This investigator-sponsored Phase I clinical trial, underway at the Moffitt Cancer Center in Tampa, Florida, was designed to test safety and tolerability of direct intratumoral delivery of plasmid-based IL-12 using Inovio's electroporation technology. Interim results from 24 subjects are being presented at the Third International Conference on DNA Vaccines in Malaga, Spain, by Dr. Richard Heller of the University of South Florida and Moffitt Cancer Center.
Results from the study demonstrated significant and dose-dependant increases in IL-12 protein expression in the tumors of subjects administered plasmid-based IL-12 with electroporation. These data confirm gene expression in the treated subjects. In addition, initial evaluation determined that nearly 70 percent of the 78 treated tumors (two to four melanoma tumors per subject) showed an objective local clinical response to the treatment when biopsied after initiation of the therapy.
Dr. Avtar Dhillon, Inovio's CEO, said, "This pioneering clinical study is providing compelling evidence of safety and tolerability as well as proof of principle for DNA delivery and expression using electroporation to deliver DNA into human subjects - without need of a viral or lipid vector. We look forward to further clinical study results to potentially establish Inovio's DNA delivery technology as the delivery method of choice for localized administration of DNA treatments."
Enrollment of this study has been completed and further results are expected in the second half of 2007.
About Inovio's Immunotherapy Products
DNA-based immunotherapy products have the potential to by-pass inherent scientific obstacles of conventional vaccines that prevent their development for cancer and chronic infectious diseases such as HIV and hepatitis C. Pre-clinical data has indicated the potential ability of Inovio's technologies to safely and effectively deliver and significantly enhance the potency of such immunotherapies.
Inovio's DNA-based immunotherapy products consist of DNA plasmids and the Elgen and MedPulser DNA delivery systems. DNA plasmids are designed to express antigens that can induce an immune response specific to a cancer or infectious disease-causing organism. These plasmids are created synthetically and readily manufactured using well-established bacterial fermentation and purification technology. After a plasmid is delivered into muscle or tumor cells, production of the desired antigens may then induce a preventive or therapeutic immune response against the targeted disease. Inovio's advanced electroporation devices facilitate delivery and expression of such immunotherapies and have been shown in primate studies to boost antibody and T-cell immune response by orders of magnitude over DNA plasmid alone, suggesting the potential to provide better protection from complex infectious diseases such as HIV and hepatitis C as well as cancers such as prostate and breast cancers.
Inovio is poised to deliver advanced DNA-based immunotherapies, devices and know-how in this rapidly advancing field. The company is actively licensing its technology to pharmaceutical and biotechnology companies and supporting early stage clinical studies arising from its own research efforts or through academic collaborations.
About USF Health at the University of South Florida
USF Health is a partnership of the USF's colleges of medicine, nursing, and public health, dedicated to the promise of creating new models of health and health care. USF is one of the nation's top 63 public research universities as designated by the Carnegie Foundation for the Advancement of Teaching.
About H. Lee Moffitt Cancer Center & Research Institute
Located in Tampa on the University of South Florida campus, H. Lee Moffitt Cancer Center & Research Institute (www.moffitt.org) is the only Florida-based cancer center with the NCI designation as a Comprehensive Cancer Center for its excellence in research and contributions to clinical trials, prevention and cancer control. Moffitt's sole mission is to contribute to the prevention and cure of cancer.
About Inovio Biomedical Corporation
Inovio Biomedical (AMEX:INO) is focused on developing multiple DNA-based immunotherapies and commercializing its Selective Electrochemical Tumor Ablation (SECTA) therapy. Inovio is a leader in developing human applications of electroporation, which uses brief, controlled electrical pulses to increase cellular uptake of a useful biopharmaceutical and, in the case of DNA-based treatments, levels of gene expression. Inovio's immunotherapy partners include Merck, Wyeth, Vical, University of Southampton, Moffitt Cancer Center, and the U.S. Army, with four DNA-based immunotherapies in Phase I clinical studies. The SECTA therapy for locally treating solid tumors is designed to selectively kill cancerous cells and minimize cosmetic or functional detriments often caused by surgical removal of predominantly healthy tissue typically treated around a tumor. SECTA is advancing through pre-marketing studies for head & neck and skin cancers in Europe, where it has CE Mark accreditation, a U.S. Phase III pivotal study for head and nec k cancer, and a Phase I/II trial for breast cancer. Inovio's technology is protected by an 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. 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 pre-clinical results referenced in this release may not be indicative of results achievable from testing in humans), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of Inovio's technology as a delivery mechanism, the availability or potential availability of alternative therapies or treatments for the conditions targeted by Inovio or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that Inovio and its collaborators hope to develop, evaluation of potential opportunities, issues involving patents and whether they or licenses to them will provide Inovio with meaningful protection from others using the covered technologies, whether such proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity and whether Inovio can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of our technology by potential corporate or other partners or collaborators, capital market conditions, and other factors set forth in the our Annual Report on Form 10-K for the year ended December 31, 2006 and other regulatory filings. There can be no assurance that any product in our product pipeline will be succe ssfully developed or manufactured, or that final results of clinical studies will be supportive of regulatory approvals required to market licensed products.
Inovio Biomedical Corporation
Bernie Hertel, 858-410-3101
Jeff Richardson, 805-491-8313