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Metastatic Melanoma Treatment Results Using Inovio's Selective Electrochemical Tumor Ablation Therapy Published in Melanoma Research

Posted on: Monday, 19 September 2005, 06:00 CDT

Inovio Biomedical Corporation (AMEX:INO), a late stage developer of oncology and other therapies using electroporation to deliver drugs and nucleic acids, announced today that a scientific article presenting study results of the treatment of metastatic melanoma using Inovio's Selective Electrochemical Tumor Ablation (SECTA) therapy were published in Melanoma Research, 2005, Vol 15, No 1. The results of the study, which achieved a 72% complete response rate and 78% objective response rate in 18 study lesions, were documented in an article entitled, "Treatment of metastatic melanoma using electroporation therapy with bleomycin (electrochemotherapy)." The article concluded that electrochemical tumor ablation may be advantageous in terms of local tissue preservation, outpatient treatment feasibility, improved quality of life, reduced cost, and response in certain settings in which conventional therapy, such as surgery, has failed. It noted that the technique is potentially useful for patients with secondary and, possibly, primary tumors. This was the first publication to present data resulting from a multi-site, international phase II clinical study of different types of skin cancer.

Nineteen patients with metastatic melanoma were enrolled in a phase II, randomized, open-label study using Inovio's selective electrochemical tumor ablation therapy, which uses intralesional bleomycin in conjunction with electroporation. Endpoints measured included tumor response, time to healing, and local and systemic complications. Patients were treated on an out-patient basis. They were followed up for a minimum of 12 weeks after treatment.

"Selective electrochemical tumor ablation can be performed on an outpatient basis and provides a relatively non-invasive and well-tolerated therapeutic option for patients with troublesome cutaneous and subcutaneous melanoma metastases," said Dr. John Thompson, co-author of the article. He is Professor and Head, Department of Surgery (Melanoma and Surgical Oncology), University of Sydney, and Executive Director, Sydney Melanoma Unit, Royal Prince Alfred Hospital, Sydney, Australia. Dr. Thompson is a member of Inovio's Scientific Advisory Board.

"Controlling local and regional melanoma recurrences typically requires multiple surgeries that can be extremely debilitating. A simple ablation therapy that may be applied without anesthesia on an outpatient basis would be of great value to patients. These study results, achieved by renowned physicians at the world's largest melanoma treatment center, show the potential of our Selective Electrochemical Tumor Ablation Therapy to meet this clinical need," said Avtar Dhillon, MD, Inovio's president and CEO.

The study was conducted at the Sydney Melanoma Unit, Royal Prince Alfred Hospital, Camperdown and Newcastle Melanoma Unit, Newcastle Mater Hospital, Newcastle, in Australia. It was funded in part by Genetronics Inc., Inovio's operating subsidiary, and the Melanoma Foundation of the University of Sydney. The article was co-authored by Christopher M. Byrne, John F. Thompson, Heather Johnston, Peter Hersey, Michael J. Quinn, T. Michael Hughes and William H. McCarthy.

About the MedPulser(R) Selective Electrochemical Tumor Ablation System

Inovio's Selective Electrochemical Tumor Ablation (SECTA) therapy is designed to use electroporation, which significantly enhances local cellular uptake of useful biopharmaceuticals, in conjunction with a designated chemotherapeutic agent to destroy malignant tissue without harming normal healthy tissue. The therapy is intended to provide physicians with an easy-to-use alternative to surgery to provide local tumor control. Surgery is a clinical tool frequently used to remove solid tumors, but can result in disfigurement and function loss. Inovio's SECTA therapy is highly selective in killing cancerous cells and can minimize or avoid these outcomes, and in doing so may improve patient quality of life and reduce treatment and hospitalization costs.

About Inovio Biomedical Corporation

Inovio Biomedical Corporation is a late stage biomedical company focused on building an oncology franchise based on its proprietary electrochemical tumor ablation system. The therapy targets a significant unmet clinical need: the selective killing of cancer cells and local ablation of solid tumors while preserving healthy tissue. Inovio is moving its lead product, the MedPulser(R), through pre-marketing studies for head and neck cancer and skin cancers in Europe, where it has CE Mark accreditation, a U.S. Phase III pivotal study for recurrent head and neck cancer, and a Phase I pancreatic cancer trial. Vical, University of Southampton, and H. Lee Moffitt Cancer Center are using Inovio's gene delivery technology in the first-ever clinical studies of novel DNA vaccines delivered using electroporation, which enhances local delivery and cellular uptake of useful biopharmaceuticals, and Merck is a development partner for the gene delivery technology. Inovio is a leader in electroporation, with 57 U.S. and 125 corresponding foreign issued patents, plus numerous pending patents in the U.S. and abroad. More information can be obtained at www.inovio.com.

This press release contains certain forward-looking statements relating to Inovio's plans to develop its electroporation drug and gene delivery technology and to maximize shareholder value. Actual events or results may differ from Inovio's 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 Inovio's technology by potential corporate partners, capital market conditions, and other factors set forth in Inovio's Annual Report on Form 10-K for the year ended December 31, 2004, and its Quarterly Report on Form 10-Q for the three months ended June 30, 2005, and other filings with the Securities and Exchange Commission. There can be no assurance that any product in the Inovio product pipeline will be successfully developed or manufactured, or that final results of clinical studies will be supportive of regulatory approvals required to market licensed products.

Source: Business Wire

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