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San Diego, US | Jan 17, 2006 | Inovio Biomedical Corporation (AMEX:INO), a late stage developer of cancer and other therapies using electroporation to deliver drugs and nucleic acids, announced today that it has signed an agreement with Swedish-based Tripep AB (The Stockholm Exchange:TPEP) to develop a therapeutic vaccine for hepatitis C virus (HCV). The vaccine will be based on Tripep's proprietary HCV antigen and delivered to infected individuals using Inovio's Medpulser DNA Delivery System. Initiation of a phase I clinical trial is expected to begin in 2006 and will be performed in Sweden.
Hepatitis C virus is a major cause of chronic liver disease worldwide. The standard treatment for HCV, combination therapy with pegylated interferon alfa and ribavirin, has limited efficacy, poor tolerability, and significant expense. New treatment options that are more potent and less toxic are desperately needed.
The U.S. HCV market is currently calculated at $1.4 billion, representing 100,000 people treated each year. It is estimated that between 15 and 20 million people are chronically infected with HCV in the industrial world, translating to a worldwide hepatitis C treatment market of about $2.5 billion.
Electroporation-based delivery of DNA-based vaccines is an enabling mechanism that enhances immune responses in several key ways. Electroporation increases both the onset and titers of antibodies and T cells to DNA-encoded antigens. The ability to enhance cellular immune responses is thought to be necessary to control persistent viral infections such as HCV. Induction of both antibodies and T-cells may boost the ability of the patient's immune system to recognize and destroy infected cells.
"The ability of electroporation-delivered DNA vaccines to enhance both cell mediated and humoral immune responses may create a new paradigm for the treatment of viral hepatitis," said Avtar Dhillon, MD, Inovio's president and CEO. "While we are currently involved in four phase I studies using the MedPulser® System to deliver DNA therapeutics, this agreement with Tripep represents our first step to secure full rights to a product."
"The combination of Tripep's ChronVac® vaccine and Inovio's Medpulser(TM) DNA Delivery System may become a completely new form of therapy for the treatment of chronic hepatitis C virus infection, a disease that can have a devastating impact on a large number of patients," said Jan Nilsson, CEO of Tripep.
The terms of the development agreement call for each party to fund a portion of the phase I and subsequent phase II trials and share profit according to their contribution. Inovio will initially get a 33% ownership in the overall product with the option to increase this to 50% after the completion of the phase 1 trial.
Background on DNA Vaccines
DNA vaccines delivered to the muscle with electroporation are of interest to the medical community primarily because they are effective at triggering rapid and robust cellular and humoral immune responses that are difficult to achieve with conventional vaccine technology.
DNA vaccines can be rapidly manufactured in large quantities using standard bacterial culture media, can be stored at room temperature, and can be made synthetically. Ease of manufacture and characterization make DNA vaccines amenable to rapid clinical development.
Background on the MedPulser® System
Inovio's MedPulser® system enables significant local cellular uptake of useful biopharmaceuticals. Using electroporation, the application of brief electrical pulses to create permeability in cell membranes, Inovio's technology increases the uptake and gene expression of locally injected DNA plasmids. Non-human primate studies have shown that the Medpulser DNA Delivery System can be safely used to increase the immune response to a plasmid-based vaccines by 100 to 1000 fold.
About Inovio Biomedical Corporation
Inovio Biomedical Corporation is a late stage biomedical company focused on commercializing its proprietary Selective Electrochemical Tumor Ablation (SECTA) therapy. SECTA targets a significant unmet clinical need: the local treatment of solid tumors, with selective killing of cancer cells while preserving healthy tissue. Inovio is moving its lead product, the MedPulser®, through pre-marketing studies for head and neck cancer and skin cancers in Europe, where it has CE Mark accreditation, a U.S. Phase III pivotal study for head and neck cancer, and Phase I trials for pancreatic and breast cancer. Merck, Vical, University of Southampton, and H. Lee Moffitt Cancer Center are using Inovio's gene delivery technology in clinical studies of novel DNA therapeutics delivered using electroporation. Inovio is a leader in developing human therapeutic applications of electroporation, with the industry's most 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 and to maximize shareholder value. 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, evaluation of potential opportunities, the level of corporate expenditures, the assessment of our technology by potential corporate partners, capital market conditions, and other factors set forth in the our Annual Report on Form 10-K for the twelve-month period ended December 31, 2004, and our Form 10-Q for the three months ended September 30, 2005, 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.
CONTACT: Inovio Biomedical Corporation
Bernie Hertel, 858-410-3101
Investor Relations
or
Atkins + Associates
Rebecca Wong, 858-527-3495
Media Relations
Source: Inovio Biomedical Corporation |
