Inovio Biomedical Provides Updated Interim Data on Phase I/II Clinical Study of Electroporation-Delivered Prostate Cancer DNA Vaccine at ASGT Annual Meeting
This academic study is a phase I/II study of 30 HLA A2+ patients with biochemical failure of prostate cancer. The study is testing a DNA fusion vaccine, developed in Southampton, encoding for an immunostimulant sequence from tetanus linked to a sequence from prostate specific membrane antigen (PSMA27). The study is also evaluating electroporation as a novel delivery strategy for DNA vaccines compared to DNA delivered without electroporation.
Patient enrollment for this study has been completed. Monitoring of antibody responses was completed for the 20 patients at the first and second dose levels. Monitoring of CD4 cellular immunity has been completed for the 10 patients at the lowest dose. These 10 patients have additionally been assessed for CD8 T-cell responses. Interim results to date include:
-- Vaccination with and without electroporation has been safe and well-tolerated.
-- 14 of 20 patients developed increases in anti-DOM (the immunostimulant sequence from tetanus) antibody. Of these increased responses, 5 of 10 were in the arm not using electroporation; 9 of 10 were in the electroporation arm. Antibody responses were generally higher in patients treated using electroporation compared to those treated with the DNA vaccine alone (without electroporation).
-- In 9 of 10 patients in the low dose cohort, significant increases in CD4 responses were observed relative to pre-treatment. Of these increased responses, 4 of 5 were in the electroporation arm. Patients treated exclusively with electroporation produced a higher average CD4 response; patients initially treated without electroporation and later receiving a boost in conjunction with electroporation also displayed increased CD4 responses following the electroporation boost.
-- In the low dose cohort, the PSMA27 antigen induced CD8+ cytotoxic T-cells (measured by cultured IFNg ELISPOT) not detected before vaccination in 6 of 10 subjects.
Avtar Dhillon, MD, president and CEO of Inovio, said: "We are pleased that this phase I/II clinical study not only established the tolerability of this therapy against prostate cancer but that over time it is continuing to validate the safety of a DNA vaccine delivered using our electroporation DNA vaccine delivery technology. Also important is the heightened immune response achieved using electroporation compared to injection of the DNA vaccine without electroporation."
To listen to an online interview with Dr. Christian Ottensmeier, please click here. Dr. Ottensmeier discusses the use of electroporation to enhance the potency and delivery of DNA vaccines.
About the University of Southampton
The 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 5,000 staff. Its annual turnover is in the region of GBP 310 million. www.soton.ac.uk
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 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, 2007, our 10-Q for the three months ended March 31, 2008 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.
Bernie Hertel, 858-410-3101
Ronald Trahan Associates Inc.
Ron Trahan, 508-359-4005, x108
Posted: June 2008