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Skin cancer treatment by electroporation
 
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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)