Inovio Biomedical’s DNA Delivery Technology
Significantly Enhances Potency of Gene-Based Prostate Cancer
Key Milestone for First-in-Man DNA Vaccine Clinical Trial Using Inovio’s Electroporation DNA Delivery Technology
SAN DIEGO, May 22, 2007 -- Inovio Biomedical Corp. (AMEX: INO), focused on the development of DNA-based vaccines for cancers and infectious diseases and a novel alternative to surgery to treat localized cancers, announced today that interim data from a clinical study of an experimental DNA-based prostate cancer vaccine demonstrated that Inovio’s DNA delivery technology significantly enhanced the potency of the gene-based vaccine.
Dr. Christian H. Ottensmeier, MD, PhD, Cancer Research UK Senior Clinical Research Fellow at the University of Southampton, will present interim data at the 3rd International Conference on DNA Vaccines in Malaga, Spain, from this University of Southampton Phase I/II clinical study of a prostate cancer vaccine, a proprietary product owned by a third party, delivered by Inovio’s electroporation technology. The results demonstrated safety, tolerability and significantly higher antibody responses for patients who received the vaccine with Inovio’s delivery system versus those who were treated without it. Inovio’s electroporation-mediated DNA delivery system is designed to enhance the potency of DNA-based immunotherapies against cancers and infectious diseases.
Inovio Biomedical has been collaborating with Dr. Ottensmeier since 2005 on this University of Southampton clinical study, titled “A Phase I-II Trial of a DNA Vaccine with a PSMA27/pDOM Fusion Gene Given by Intramuscular Injection in HLA2+ Patients with Prostate Carcinomas with or without Electroporation.” This study of patients with recurrent prostate cancer, approved by the United Kingdom Medicines and Healthcare Products Regulatory Agency, is assessing safety, tolerability, and cellular (T-cell) and humoral (antibody) immune responses to a novel plasmid-based cancer vaccine delivered using Inovio’s proprietary DNA delivery technology. In each of the two arms of this study, i.e. with and without electroporation-enhanced delivery, three patient groups are being treated using escalating dosage levels. A total of 24 patients have been treated out of a total objective of 30 patients.
An analysis of interim data from the first and partially from the second dose treatment groups demonstrated the following points:
1. Electroporation appears safe and it is well tolerated.
2. The number of patients with significant antibody responses was four of 10 in the patient groups treated without electroporation compared to nine of 10 in the patient groups treated with electroporation.
3. The magnitude of the antibody response was significantly higher in patients treated using electroporation. Data on the T-cell response is being compiled.
The investigators continue to enroll and treat patients in the higher-dosage treatment groups.
“These data demonstrate for the first time in a clinical trial that the significant enhancement in potency of a gene- based vaccine delivered by electroporation in animals can also be seen in humans,” said Dr. Christian Ottensmeier, clinical investigator of the study.
“Achieving validation that the compelling pre-clinical data generated by Inovio and partners in large animal models can be achieved in humans is a key milestone for Inovio,” stated Avtar Dhillon, MD, Inovio’s CEO. “These results suggest that Inovio’s electroporation DNA delivery technology may provide an important alternative to viral and other DNA delivery technologies and could play a profound role in safely augmenting the immune response generated by future prophylactic and therapeutic immunot herapies against cancers and infectious diseases such as HIV and hepatitis C,” added Dr. Dhillon.”
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 the University of Southampton
T he University of Southampton is a leading UK teaching and research institution with a global reputation for leading-edge research and scholarship. It is one of the UK’s top 10 research universities, offering first-rate opportunities and facilities for study and research across a wide range of subjects in humanities, health, science and engineering. The University has around 20,000 students and over 5000 staff. Its annual turnover is in the region of £310 million. www.soton.ac.uk
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 DNA delivery 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 the predominantly healthy tissue typically treated around a tumor. The SECTA therapy 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 neck 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 our Annual Report on Form 10-K for the year ended December 31, 2006, our Form 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.* * *
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