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Inovio Initiates Recurrent Breast Cancer Clinical Trial Using Its Selective Electrochemical Tumor Ablation Therapy

Posted on: Thursday, 20 October 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 it has initiated a Phase I clinical trial to treat locally recurrent cancer after a mastectomy or partial mastectomy using its Selective Electrochemical Tumor Ablation (SECTA) therapy. This study is designed to demonstrate that Inovio's novel SECTA therapy, which provides unique selectivity in killing cancerous cells, can preserve surrounding healthy tissue when treating solid tumors while providing equivalency to surgery in terms of local tumor control. As an alternative to mastectomy for managing recurrences after prior breast conserving therapy, SECTA could potentially provide important quality of life benefits to breast cancer patients.

This FDA-approved study is a multi-center, open label, single treatment arm trial and may enroll up to 24 patients with locally recurrent or metastatic in-breast carcinoma after partial mastectomy (lumptectomy) or cutaneous or sub-cutaneous recurrent or metastatic carcinoma of the breast or chest wall following mastectomy. The primary endpoint is to assess the safety profile of Inovio's electroporation-based SECTA therapy in conjunction with intralesionally-injected bleomycin. Secondary endpoints include an assessment of histopathology and objective tumor response through 24 weeks.

"I believe that our Selective Electrochemical Tumor Ablation therapy has tremendous benefits to offer the many women who must endure not only the general trauma of having cancer but the potential emotional effects of complete or partial surgical removal of a breast," stated Avtar Dhillon, MD, president and CEO of Inovio. "We are pleased to initiate this study, which marks the sixth clinical trial that Inovio has planned to display the broad utility and large market potential of our SECTA therapy. With the progress of our clinical trials, which include head & neck, skin, and pancreatic cancers, we look forward in 2006 to significant data flow with respect to the efficacy and important quality of life benefits of our novel therapy."

About Breast Cancer

Breast cancer is the second most common form of cancer and the second leading cause of cancer deaths among women in the United States. In 2004, the estimated new cases of breast cancer (women only) in the United States were 215,990, and 40,110 women died of the disease. Worldwide there were an estimated 1,151,298 new incidences and 410,712 deaths in 2002.

Local-regional treatment of primary breast carcinomas involves mastectomy (removal of the entire breast, with or without axillary lymph node dissection) or breast-conserving therapy (e.g. lumpectomy, breast irradiation). Adjuvant radiation therapy and systemic chemotherapy are performed relative to the extent of regional nodal involvement and risk categories. Approximately 10% to 20% of these patients will have locally recurrent disease in the breast between one and nine years after mastectomy or breast conservation surgery plus radiation therapy. Up to 32% of patients with in-breast local recurrence treated with mastectomy will develop a chest wall recurrence. Five-year survival among patients undergoing mastectomy or conservative surgery has been shown to be similar (52%-86% and 81%-85%, respectively).

Recurrent breast cancer is often responsive to therapy and patients with local-regional in-breast or chest wall recurrences may become long-term survivors with appropriate therapy. For patients with local tumor recurrence following mastectomy or conservative surgery, a local treatment of solid tumors that spares normal tissue may be a preferable method for the local management of recurrent breast carcinoma while preserving tissue function and appearance.

About the Selective Electrochemical Tumor Ablation System

Inovio's Selective Electrochemical Tumor Ablation (SECTA) therapy consists of its MedPulser(R) electroporation device, which significantly enhances local cellular uptake of useful biopharmaceuticals, in conjunction with a designated chemotherapeutic agent and is designed 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 developing human therapeutic applications of electroporation, with 60 U.S. and 140 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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