SAN DIEGO (PRWEB) March 11, 2008
Dr. Adil Daud, Assistant Professor of Medicine & Oncology at the Moffitt Cancer Center and principal investigator of this clinical study, said, "We are pleased to report that this novel electroporation-based DNA immunotherapy was safe and tolerable. Furthermore, despite starting from nominal dose levels and without reaching dose-limiting toxicity, this therapy achieved evidence of durable local and systemic tumor regression. This study suggests that electroporation-mediated plasmid delivery is a powerful new tool for effective gene transfer, with implications for the clinical arena, and further clinical evaluation of this therapy is warranted."
Dr. Richard Heller, of the University of South Florida and Moffitt Cancer Center and Co-Principal Investigator on the study, presented the data at the DNA Vaccines Forum 2008 in London, UK. This investigator-sponsored phase I clinical study was designed to assess safety, tolerability and clinical responses against metastatic melanoma after administration of plasmid-based IL-12 delivered intratumorally by Inovio's electroporation system. Twenty four patients were treated at seven escalating dose levels. No dose-limiting toxicity was noted. Observations from these results include:
Avtar Dhillon, MD, president and CEO of Inovio, said: "While this data further reinforces the safety of Inovio's electroporation-based delivery technology, we are also pleased to see the evidence of clinical benefit achieved by a DNA-based immunotherapy delivered using our technology in a difficult-to-treat disease such as melanoma. These results further build our optimism that our electroporation technology may be the key to unlocking the benefits of multiple DNA-based immunotherapies and DNA vaccines such as those currently advancing through clinical studies against cancers and hepatitis C virus. We are now evaluating the possibility of a phase II clinical study of this plasmid IL-12 immunotherapy using our DNA delivery technology."
Melanoma is the most serious form of skin cancer. It is not the most common of the skin cancers, but causes the most deaths. The American Cancer Society estimated that in 2007 in the U.S. there would be 8,110 deaths from melanoma and 59,940 new incidences.
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 (http://www.moffitt.org) is the only Florida-based cancer center with 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 DNA vaccines. Inovio is a leader in developing human applications of electroporation using brief, controlled electrical pulses to increase cellular uptake of a useful biopharmaceutical. Human data has shown that Inovio's electroporation-based DNA delivery technology can significantly increase gene expression and immune responses from DNA vaccines. Immunotherapy partners include Merck, Wyeth, Vical, University of Southampton, Moffitt Cancer Center, the U.S. Army, National Cancer Institute, and International Aids Vaccine Initiative. Inovio's technology is protected by an extensive patent portfolio covering in vivo electroporation. More information is available at http://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 clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications and that results from one study may necessarily not be reflected or supported by the results of other similar studies), 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 our Annual Report on Form 10-K for the year ended December 31, 2006, our 10-Q for the nine months ended September 30, 2007, and other regulatory filings from time to time. There can be no assurance that any product in our product pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proved accurate.