The systemic delivery of high-dose recombinant IL-2 to treat melanoma is limited by significant toxicity. An alternative method for extended dosing of IL-2 that may reduce toxicity is by intratumoral injection (followed by electroporation to facilitate cellular uptake) of a plasmid DNA designed to produce IL-2 in the body. The primary objective of this ongoing Phase I pDNA IL-2/electroporation study is to evaluate the safety and tolerability of the latter approach in stage three and four metastatic melanoma patients. In the first stage of the trial, four treatment groups received escalating doses of 0.5, 1.5, 5 (mg per tumor), and 15 mg (5 mg in each of 3 tumors). In the ongoing second stage, patients are treated with the 15 mg dose.
The interim study results show that no serious adverse events related to the study drug or administration procedure have been reported and the treatment was well tolerated. The majority of related adverse events were localized to the treatment site, with the most frequent being mild injection site pain.
Objective tumor responses, defined as 50% tumor shrinkage or complete disappearance, were observed in 12 of 39 (31%) of the lesions that were targeted for observation. Of these observed lesions, seven of 18 treated tumors (38%) and five of 21 untreated tumors (24%) showed objective responses. The response of untreated tumor lesions suggests the possibility of a systemic effect of the treatment. Two subjects showed activity in untreated tumors distant from the site of administration of the therapy, including one subject showing shrinkage and disappearance of lung tumors.
"This is the third set of interim clinical data to be released this year supporting the safety and tolerability of Inovio's electroporation technology for delivering DNA immunotherapeutics in humans. The objective tumor responses observed by Vical add to a body of data suggesting that electroporation of plasmid-based immunotherapeutics can induce immune and anti-tumor responses," said Dr. Avtar Dhillon, Inovio's President and CEO. "We look forward to advancing the business opportunities that become more apparent with such results."
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 manufacture d 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 these plasmid DNA-based immunotherapeutics and have been shown in primate studies and interim Phase I data to significantly enhance antibody and T-cell immune responses over plasmid DNA delivered by other methods, suggesting the potential to provide a better protective or therapeutic effect against complex infectious diseases as well as 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 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. In the case of DNA vaccines, Inovio's technology has shown it can significantly increase levels of gene expression and immune response. 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. 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 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 three months ending March 31, 2007, 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.
Inovio Biomedical Corporation
Bernie Hertel, 858-410-3101
Jeff Richardson, 805-491-8313