Genetronics Initiates Pancreatic Cancer Clinical Trial Using its MedPulser(reg) Tumor Ablation System

Main Category: Pancreatic Cancer
Also Included In: Medical Devices / Diagnostics
Article Date: 03 Mar 2005 - 4:00 PDT

email to a friend   printer friendly   opinions  

New Oncology Indication Exhibits Broad Applicability of Genetronics' Therapy for Treating Solid Tumors -

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 it has initiated a Phase I clinical trial to treat pancreatic cancer using its MedPulser(reg) Tumor Ablation System. The FDA 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(reg) electroporation therapy in conjunction with intralesionally-injected bleomycin 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(reg) 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 of Genetronics. "This study will also exhibit the ability of our electrochemical 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 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(reg) 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 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 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.

CONTACT:

Media Relations
Rebecca Wong
Phone: (858) 527-3495

Investor Relations
Bernie Hertel
Atkins + Associates
Phone: (858) 410-3101

• Additional
• References
• Citations