Three presentations reported preclinical data regarding immune responses to DNA vaccines directed against major infectious diseases including malaria, HIV, and hepatitis C, respectively. In all cases, Inovio's electroporation technology was well tolerated and significantly enhanced both humoral (antibody) and cellular (T-cell) immune responses when compared with traditional vaccine delivery methods.
A study conducted in collaboration with the Naval Medical Research Center showed that electroporation-augmented immunization with a DNA vaccine against a malaria parasite-specific antigen not only enhanced humoral and cellular immune responses, but more importantly caused a significant reduction of parasite burden compared to non-immunized control animals.
A study conducted in partnership with Wyeth tested a multi-antigenic DNA vaccine against HIV. Using only one-fifth the dose used without electroporation, antibody responses were increased several hundred-fold by electroporation. The cellular immune response was enhanced 10 to 40-fold, translating into a 50 to 200-fold increase (8 weeks and 22 weeks, respectively) in vaccine potency.
A third study conducted in partnership with the Karolinska Institute, Sweden, supported the safety of electroporation in detailed experiments a nd demonstrated that the electroporation-enhanced immune responses to a hepatitis C DNA vaccine were capable of eliminating all liver cells that produced a model hepatitis C virus gene, simulating a potential cure of hepatitis C infection. Vaccination by methods not employing Inovio's technology were less or not effective.
Two other Inovio presentations reported electroporation device innovations including the Elgen 1000 system and a single-needle device. The Elgen 1000 system, which recently received CE marking, consists of an advanced pulse generator and a two-needle DNA injector that delivers the genes and electroporation pulses in a single step. The pulse generator allows flexible programming of pulse and injection parameters via a flash card operated personal computer, as well as comprehensive recording and storage of electroporation and patient data. The single needle device, in early development, allows injection of the DNA and electroporation with a single needle resembling a normal injection needle and applies pulses of lower voltage than those delivered by presently used devices, thus reducing the electrical sensation experienced by the patient.
"We are pleased with the performance of our DNA delivery technology in advanced preclinical studies. Together with our continuing innovations in electroporation devices, our technology may be able to make critical contributions to the development of novel, effective vaccines for the treatment or prevention of major life-threatening infectious diseases," said Dr. Avtar Dhillon, Inovio's president and CEO.
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 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, Unive rsity 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 signif icant 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 (Investor Relations), 858-410-3101
Jeff Richardson (Media Relations), 805-491-8313