SAN DIEGO, June 7 /PRNewswire-FirstCall/ -- Genetronics Biomedical Corporation , a leader in electroporation-enhanced delivery of drugs, DNA vaccines, and gene therapies intended to treat cancer, infectious diseases, and other medical conditions, has been granted a fast track designation by the U.S. Food and Drug Administration for its MedPulser Electroporation System clinical development program for patients with head and neck cancer. The fast track designation is intended to facilitate development and expedite the review of new therapies that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs so that an approved product can reach the market expeditiously.
Genetronics is currently conducting two Phase III pivotal studies comparing the MedPulser System in combination with the cancer drug, bleomycin, versus surgical resection in patients with recurrent or second primary squamous cell carcinoma head and neck cancer. The studies are designed to evaluate the MedPulser System's ability to preserve organ function (e.g. ability to eat, swallow, and speak) while achieving comparable local tumor control and survival rates relative to surgical resection of the tumor.
"Head and neck cancer is a devastating disease with notable unmet treatment needs. The fast track designation of our MedPulser Electroporation Therapy System confirms the need for effective new therapies, which we believe our therapy represents for patients with head and neck cancer -- as well as other high-incidence solid tumors," said Avtar Dhillon, M.D., President & CEO.
About Head and Neck Cancer
Cancer of the head and neck is a progressively debilitating and life-threatening disease. Despite significant advances in treating other types of cancer, the morbidity and mortality resulting from head and neck cancer remains unacceptably high. The primary therapies, surgery and radiation therapy, are expensive, disfiguring (involving removal of healthy tissue), and frequently disabling (e.g. affecting the ability to speak). Head and neck cancer that returns after initial treatment is usually fatal.
There are approximately 40,000 cases of head and neck cancer reported annually in the United States and over 80,000 cases reported in Europe.
The MedPulser(R) Electroporation Therapy System
The MedPulser(R) Electroporation Therapy System is designed to treat solid tumors by locally applying a defined electric field to target cells, inducing transient cell membrane pores that allow significantly increased uptake of previously administered therapeutic agents into the cell interior. The therapy selectively kills cancer cells while preserving surrounding healthy tissue, resulting in significant improvements to quality of life by preserving organ function as well as appearance.
About Genetronics Biomedical Corporation
Genetronics Biomedical Corporation is a late stage biomedical company primarily focused on building an oncology franchise based on its proprietary electroporation therapy (EPT). EPT enhances the local delivery of drugs, DNA vaccines, and genes. The company is moving its lead product, MedPulser(R), through pre-marketing studies for head and neck cancer in Europe, where it has received CE Mark accreditation, and a Phase III study for recurrent head and neck cancer in the US. EPT can be used to enhance the delivery of other molecules, and the company is developing therapies using DNA vaccines and gene therapies with various biotechnology and pharmaceutical companies. Current partnerships and collaborations include Merck, Chiron, the US Navy and Vical. Genetronics is a leader in electroporation, with over 240 patents 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 ending December 31, 2003, and the Form 10-Q for the 3-month period ending March 31, 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 do not accept responsibility for the adequacy or accuracy of this release.
Genetronics Biomedical Corporation