Additional European Applications Expected To Follow
PLANTATION, Fla., Feb. 4 /PRNewswire-FirstCall/ -- Viragen, Inc.
(Amex: VRA) and its majority-owned subsidiary, Viragen International, Inc.
(OTC Bulletin Board: VGNI), today announced that an application has been filed
with the Swedish regulatory authorities seeking to expand the approval for
Multiferon(R) to include the first-line adjuvant treatment of high-risk
malignant melanoma, following dacarbazine (DTIC) after surgical removal of
tumors. This submission represents the initial step of the Company's plans to
seek broader European approvals for Multiferon(R).
"The use of alpha interferon may not be new in the treatment of melanoma,
but we believe that our Phase II/III study results differentiate our product
and demonstrate that low-dose, six-month treatment with Multiferon(R), our
unique human leukocyte-derived alpha interferon, represents a significant
advantage to physicians, payors and patients in terms of efficacy, cost and
safety," stated Charles A. Rice, Viragen's President and CEO.
Mr. Rice explained, "As opposed to conventional options that may be poorly
tolerated with longer treatment durations, physicians should benefit from
knowing that there is a therapeutic regimen that their patients are likely to
remain compliant with, resulting in a higher probability of success and fewer
patient drop-outs. Payors should certainly enjoy the lower expense and
treatment time associated with Multiferon(R) in this low-dose, six-month
regimen, instead of continuing high-dose recombinant interferon therapy for
extended months, and even years. And patients should realize safety benefits,
being far less likely to develop neutralizing antibodies to Multiferon(R)
therapy, which can inhibit efficacy."
Viragen's Executive Vice President of Operations, Mel Rothberg, commented
on how the Company's melanoma strategy may impact partnering activities,
"While we are monitoring a number of new products in the development pipeline
for the treatment of melanoma, we are not aware of data reported that
represents such an improvement over conventional therapies as does this
regimen of Multiferon(R). Related to partnering, we continue in discussions
with a number of candidate companies, including those who are interested in
marketing Multiferon(R) as the 'natural choice(TM)', not only in Europe, but
also in available territories in South America and Asia."
Viragen also reported that it intends to request a meeting with the FDA to
review its melanoma clinical trial and to discuss an outline for clinical work
that would be required to bring Multiferon(R) to the U.S. market.
About the Phase II/III Malignant Melanoma Study:
In a controlled, randomized, multi-center trial conducted in Germany, the
investigators evaluated the adjuvant sequential treatment of Malignant
Melanoma (Stage IIb, IIIa, IIIb; high risk) with 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.
The analysis confirmed a statistically significant increase in overall
survival for patients treated with adjuvant DTIC followed by Multiferon(R),
compared to patients with no adjuvant treatment.
In spite of the extremely promising outcome, it is ultimately the decision
of the appropriate regulatory authorities as to whether or not our application
will be granted.
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.
Decision Resources reports that the current worldwide melanoma
therapeutics market is estimated at $437 million and is expected to exceed
$1.1 billion worldwide by 2013.
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 Bulgaria,
Mexico and 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: Bulgaria, 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
dcalder@viragen.com
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