• 11/27/2005
  • San Diego, CA
  • press release
  • Medical News Today (www.medicalnewstoday.com)

Inovio Biomedical Corporation announced today that the European Journal of Surgical Oncology published an article, entitled “The role of intratumour therapy with electroporation and bleomycin in the management of advanced squamous cell carcinoma of the head and neck.” Co-authors of the article were Dr. David Bloom, now at the Department of Otolaryngology/ Head and Neck Surgery, Portsmouth Naval Hospital, Portsmouth, Virginia and Dr. Paul Goldfarb, Consulting Medical Director at Inovio Biomedical and Clinical Professor of Surgery at University of California, San Diego, California.

The article reported the safety and efficacy of Inovio’s Selective Electrochemical Tumor Ablation therapy, which uses electroporation in conjunction with bleomycin, in patients with head and neck advanced squamous cell carcinoma (HNSCC). Two open-label, multicenter, single-arm Phase II studies enrolled 62 patients with 86 squamous cell carcinoma tumors of the head and neck. Twenty-five patients were treated with bleomycin alone. Fifty-four patients (17 initially treated with bleomycin alone) were treated with electroporation and bleomycin therapy.

The local control rate of treatment for patients with recurrent HNSCC, consisting of surgery, radiation therapy and/or systemic chemotherapy, ranges between 10% and 20%. Thus, there is a need for alternative approaches.

In this trial, 57% of patients had an objective response with either a partial or complete response to electroporation with bleomycin. Electroporation therapy in combination with bleomycin demonstrated a significantly (p<0.001) greater number of patients showing an objective response to the therapy when compared to bleomycin alone, which resulted in a 4% objective response rate with no complete responses. The authors observed that the overall 30% survival rate at one year was consistent with the overall survival rate of patients with advanced stage HNSCC. The adverse event profile of intratumour bleomycin with electroporation treatment differed greatly from systemic bleomycin and other current chemotherapeutic agents used in HNSCC, with fewer systemic side effects than other means of administering bleomycin. Little surrounding destruction of tissue, compared to surgery, and few side effects make this therapy favorable for local control of disease.

“For patients who have failed prior therapy or have lesions in locations where surgical removal would be highly morbid, this therapy may provide an alternative approach,” said Dr. Goldfarb, the corresponding author. “If survival outcomes for different modalities are the same, the one with the better individual quality of life and decreased cost to society will become increasingly more important.”

“Publishing compelling data on our Selective Electrochemical Tumor Ablation therapy in yet another respected medical journal validates the importance of this system,” said Avtar Dhillon, MD, president and CEO of Inovio. “As we continue to work with more physicians and treat more patients, we look forward to the release of more data and advancing the commercialization process of this novel treatment.”

About Inovio’s Selective Electrochemical Tumor Ablation Therapy

Inovio’s Selective Electrochemical Tumor Ablation (SECTA) therapy consists of its MedPulserR 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, while potentially improving patient quality of life and reducing 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 MedPulserR, 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.