Genetronics Initiates Pancreatic Cancer Clinical Trial Using its MedPulser Tumor Ablation System.SAN DIEGO -- New Oncology Indication Exhibits Broad Applicability of Genetronics' Therapy for Treating Solid Tumors Genetronics Biomedical bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. Corporation (AMEX AMEX See: American Stock Exchange :GEB Geb or Keb In ancient Egyptian religion, the god of the earth and the physical support of the world. Geb and his sister Nut belonged to the second generation of deities at Heliopolis. ), a late stage developer of oncology and other therapies using electroporation electroporation (i·lekˈ·trō·p The cellular molecules DNA and RNA that act as coded instructions for the production of proteins and are copied for transmission of inherited traits. , announced today that it has initiated a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I to treat pancreatic cancer pancreatic cancer Malignant tumour of the pancreas. Risk factors include smoking, a diet high in fat, exposure to certain industrial products, and diseases such as diabetes and chronic pancreatitis. Pancreatic cancer is more common in men. using its MedPulser(R) Tumor Ablation System. The FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 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(R) electroporation therapy in conjunction with intralesionally-injected bleomycin bleomycin /ble·o·my·cin/ (ble-o-mi´sin) a polypeptide antibiotic mixture obtained from cultures of Streptomyces verticellus; used as the sulfate salt as an antineoplastic. ble·o·my·cin n. 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(R) 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 (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Genetronics. "This study will also exhibit the ability of our electrochemical electrochemical /elec·tro·chem·i·cal/ (-kem´i-k'l) pertaining to interaction or interconversion of chemical and electrical energies. e·lec·tro·chem·i·cal adj. 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 adenocarcinoma: see neoplasm. 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(R) 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 DNA: see nucleic acid. DNA or deoxyribonucleic acid One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes. 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 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 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. |
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