H. Lee Moffitt Cancer Center & Research Institute And Inovio Biomedical Corporation Announce Positive Results From Pioneering Human Study Of Plasmid DNA Delivery Using Electroporation
"Electroporation-mediated gene delivery using Inovio's MedPulser® DNA Electroporation System was well tolerated, reproducible and without any dose limiting toxicity. With 15 patients treated so far, we can say that this method permits efficient expression of plasmid DNA, with demonstrable immune responses," stated Dr. Adil Daud, principal investigator of the study and an oncologist at Moffitt and the University of South Florida, College of Medicine. "Dose escalation is continuing as we attempt to define dose limiting toxicity."
In this Phase I open-label study, plasmid DNA encoding a cytokine, interleukin-12 (IL-12), is delivered directly to tumors in patients with malignant melanoma through electroporation using the MedPulser® DNA Electroporation System. Inovio's technology enables the entry and significant uptake of the plasmid DNA into the tumor cells, ultimately leading to cytokine production. The intent of this procedure is to induce an immune response that will eliminate the cancer.
Richard Heller, PhD, a University of South Florida professor of molecular medicine and Dr. Daud's co-researcher on the study, presented at the ASGT meeting interim results on safety and tolerability as well as immune cell infiltration observed in tumor masses of treated subjects. A prior pre-clinical study conducted by Heller and his team found that the electroporation of IL-12 plasmid resulted in an 80 percent complete regression of a very aggressive melanoma in a mouse model and that this response correlated with IL-12 expression in the tumor. Considering this past observation, the present data, which shows significant levels of interleukin-12 protein in the treated tumor mass together with infiltration of immune cells, may be indicative of clinical responses achievable in future clinical studies.
"We are encouraged that this first set of clinical data from what we believe is the first human study of plasmid DNA delivered using electroporation is exhibiting safety and tolerability of the MedPulser® DNA Electroporation System. This is a significant milestone and we are very pleased with the progress of our collaboration with the H. Lee Moffitt Cancer Center, which is focused on developing new treatments for melanoma, one of the deadliest and hardest to treat forms of cancer," stated Avtar Dhillon, MD, president and CEO of Inovio. "These results should further encourage other developers of DNA vaccines and gene-based treatments of protein-deficiency diseases to consider Inovio's proprietary DNA electroporation technology as an alternative to viral and other delivery methods."
Background on the MedPulser® DNA Electroporation System
Inovio's MedPulser® DNA Electroporation System applies brief electrical pulses to tissue to create permeability in cell membranes in order to dramatically increase cellular uptake and gene expression of locally injected DNA plasmids. Non-human primate studies have shown that electroporation and the MedPulser DNA Electroporation System can be safely used to increase the immune response to DNA plasmids by 100 to 1000 fold.
About H. Lee Moffitt Cancer Center & Research Institute
In 2001, the National Cancer Institute awarded Moffitt the status of a Comprehensive Cancer Center in recognition of its excellence in research and contributions to clinical trials, prevention and cancer control. Additionally, Moffitt is a member of the National Comprehensive Cancer Network, a prestigious alliance of the country's leading cancer centers, and is listed in the U.S. News & World Report as one of the top cancer hospitals in America. Moffitt's sole mission is to contribute to the prevention and cure of cancer.
About Inovio Biomedical Corporation
Inovio Biomedical Corporation is a late stage biomedical company focused on commercializing its proprietary Selective Electrochemical Tumor Ablation (SECTA) therapy. SECTA is designed to target a significant unmet clinical need: a local treatment for solid tumors, with selective killing of cancer cells while preserving surrounding healthy tissue. Inovio is moving its lead product, the MedPulser®, 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 head and neck cancer, and Phase I trials for pancreatic and breast cancer. Merck, Vical, University of Southampton, and H. Lee Moffitt Cancer Center are using Inovio's gene delivery technology in clinical studies of novel DNA therapeutics delivered using electroporation. Inovio is a leader in developing human therapeutic applications of electroporation, with the industry's most extensive patent portfolio covering in vivo electroporation. More information is available at www.inovio.com.
This press release contains certain forward-looking statements relating to our plans to develop our electroporation drug and gene delivery technology and to maximize shareholder value. Actual events or results may differ from our expectations as a result of a number of factors, including the uncertainties inherent in clinical trials and product development programs (including, but not limited to, the fact that interim results from the Phase I study referenced in this release may vary significantly from final results of this and other ongoing clinical studies and referenced preclinical results involving a small number of mice may not be indicative of results achievable from testing in humans), evaluation of potential opportunities, the level of corporate expenditures, the assessment of our technology by potential corporate partners, capital market conditions, and other factors set forth in the our Annual Report on Form 10-K for the year ended December 31, 2005, our Form 10-Q for the three months ended March 31, 2006, and other regulatory filings. There can be no assurance that any product in our 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.
Contact: Inovio Biomedical Corporation Bernie Hertel, 858-410-3101 Investor Relations or Porter Novelli Life Sciences Susan Neath, 858-527-3486 Inovio Media Relations or Moffitt Cancer Center Jean C. Johnson, 813-975-7896 Media Relations
Source: Inovio Biomedical Corporation