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Genetronics Commences European Pre-Sale Skin Cancer Study Using Its MedPulser(R) Electroporation Therapy System

Posted on: Tuesday, 9 November 2004, 06:00 CST

SAN DIEGO, Nov. 9 /PRNewswire-FirstCall/ -- Genetronics Biomedical Corporation , 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.

"The initiation of this study is just another step towards our goal of successfully launching our MedPulser Electroporation Therapy System in Europe and also highlights the broad applicability of this product for different types of cancer," stated Avtar Dhillon, MD, Genetronics' president and CEO. "We have selected highly respected physicians and clinics to participate in this study and believe this study will rapidly provide additional validating data of our therapy's efficacy and cost benefits in the treatment of solid tumors of the skin."

"We are looking to improve the treatment outcome for patients afflicted with skin cancer who would otherwise be subjected to disfiguring surgery," stated Dr. Claus Garbe, the Lead Principal Investigator and Head of the Dermatological Oncology Section in the Department of Dermatology at the University of Tubingen in Germany. "There is a significant unmet clinical need for an alternative to surgery that selectively destroys cancer cells without harming normal healthy tissue, and I am therefore excited about Genetronics' MedPulser(R) Electroporation Therapy System."

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."

About Skin Cancers

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.

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(R) Electroporation Therapy System, through pre-sales studies for head and neck as well as skin cancers in Europe, where it has CE Mark accreditation, and a U.S. Phase III pivotal study for recurrent head and neck cancer. Merck, Vical, Chiron, the US Navy and other partners are also employing Genetronics' electroporation technology, which facilitates local delivery of drugs and nucleic acids, in their development of novel DNA vaccines and gene therapies. Genetronics is a leader in the application of electroporation for human therapies, with over 240 patents worldwide that are issued, allowed or pending. More information can be obtained at http://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 3-month period ended June 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. The American Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.

Genetronics Biomedical Corporation

CONTACT: investors, Bernie Hertel of Genetronics Biomedical Corporation,+1-858-410-3101; or media, Susan Neath of Atkins + Associates,+1-858-527-3486, for Genetronics Biomedical Corporation

Web site: http://www.genetronics.com/

Source: PRNewswire-FirstCall

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