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(reg) 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(reg) 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(reg) 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(reg) 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 genetronics .
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.
CONTACT:
Media Relations
Rebecca Wong
Phone: (858) 527-3495
Investor Relations
Bernie Hertel
Atkins + Associates
Phone: (858) 410-3101