manufacturing platform for
the large-scale, efficient and economical production of human therapeutic
proteins and antibodies.
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 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, +1-954-233-8746, or fax, +1-954-233-1414, or
dcalder@viragen.com
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