Genetronics Biomedical Corporation

March 01, 2005 03:00 ET

Genetronics Initiates Pancreatic Cancer Clinical Trial Using its MedPulser Tumor Ablation System


NEWS RELEASE TRANSMITTED BY CCNMatthews

FOR: GENETRONICS BIOMEDICAL CORPORATION

AMEX SYMBOL: GEB

MARCH 1, 2005 - 03:00 ET

Genetronics Initiates Pancreatic Cancer Clinical Trial
Using its MedPulser Tumor Ablation System

SAN DIEGO--(CCNMatthews - Mar 1, 2005) -

New Oncology Indication Exhibits Broad Applicability of Genetronics'
Therapy for Treating Solid Tumors

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 it has initiated a Phase I clinical
trial to treat pancreatic cancer using its MedPulser® Tumor Ablation
System. The FDA has granted Genetronics orphan designation for this
indication.

The primary endpoint of this FDA-approved study is to determine the
safety profile of the MedPulser® electroporation therapy in
conjunction with intralesionally-injected bleomycin for the treatment of
unresectable or incurable locally advanced pancreatic cancer. The
secondary endpoints are to assess objective tumor response, patient
pain, and weight loss over 24 weeks following electroporation therapy.
Genetronics aims to complete enrollment of up to 12 patients by the end
of 2005.

"There is typically tremendous pain associated with pancreatic cancer
and a lack of good treatment options to control this pain, leading to
very poor quality of life in the final stages of the disease. We believe
the Medpulser® Tumor Ablation System may provide an important new
approach to alleviate and control this pain and enhance patients'
quality of life," stated Avtar Dhillon, President and CEO of
Genetronics. "This study will also exhibit the ability of our
electrochemical ablation technique to treat solid tumors inside the body
cavity, which may significantly expand the number of solid tumor
applications and greatly enhance the market potential of the MedPulser
system."

The Office of Orphan Product Developments has granted Genetronics orphan
designation for the treatment of pancreatic cancer. Upon successfully
securing marketing approval from the FDA for this indication,
Genetronics could then also secure orphan drug status, providing U.S.
marketing exclusivity for seven years and certain tax benefits.

Genetronics' electroporation therapy using bleomycin has been shown to
have anti-tumor activity against resistant human pancreatic
adenocarcinoma cells in previous in vitro and in vivo studies.

About Pancreatic Cancer

Over the past half-century, the incidence of pancreatic carcinoma has
increased dramatically in the U.S., Europe, and Japan. In 2004, an
estimated 31,860 new cases of pancreas cancer were expected to be
diagnosed in the U.S. and an estimated 31,270 deaths were expected to
occur. The five-year relative survival rate is about 4% for all disease
stages combined, with a five-year survival rate of only 17% survival for
local disease.

Surgical resection (removal of all or part of an organ, tissue, or
structure) is the only option to cure a local pancreatic malignancy.
However, only 10% to 20% of patients with pancreatic cancer are
candidates for surgical resection. Current standard therapy of advanced
disease where resection is not viable involves the use of chemotherapy
to provide some clinical benefit from pain, loss of performance, or
weight loss. However, pain is still the most disturbing symptom of
pancreatic cancer, affecting 30% to 40% of the patients by the time of
death.

About Genetronics Biomedical Corporation

Genetronics Biomedical Corporation is a late stage biomedical company
focused on building an oncology franchise based on its proprietary
electroporation therapy. The therapy targets a significant unmet
clinical need: the selective killing of cancer cells and local ablation
of solid tumors while preserving healthy tissue. The company is moving
its lead product, the MedPulser® Tumor Ablation System, through
European pre-marketing studies for head and neck cancer and skin cancer,
where it has CE Mark accreditation, and a U.S. Phase III pivotal study
for recurrent head and neck cancer. Merck, Vical, Chiron, the U.S. Navy,
and other partners are employing Genetronics' electroporation
technology, which enhances local delivery and cellular uptake of useful
biopharmaceuticals, in their development of novel DNA vaccines and gene
therapies. Genetronics is a leader in electroporation, with over 240
patents worldwide that are issued, allowed or pending. More information
can be obtained at www.genetronics.com.

This press release contains certain forward-looking statements relating
to Genetronics' plans to develop its electroporation drug and gene
delivery technology and to maximize shareholder value. Actual events or
results may differ from Genetronics' expectations as a result of a
number of factors, including the uncertainties inherent in clinical
trials and product development programs, evaluation of potential
opportunities, the level of corporate expenditures, the assessment of
Genetronics' technology by potential corporate partners, and capital
market conditions, and others set forth in the Genetronics Annual
Report, on Form 10-K for the 12-month period ended December 31, 2003,
and the Form 10-Q for the 9-month period ended September 30, 2004, and
other regulatory filings. There can be no assurance that any product in
the Genetronics product pipeline will be successfully developed or
manufactured, or that final results of human pilot studies or clinical
studies will be supportive of regulatory approvals required to market
licensed products.

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Contact Information

  • FOR FURTHER INFORMATION PLEASE CONTACT:
    Genetronics Biomedical Corporation
    Investor Relations
    Bernie Hertel, 858-410-3101
    or
    Atkins + Associates
    Media Relations
    Rebecca Wong, 858-527-3495