SAN DIEGO, and TAMPA, Fla., Jan. 13 /PRNewswire-FirstCall/ -- Genetronics Biomedical Corp. and the H. Lee Moffitt Cancer Center announced today the initiation of a Phase I clinical trial using Genetronics' MedPulser(R) System to deliver plasmid DNA to tumors with the aim of treating malignant melanoma. The trial is sponsored by the H. Lee Moffitt Cancer Center and will measure the safety of Genetronics' electroporation system to deliver plasmid DNA into tumor cells to mount an immune response.
In this Phase I open-label study, plasmid DNA encoding a cytokine is delivered directly to tumors in patients with malignant melanoma through electroporation using the MedPulser(R) System. This technology enables the entry and significant uptake of plasmid DNA into the tumor cells, ultimately leading to cytokine production. The intent of this procedure is to induce an immune response that will eliminate the cancer.
"We look forward to working with the world-renowned H. Lee Moffitt Cancer Center to treat one of the deadliest and hardest to treat forms of cancer, melanoma, using our MedPulser(R) System," stated Avtar Dhillon, MD, president and CEO of Genetronics. "We believe this milestone -- the first use of the MedPulser(R) System, and electroporation, to deliver plasmid DNA in a human clinical trial -- represents an important accomplishment for Genetronics and for electroporation technology. It highlights the vital role we are playing to develop novel therapies for diseases with significant unmet clinical needs."
Dr. Richard Heller, investigator at the H. Lee Moffitt Cancer Center and the University of South Florida, College of Medicine, stated, "Preclinical data with cytokine DNA therapy in animals showed significant tumor regression, even in distal untreated tumors, and we are pleased to see this technology move into clinical testing. We see much promise in this new application of Genetronics' electroporation technology to potentially induce a systemic anti-cancer immune response in patients in a manner that has reduced side effects relative to traditional cancer treatment."
Background on the MedPulser(R) Electroporation Therapy System
The MedPulser(R) Electroporation Therapy System significantly enhances local cellular uptake of useful biopharmaceuticals. Genetronics is commercializing a cancer therapy using bleomycin, an approved anti-cancer drug, with the goal of reducing side effects and costs compared to existing treatment methods.
The MedPulser(R) has received the European CE Mark and Genetronics anticipates launching the product in Europe in 2005. Genetronics is conducting multi-center, pre-marketing, observational studies in Europe to study the Genetronics MedPulser(R) in the treatment of newly diagnosed, primary and recurrent, head and neck cancers, as well as skin cancers. These studies are measuring quality of life and pharmacoeconomic outcomes. In the U.S., Genetronics completed a Special Protocol Assessment with the Food and Drug Administration (FDA), which approved clinical studies measuring quality of life as the primary endpoint. The Company is conducting two pivotal Phase 3 trials for recurrent and second primary squamous cell carcinomas of the head and neck. The FDA granted fast track status for these trials.
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-marketing studies for head and neck cancer and skin cancer 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 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 http://www.genetronics.com/.
About the H. Lee Moffitt Cancer Center
In 2001, the National Cancer Institute awarded Moffitt the status of a Comprehensive Cancer Center in recognition of its excellence in research and contributions to clinical trials, prevention and cancer control. Additionally, Moffitt is a member of the National Comprehensive Cancer Network, a prestigious alliance of the country's leading cancer centers, and is listed in the U.S. News & World Report as one of the top cancer hospitals in America. Moffitt's sole mission is to contribute to the prevention and cure of cancer.
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 year ended December 31, 2003, and the Form 10-Q for the three-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 Corp.