Recurrent Metastatic Melanoma - Phase 1 Trial Of Gene-Based IL-2 With Inovio Electroporation Technology

Main Category: Melanoma / Skin Cancer
Article Date: 21 Jul 2005 - 0:00 PDT

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Inovio Biomedical Corporation (AMEX: INO) and Vical Incorporated (Nasdaq:VICL) announced today the initiation of a human Phase 1 study of an investigational method of delivering interleukin-2 (IL-2), a potent immune system stimulant, for patients with recurrent metastatic melanoma. Intravenous delivery of IL-2 protein is approved as a treatment for metastatic melanoma, but frequently causes severe systemic toxicities. The novel treatment approach being studied in this trial involves direct injection into a tumor lesion of plasmid DNA (pDNA) encoding IL-2 followed by electroporation, the local application of electrical pulses designed to enhance the uptake of the pDNA into tumor cells. The pDNA is designed to cause cells within the tumor to produce high levels of IL-2 protein locally and stimulate the immune system to attack the tumor without the associated systemic toxicities.

Inovio's President and Chief Executive Officer, Avtar Dhillon, M.D., said, "We are pleased that Vical's preclinical work has justified advancing this program into humans. Vical is the first of our corporate partners to initiate a clinical study using our electroporation technology to enhance delivery of a gene with potential therapeutic benefits in humans."

Vical's President and Chief Executive Officer, Vijay B. Samant, said, "We are pleased to advance to human safety testing our first application of the electroporation technology licensed from Inovio. The combination of non-viral, gene-based delivery with electroporation may provide sustained local expression of IL-2 at therapeutic levels without the toxicity associated with systemic delivery. Our encouraging preclinical data using this approach was recently presented at the annual meeting of the American Association for Cancer Research."

Treatments will be administered once a week in two four-week cycles, with each cycle followed by a four-week observation period. The initial dose-escalation phase of the trial will enroll up to three patients each at doses of 0.5 mg, 1.5 mg and 5 mg delivered to a single tumor lesion per patient, with a final group receiving 5 mg in each of three tumor lesions per patient. Up to 17 additional patients will be treated at the highest tolerated dose. The primary endpoint in the trial is safety. Secondary efficacy endpoints will also be monitored.

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. Inovio is moving its lead product, the MedPulserR 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 U.S. and 125 corresponding foreign issued patents, plus numerous pending patents in the U.S. and abroad. More information can be obtained at http://www.inovio.com.

About Vical

Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company has retained all rights to its internally developed product candidates. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and serve significant unmet medical needs. Additional information on Vical is available at http://www.vical.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 our Annual Report on Form 10-K for the twelve-month period ended December 31, 2004, and our Form 10-Q for the three-month period ended March 31, 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:
Investor Relations
Bernie Hertel
(858) 410-3101
http://www.inovio.com

Vical Incorporated:
Investor Relations
Alan R. Engbring
(858) 646-1127
http://www.vical.com

Media Relations:
Atkins + Associates
Susan Neath
Phone: (858) 527-3486
Rebecca Wong
Phone: (858) 527-3495

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