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Addition
of New Oncology Indication Significantly Expands Scope of
Planned
Product Launch
Genetronics Biomedical Corporation (Amex: GEB), a late stage developer
of
oncology
and other therapies using electroporation to deliver drugs and
nucleic
acids, announced today that the company has begun treating skin
cancers
in patients with primary and recurrent solid tumors requiring
potentially
disfiguring surgical treatment in a European pre-sales clinical
study
using its MedPulser(R) Electroporation Therapy System.
This pre-marketing Phase IV study is a multi-center, open label study
that
will measure clinical efficacy based on local tumor control through a
six
month post treatment period and assess local and systemic safety and
tolerance.
It will also evaluate pharmacoeconomic benefits including
reductions
in surgical and hospital costs. Documenting clinical and
pharmacoeconomic
benefits of the therapy in support of reimbursement,
creating
a reference and customer base among key opinion leaders,
establishing
centers of excellence to facilitate early sales, and generating
additional
safety and efficacy data to support regulatory submissions in
North America
will all support Genetronics'
marketing goals. This study,
which
is being managed by Quintiles Transnational Corporation, will treat
over
100 patients in a number of hospitals in
Europe
.
In a previous cutaneous cancer study performed by the H. Lee Moffitt
Cancer
Center
at The University of South
Florida, 130 of 146 tumors (89%)
demonstrated
a complete response to Genetronics' electroporation therapy. The
tumor
types included basal cell carcinoma, melanoma, and Kaposi's sarcoma. In
a
publication of this study (Heller et al., Cancer, Vol. (83), July 1,
1998),
the
authors concluded, "ECT (electrochemotherapy) was shown to be an
effective
local treatment for cutaneous malignancies. The results suggest
that
ECT may have a tissue-sparing effect and result in minimal
scarring."
Nonmelanoma skin cancers (NMSCs) are the most common of cancers.
Estimates
indicate that NMSCs affect more than 1 million people in the United
States
each year, almost as much as all other cancers combined, and 500,000
in
Europe
. Basal cell carcinomas (BCC)
account for about 75% to 80% of NMSCs,
with
the balance being primarily squamous cell carcinomas. NMSCs usually
develop
on chronically sun-exposed areas of the skin and about 80% of these
cancers
are estimated to occur in the head and neck region. The average
increase
of NMSC in white populations in
Europe
, the
United States
,
Canada
,
and
Australia
was 3% to 8% per year since
the 1960s.
About the MedPulser(R) Electroporation Therapy System
The
MedPulser(R) Electroporation Therapy System is designed to treat
solid
tumors while preserving the structure and function of surrounding
healthy
tissue. By applying a brief electric field to targeted tissue,
Genetronics'
electroporation therapy induces transient cell membrane pores
that
enable dramatically increased cellular uptake of a locally administered
therapeutic
agent. This agent is bleomycin, an approved drug that is highly
selective
in killing cancerous cells. The Company believes the therapy has
been
shown to be effective and safe for the local treatment of head and neck
cancers
and for cutaneous and subcutaneous cancers. Numerous pre-clinical and
clinical
studies have shown the MedPulser Electroporation Therapy System to
be
capable of treating virtually all tumor types.
The MedPulser has received the European CE Mark and Genetronics
anticipates
launching the product in
Europe
toward the end of 2005.
Genetronics
is conducting a multi-center pre-sales clinical trial in
Europe
to
measure quality of life and pharmacoeconomic outcomes when using the
MedPulser
in the treatment of newly-diagnosed primary and recurrent head and
neck
cancers. In the
U.S.
, Genetronics completed the
Special Protocol
Assessment
process with the Food and Drug Administration (FDA) and
subsequently
initiated two pivotal Phase III trials for recurrent and second
primary
squamous cell carcinomas of the head and neck. The FDA also granted
the
MedPulser System fast track designation.
More
information can be obtained at
www.genetronics.com.
(12/11/04) |