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Inovio Biomedical and University of Southampton Collaboration: Initiation of Phase I/II Clinical Trial in Patients With Recurrent Prostate Cancer

Posted on: Monday, 4 April 2005, 09:00 CDT

Inovio Biomedical Corporation (AMEX:INO), which is developing oncology and other therapies using electroporation to deliver drugs and nucleic acids, announced today the initiation of a UK Medicines and Healthcare products Regulatory Agency (MHRA) approved Phase I/II clinical trial undertaken in collaboration with the University of Southampton. Inovio's DNA delivery technology will be used to deliver a therapeutic plasmid-based DNA vaccine to skeletal muscles with the aim of treating recurrent prostate cancer. The trial, sponsored and led by the University of Southampton, will investigate whether the DNA vaccine, developed in the laboratory of Professor Freda Stevenson at the University of Southampton, can stimulate patients to develop immune responses against prostate cancer and whether use of Inovio's electroporation system enhances this response.

In this Phase I/II open-label study, plasmid DNA encoding a prostate tumor antigen is delivered directly to skeletal muscles in patients with recurrent prostate cancer either by simple injection or using Inovio's proprietary DNA delivery system. This technology uses electroporation to enable the entry and uptake of plasmid DNA into the muscle cells. It has been shown in preclinical studies to induce antigen production and generation of an immune response against the tumor antigen.

"Available treatments for recurrent prostate cancer are intended primarily to only slow disease progression," stated Avtar Dhillon, MD, president and CEO of Inovio. "We are excited to partner with these pioneering scientists at the University of Southampton in what we believe is the first use of electroporation to deliver DNA vaccines in human skeletal muscle with the goal of achieving therapeutic benefits. Using this system, we hope to improve the quality of life of these prostate cancer patients."

"Preclinical models with electroporation-enabled delivery of a plasmid-based DNA vaccine showed significant induction of specific immune responses," stated Dr. Christian Ottensmeier, Cancer Research UK senior research fellow and chief investigator at the University of Southampton.

About Prostate Cancer

Prostate cancer is the second leading cause of cancer death in American men, and the most common non-skin cancer in American men. Approximately one in six men will be diagnosed with prostate cancer during his lifetime. The American Cancer Society estimates that during 2005, about 232,090 new cases will be diagnosed and 30,350 men will die of prostate cancer in the US.

Decisions about treatments for prostate cancer are not easy to make. About 80% of men diagnosed with prostate cancer have early stage disease, but it is difficult for a physician to predict whether a tumor will grow slowly with no health consequences to the patient, or will grow quickly and become life-threatening. A physician can choose among watchful waiting (following the patient closely and postponing aggressive therapy unless symptoms of the disease progress), or treating with radiation therapy, radical prostatectomy (surgical removal of the entire prostate gland along with nearby tissues), or hormonal therapies. These treatments of prostate cancer can have detrimental effects on urinary, bowel and sexual functions, compromising patient quality of life.

Background on the MedPulser(R) System

Inovio's MedPulser(R) Electroporation Therapy System significantly enhances local cellular uptake of useful biopharmaceuticals, including DNA. Animal experiments have shown that this technology can be used to enhance the effect of plasmid-based DNA vaccines.

Inovio is commercializing a cancer therapy that uses its MedPulser(R) electrochemical tumor ablation system in conjunction with bleomycin, an approved anti-cancer drug, with the goal of improving quality of life while reducing costs compared to existing treatment methods. The MedPulser(R) has received the European CE Mark and Inovio is conducting multi-center, pre-marketing observational studies treating newly diagnosed and recurrent head and neck cancers as well as skin cancers in preparation for a planned European product launch. These studies are measuring quality of life and pharmacoeconomic outcomes. In the U.S., Inovio completed a Special Protocol Assessment with the Food and Drug Administration (FDA), which approved clinical studies measuring quality of life as the primary endpoint. The Company is conducting two pivotal Phase 3 trials for recurrent and second primary squamous cell carcinomas of the head and neck. The FDA granted fast track status for these trials.

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. The University has around 20,000 students and nearly 5000 staff. Its annual turnover is in the region of GBP 270 million.

About Inovio Biomedical Corporation

Inovio Biomedical Corporation is a late stage biomedical company focused on building an oncology franchise based on its proprietary electroporation therapy. The therapy targets a significant unmet clinical need: the selective killing of cancer cells and local ablation of solid tumors while preserving healthy tissue. The company is moving its lead product, the MedPulser(R) Electroporation Therapy System, 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 recurrent head and neck cancer, and a Phase I pancreatic cancer trial. Merck, Vical, Chiron, the U.S. Navy, and other partners are employing Inovio's electroporation technology, which enhances local delivery and cellular uptake of useful biopharmaceuticals, in their development of novel DNA vaccines and gene therapies. Inovio is a leader in electroporation, with 57 US and 125 corresponding foreign issued patents, plus numerous pending patents in the US and abroad. More information can be obtained at www.inovio.com.

This press release contains certain forward-looking statements relating to Inovio's plans to develop its electroporation drug and gene delivery technology and to maximize shareholder value. Actual events or results may differ from Inovio's 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 Inovio's technology by potential corporate partners, capital market conditions, and other factors set forth in the Inovio's Annual Report on Form 10-K for the 12-month period ended December 31, 2004, and other regulatory filings. There can be no assurance that any product in the Inovio 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.

Source: Business Wire

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